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U.S. label record↗Metabolic↗

Liraglutide↗

Related names in cited records: Saxenda↗

A GLP-1 receptor agonist. This profile cites a U.S. label record.↗

Citation markers ↗ open the public records supporting the adjacent statements.

Profile update · July 29, 2026

We added a product-name lookup term that the cited FDA label communication connects to liraglutide. The profile's status did not change. 2

This version supersedes public version 2.

Start here

The evidence at a glance

What is its status in the cited records?

U.S. label record. The cited DailyMed label identifies Liraglutide and contains the product's official indications and warnings. This profile links to the label without restating it as medical guidance.↗

Status sources checked through July 22, 2026. See status sources and coverage →

What do the reviewed human studies say?

Human evidence reviewed August 19, 2026 · Review version 1.

Review source snapshots checked August 19, 2026 · Integrity checked August 19, 2026.

A bounded review of two sponsor-funded randomized trials: one 56-week weight-management trial and one cardiovascular-outcomes trial in type 2 diabetes.↗↗

What the reviewed sources report

The reviewed weight-management trial reported greater mean weight reduction than placebo, and the reviewed cardiovascular trial reported fewer primary cardiovascular events in a high-risk type 2 diabetes population. The findings remain specific to the studied populations and trial conditions.↗↗

What remains unresolved?

  • How do benefits and harms vary in lower-risk populations, after discontinuation, and over follow-up beyond the reviewed trials?↗↗

Read study designs, results, limitations, and sources →

What does the U.S. product label say?

Liraglutide injection for weight management · Read September 15, 2026 · Preserved label summary 1

Which population and use does the label cover?

The cited generic injection label covers long-term weight reduction alongside diet and activity in adults with obesity or overweight with a weight-related condition, and children aged twelve years and older with obesity and body weight above 60 kg. It does not establish the scope of every liraglutide product. Label: 1 ↗

Which safety limits matter?

The boxed warning reports thyroid C-cell tumors in rodents, with uncertain human relevance. Contraindications include personal or family medullary thyroid carcinoma, MEN 2 and hypersensitivity. Other warnings address pancreatitis, gallbladder disease, hypoglycemia, increased heart rate, kidney injury from volume depletion, severe gastrointestinal reactions and aspiration during anesthesia or deep sedation. Label: boxed warning, 4, 5 ↗

Label edition and source pins

U.S. product labeling hosted by the National Library of Medicine. This account concerns this product and label edition; other formulations and jurisdictions require their own records.

Liraglutide injection, solution · SPL version 6 · published 2026-07-14

Label ZIP SHA-256: 48d493b4dc6af7d7574aedf0a2f7ab6235a9ed62875baffe6c484b5433647541. Extracted XML SHA-256: 26e94f7191fa24c8a25945ac1cd23ef4a95e897a8c9e84520043a4d7ff6edbef.

Open versioned label context data →

Reviews summarize selected studies; their scope and limitations are shown above.

Inside the official reviews

Reviewed 2026-09-19 · Preserved version 1

The initial glycemic trials and later outcomes trial answer different questions

EMA’s 2009 assessment primarily evaluated glucose control with specific background therapies and comparators. The later LEADER assessment directly evaluated cardiovascular events in a high-risk type 2 diabetes population. EMA PDF pp. 45 ↗EMA PDF pp. 78 ↗

More findings, study links and document coverage

LEADER measured clinical cardiovascular events

The 9,340-participant randomized trial added liraglutide or placebo to standard care. Over median observation of 3.84 years, first major cardiovascular events occurred in 13.0% versus 14.9%; the hazard ratio was 0.87 (95% CI 0.78–0.97). EMA PDF pp. 78 ↗

Do not generalize the high-risk population to everyone

EMA considered the principal endpoint reliable but cautioned about exploratory findings. Results in people with risk factors alone were less consistent; the study did not establish an unrestricted first-line treatment claim for newly diagnosed diabetes. EMA PDF pp. 84, 85, 87 ↗

A composite kidney result is not every kidney outcome

The exploratory nephropathy result was mainly driven by new macroalbuminuria. No differences were found for renal replacement therapy or doubling of creatinine in that analysis; these components should not be presented as equivalent findings. EMA PDF pp. 79 ↗

Read the separate U.S. label account → Label version and indication scope are preserved there; these agency reviews describe their own dated evidence.

Matched study identities

Protocol identifiers were matched to ClinicalTrials.gov records. This does not count extensions as new independent trials.

Document coverage

Selected sections read in 2 of 35 inventoried documents; 33 not yet reviewed. Reading selected sections does not establish complete appraisal of a document.

Selected English EMA PDFs from the retained September 15, 2026 title-matched document feed, plus independently retrieved FDA approval-package documents where listed. Candidate entries are not verified product/application matches. This is a bounded inventory, not a complete FDA, national or worldwide source search. EMA inventory source ↗

Inspect documents, application identities and source pins

Page references use one-based PDF file pages, which can differ from printed page numbers. Candidate feed associations are not verified application identities.

Remaining work

  • Appraise Saxenda weight-management and pediatric documents separately from the Victoza diabetes program.
  • Complete the remaining variation, safety and study-level readings in the candidate inventory.

Open versioned document coverage and study pins →

European medicine records · 5 products or applications

EMA medicine metadata checked 2026-09-15. These are product-specific centralized records; national European authorizations and full product-information assessments require separate coverage.

Application withdrawal and refusal are distinct from marketing authorization. A withdrawal status alone does not establish why it occurred. These metadata entries do not substitute for indication, population or safety details in the relevant product information.

Open versioned records and source-feed pins →

Research coverage and study families

Search and screening record checked 2026-09-15. Counts describe records, not independent trials. Full-text appraisal is separate from an abstract review.

Open machine-readable coverage and record decisions →

PubMed search

Catalog-name and calibrated alias discovery for human evidence review. Complete query retrieval is separate from clinical eligibility, study-family linkage and appraisal.

5625 retrieved · 2 included · 0 excluded · 5623 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

"Liraglutide"[Title/Abstract] OR "Saxenda"[Title/Abstract]

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:09:36.495785+00:00 · HTTP 200 · SHA-256 1cfce35fa93d082bb580f40b718ff2704d5677380309e20a8be7757e5928004d.

  • Retrieved IDs completely represent this query response, not all relevant literature. Additional aliases, references and non-PubMed sources require separate searches.
  • Unscreened records may include animal or cell experiments, reviews, secondary analyses, mixtures, protocols and unrelated name matches.
  • Study-family mappings use available declared registry IDs; unresolved mappings do not create independent trial counts. Full-text, corrections and registry comparison remain separate work.

Showing 25 of 5625 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. PubMed 27295427 — include: Selected published human report; abstract reviewed. Full-text and study-family appraisal remain separate. Study families: NCT01179048.
    Bibliographic record recheck · 2026-09-15

    The selected PubMed XML payload matches the previous reviewed snapshot. This is a metadata recheck, not a new appraisal or a finding that no corrections exist. Open PubMed record ↗

    SHA-256 d86dca944a90d406ed7a98e6e46eb8d9774504c7746b167351df04f923325e26.

  2. PubMed 26132939 — include: Selected published human report; abstract reviewed. Full-text and study-family appraisal remain separate. Study families: NCT01272219.
    Bibliographic record recheck · 2026-09-15

    The selected PubMed XML payload matches the previous reviewed snapshot. This is a metadata recheck, not a new appraisal or a finding that no corrections exist. Open PubMed record ↗

    SHA-256 5c94f293c86af2a279cfa8ae529f06100cf2dce79b2009b0a6ba26fb9ca9bce6.

  3. PubMed 42737442 — not screened: Name-query match awaiting clinical eligibility screening.
  4. PubMed 42736522 — not screened: Name-query match awaiting clinical eligibility screening.
  5. PubMed 42736040 — not screened: Name-query match awaiting clinical eligibility screening.
  6. PubMed 42736027 — not screened: Name-query match awaiting clinical eligibility screening.
  7. PubMed 42732089 — not screened: Name-query match awaiting clinical eligibility screening.
  8. PubMed 42730869 — not screened: Name-query match awaiting clinical eligibility screening.
  9. PubMed 42729958 — not screened: Name-query match awaiting clinical eligibility screening.
  10. PubMed 42727920 — not screened: Name-query match awaiting clinical eligibility screening.
  11. PubMed 42726083 — not screened: Name-query match awaiting clinical eligibility screening.
  12. PubMed 42725235 — not screened: Name-query match awaiting clinical eligibility screening.
  13. PubMed 42723821 — not screened: Name-query match awaiting clinical eligibility screening.
  14. PubMed 42723672 — not screened: Name-query match awaiting clinical eligibility screening.
  15. PubMed 42718598 — not screened: Name-query match awaiting clinical eligibility screening.
  16. PubMed 42708757 — not screened: Name-query match awaiting clinical eligibility screening.
  17. PubMed 42697206 — not screened: Name-query match awaiting clinical eligibility screening.
  18. PubMed 42695487 — not screened: Name-query match awaiting clinical eligibility screening.
  19. PubMed 42695140 — not screened: Name-query match awaiting clinical eligibility screening.
  20. PubMed 42693519 — not screened: Name-query match awaiting clinical eligibility screening.
  21. PubMed 42692655 — not screened: Name-query match awaiting clinical eligibility screening.
  22. PubMed 42692477 — not screened: Name-query match awaiting clinical eligibility screening.
  23. PubMed 42692277 — not screened: Name-query match awaiting clinical eligibility screening.
  24. PubMed 42692107 — not screened: Name-query match awaiting clinical eligibility screening.
  25. PubMed 42687799 — not screened: Name-query match awaiting clinical eligibility screening.

FDA search

Active-ingredient name query in openFDA Drugs@FDA. Returned application identities include salt forms and combination products; exact indications, approval conditions, supplements and marketing status require document-level review.

14 retrieved · 14 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

products.active_ingredients.name:"LIRAGLUTIDE"

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:10:19.744283+00:00 · HTTP 200 · SHA-256 18a2acd6a79a9dbd68ed860f7cb4c15c66227e6e8f5992f91aa507e78ee76d04.

  • Zero results describe this query response only, not absence of FDA approval or worldwide nonapproval.
  • This endpoint does not inventory every label, advisory proceeding, safety communication or regulatory document. Application inclusion does not establish current marketing or approval of every use.

Showing 14 of 14 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. FDA NDA206321 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LIRAGLUTIDE.
  2. FDA ANDA215503 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LIRAGLUTIDE.
  3. FDA BLA208583 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: INSULIN DEGLUDEC, LIRAGLUTIDE.
  4. FDA ANDA217234 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LIRAGLUTIDE.
  5. FDA ANDA218115 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LIRAGLUTIDE.
  6. FDA ANDA213155 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LIRAGLUTIDE.
  7. FDA ANDA215245 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LIRAGLUTIDE.
  8. FDA ANDA212552 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LIRAGLUTIDE.
  9. FDA NDA022341 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LIRAGLUTIDE.
  10. FDA ANDA217063 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LIRAGLUTIDE.
  11. FDA ANDA212972 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LIRAGLUTIDE.
  12. FDA ANDA214568 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LIRAGLUTIDE.
  13. FDA ANDA215421 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LIRAGLUTIDE.
  14. FDA ANDA217590 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: LIRAGLUTIDE.

EMA search

Local matching in the pinned EMA medicines feed; document matches also use identified EMA product numbers. This is not every national European record.

5 retrieved · 5 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

Case-insensitive word-boundary identity terms: ["Liraglutide", "Saxenda"]

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T08:34:22.905972+00:00 · HTTP 200 · SHA-256 a947c2b8a56ac2b92ec96156843f262f5e516f83b375d6791d67a8f6dc695729.

  • Document appraisal and national European sources remain open.
  • Zero matches apply only to these feed fields and terms; orphan designation is not approval.

Showing 5 of 5 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. EMA EMEA/H/C/006620 — include: EMA feed product Ablymico; reported status: Authorised. Exact indication and decision documents remain unappraised.
  2. EMA EMEA/H/C/006615 — include: EMA feed product Liraglutide STADA; reported status: Authorised. Exact indication and decision documents remain unappraised.
  3. EMA EMEA/H/C/001026 — include: EMA feed product Victoza; reported status: Authorised. Exact indication and decision documents remain unappraised.
  4. EMA EMEA/H/C/003780 — include: EMA feed product Saxenda; reported status: Authorised. Exact indication and decision documents remain unappraised.
  5. EMA EMEA/H/C/002647 — include: EMA feed product Xultophy; reported status: Authorised. Exact indication and decision documents remain unappraised.

EMA search

Local matching in the pinned EMA documents feed; document matches also use identified EMA product numbers. This is not every national European record.

79 retrieved · 55 included · 0 excluded · 24 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

Case-insensitive word-boundary identity terms: ["Liraglutide", "Saxenda"]

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T08:34:29.167460+00:00 · HTTP 200 · SHA-256 c0c68d7d77783e0355cbc75bdd04772e9acc163236fc68abcd794477c4c3d439.

  • Document appraisal and national European sources remain open.
  • Zero matches apply only to these feed fields and terms; orphan designation is not approval.

Showing 25 of 79 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. EMA 5631 — include: Document linked by EMA product number; content unappraised. Xultophy : EPAR - Public assessment report
  2. EMA 8772 — include: Document linked by EMA product number; content unappraised. Xultophy-H-C-2647-II-0002 : EPAR - Assessment Report - Variation
  3. EMA 8989 — include: Document linked by EMA product number; content unappraised. Saxenda-H-C-PSUSA-00001892-201512 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
  4. EMA 10275 — include: Document linked by EMA product number; content unappraised. Victoza : EPAR - Assessment Report - Variation
  5. EMA 11269 — include: Document linked by EMA product number; content unappraised. Xultophy : EPAR - Medicine overview
  6. EMA 12669 — include: Document linked by EMA product number; content unappraised. Victoza-H-C-1026-II-0005-G : EPAR - Assessment Report - Variation
  7. EMA 13799 — include: Document linked by EMA product number; content unappraised. Saxenda-H-C-3780-P46-017 : EPAR - Assessment Report
  8. EMA 19530 — include: Document linked by EMA product number; content unappraised. Xultophy : EPAR - All Authorised presentations
  9. EMA 21017 — include: Document linked by EMA product number; content unappraised. Victoza-H-C-1026-PSUV-0029 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
  10. EMA 21758 — include: Document linked by EMA product number; content unappraised. Victoza-H-C-1026-II-0042 : EPAR - Assessment Report - Variation
  11. EMA 22634 — include: Document linked by EMA product number; content unappraised. Xultophy-H-C-PSUSA-00010272-201603 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
  12. EMA 29678 — include: Document linked by EMA product number; content unappraised. Xultophy-PSUSA-00010272-201609 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
  13. EMA 32913 — include: Document linked by EMA product number; content unappraised. Xultophy : EPAR - Risk-management-plan summary
  14. EMA 34192 — include: Document linked by EMA product number; content unappraised. Victoza : EPAR - Medicine overview
  15. EMA 35801 — include: Document linked by EMA product number; content unappraised. Xultophy-H-C-002647-II-0023 : EPAR - Assessment Report - Variation
  16. EMA 36093 — include: Document linked by EMA product number; content unappraised. Victoza-H-C-1026-P46-0029 : EPAR - Assessment Report
  17. EMA 36517 — include: Document linked by EMA product number; content unappraised. Victoza : EPAR - Public assessment report
  18. EMA 36966 — include: Document linked by EMA product number; content unappraised. Victoza : EPAR - All Authorised presentations
  19. EMA 37786 — include: Document linked by EMA product number; content unappraised. Victoza-H-C-1026-PSUSA-00001892- 201512: EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
  20. EMA 38842 — include: Document linked by EMA product number; content unappraised. Saxenda-H-C-3780-P46-016 : EPAR - Assessment Report
  21. EMA 40021 — include: Document linked by EMA product number; content unappraised. Victoza-H-C-1026-II-0023: EPAR - Assessment Report - Variation
  22. EMA 45716 — include: Document linked by EMA product number; content unappraised. Victoza-H-C-1026-II-0049: EPAR - Assessment Report - Variation
  23. EMA 45717 — include: Document linked by EMA product number; content unappraised. Victoza : EPAR - Risk-management-plan summary
  24. EMA 45897 — include: Document linked by EMA product number; content unappraised. Saxenda-H-C-PSUSA-00001892-201812 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
  25. EMA 45901 — include: Document linked by EMA product number; content unappraised. Victoza-H-C-PSUSA-00001892- 201812: EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

EMA search

Local matching in the pinned EMA orphans feed; document matches also use identified EMA product numbers. This is not every national European record.

1 retrieved · 1 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

Case-insensitive word-boundary identity terms: ["Liraglutide", "Saxenda"]

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T08:34:31.262344+00:00 · HTTP 200 · SHA-256 7448bf4e77e3345b3f3fbb7062c335d2302d8ea458a246bbe8256ce48aad2806.

  • Document appraisal and national European sources remain open.
  • Zero matches apply only to these feed fields and terms; orphan designation is not approval.

Showing 1 of 1 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. EMA EU/3/22/2667 — include: EMA orphan feed identifies liraglutide; designation status: Positive. Orphan designation is not marketing authorization.

ClinicalTrials.gov search

ClinicalTrials.gov name/alias discovery, including cited product names. Matches may concern combinations, background references or different formulations; identity and outcomes need screening.

546 retrieved · 0 included · 0 excluded · 546 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

"Liraglutide" OR "Saxenda" OR "Ablymico" OR "Liraglutide STADA" OR "Victoza" OR "Xultophy"

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:26:28.806470+00:00 · HTTP 200 · SHA-256 7c583f99a9a1fa2f59c5726b7ae8c94b6d5384bc2e95251e9666c4ab0e11bc56.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:26:30.145596+00:00 · HTTP 200 · SHA-256 a81c85265b3fda5ba360a2e5987f049db1de25a8982fe163252c318386f6274b.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:26:31.696378+00:00 · HTTP 200 · SHA-256 4617322e80e0498413054690483e80a8106e71079eb5bf0846eea6927779075f.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:26:33.239312+00:00 · HTTP 200 · SHA-256 1ced2233ada1294daa41e84de551bf739649d69b65fdb02ef51f7208abd95667.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:26:34.793608+00:00 · HTTP 200 · SHA-256 b2f941379006d3144d3b02558c4992229f849dda0402eee4309ebaa7741d35a4.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:26:36.160792+00:00 · HTTP 200 · SHA-256 6a792f095eebae791bcb967e55a94748ec56cf115d43ba7467b7f06767b0f66f.

  • Registration is not evidence that a study succeeded, that results were published, or that a use is approved.
  • Other registries, unregistered studies and additional aliases remain outside this query.

Showing 25 of 546 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. ClinicalTrials.gov NCT01595789 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  2. ClinicalTrials.gov NCT01507285 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  3. ClinicalTrials.gov NCT02292290 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  4. ClinicalTrials.gov NCT05479591 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  5. ClinicalTrials.gov NCT01288326 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  6. ClinicalTrials.gov NCT01800968 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  7. ClinicalTrials.gov NCT02863419 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  8. ClinicalTrials.gov NCT02140983 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  9. ClinicalTrials.gov NCT03885297 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  10. ClinicalTrials.gov NCT01508923 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  11. ClinicalTrials.gov NCT00700817 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  12. ClinicalTrials.gov NCT05225974 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  13. ClinicalTrials.gov NCT01845259 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  14. ClinicalTrials.gov NCT01602913 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  15. ClinicalTrials.gov NCT01592279 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  16. ClinicalTrials.gov NCT02777073 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  17. ClinicalTrials.gov NCT03260881 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  18. ClinicalTrials.gov NCT03101930 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  19. ClinicalTrials.gov NCT03555994 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  20. ClinicalTrials.gov NCT01509742 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  21. ClinicalTrials.gov NCT02016846 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  22. ClinicalTrials.gov NCT04034524 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  23. ClinicalTrials.gov NCT05812183 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  24. ClinicalTrials.gov NCT01934816 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
  25. ClinicalTrials.gov NCT01677104 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
Read the full Human Evidence Review

Supervised synthesis

What do selected human studies report about Liraglutide?

Manually reviewed August 19, 2026 · version 1

Browse all Human Evidence Reviews · Open preserved synthesis version 1 →

A bounded review of two sponsor-funded randomized trials: one 56-week weight-management trial and one cardiovascular-outcomes trial in type 2 diabetes.12

Bottom line from this bounded source set

The reviewed weight-management trial reported greater mean weight reduction than placebo, and the reviewed cardiovascular trial reported fewer primary cardiovascular events in a high-risk type 2 diabetes population. The findings remain specific to the studied populations and trial conditions.12

Reviewed study record

SCALE weight-management trial

Design

A double-blind, randomized, placebo-controlled trial assessed body-weight change over 56 weeks alongside lifestyle counseling.1

Population

The trial randomized 3,731 adults without type 2 diabetes who had obesity, or overweight with dyslipidemia or hypertension.1

Outcomes reported

Reported mean weight loss was 8.4 kilograms with liraglutide and 2.8 kilograms with placebo. At least 5% weight loss was reported for 63.2% and 27.1%, respectively, and gastrointestinal events were common.1

Limitations

The sponsor-funded trial combined treatment with lifestyle counseling, excluded type 2 diabetes, and used imputation for the reported mean weight-change analysis.1

Reviewed study record

LEADER cardiovascular-outcomes trial

Design

A double-blind, randomized, placebo-controlled cardiovascular-outcomes trial followed participants for a median of 3.8 years.2

Population

The trial randomized 9,340 adults with type 2 diabetes and high cardiovascular risk in addition to standard care.2

Outcomes reported

The primary composite cardiovascular outcome occurred in 13.0% of the liraglutide group and 14.9% of the placebo group, with a reported hazard ratio of 0.87. Gastrointestinal events were the most common events leading to discontinuation.2

Limitations

The sponsor-funded findings apply to a high-cardiovascular-risk type 2 diabetes population receiving standard care and do not establish the same effect in lower-risk populations.2

Reviewed source set

  1. PubMed · 26132939A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management ↗PubMed PMID 26132939 · EFetch XML reviewed 2026-08-19 · payload SHA-256 5c94f293c86af2a279cfa8ae529f06100cf2dce79b2009b0a6ba26fb9ca9bce6
    No registered Crossref update in the reviewed snapshotChecked August 19, 2026 for DOI 10.1056/nejmoa1411892. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
  2. PubMed · 27295427Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes ↗PubMed PMID 27295427 · EFetch XML reviewed 2026-08-19 · payload SHA-256 d86dca944a90d406ed7a98e6e46eb8d9774504c7746b167351df04f923325e26
    No registered Crossref update in the reviewed snapshotChecked August 19, 2026 for DOI 10.1056/nejmoa1603827. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
Explore status sources, recent additions, and coverage gaps

Living status brief

What is the current status of Liraglutide?

U.S. label record. The cited DailyMed label identifies Liraglutide and contains the product's official indications and warnings. This profile links to the label without restating it as medical guidance.↗

The cited status sources were checked through July 22, 2026. This answer changes only through the profile’s visible version and correction history.

167Dated records55PubMed records79Trial records29Regulatory records

Evidence present

What records are connected here?

Evidence lanes
4
Source years
17
Drugs@FDA applications
13

These are counts in PeptideScanner’s selected public collection, not measures of research quality, medical relevance, safety, or effectiveness.

Coverage gaps

What remains unknown or unsupported?

All four evidence lanes appear in this selected collection, but their presence does not establish completeness, agreement, research quality, safety, effectiveness, approval, availability, or suitability.

PeptideScanner does not infer an answer where the cited records do not provide one. Open the source-linked records below to inspect their scope and limits.

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Explore the Evidence Map and record counts

Evidence Map v1

What kinds of records connect to Liraglutide?

Compare collection coverage →

This map describes PeptideScanner’s selected, source-linked collection. It is not an evidence grade and does not establish research quality, safety, effectiveness, or medical relevance.

167Selected dated records
168Connected citations
17Populated source years2009–2026
4/4Record lanes present
Clinical trials79Open matching records →Literature metadata55Open matching records →Regulatory29Open matching records →Safety4Open matching records →

Registered human studies

Trial composition

15 of 79 selected trial records include at least one phase value; 16 of 79 include a status value in the retained structured contract.

820 public history versions connect to 77 of these trial records across 21 submitted years. Open the record-history collection →

PhasesPhase 4 7Phase 3 3Not applicable 2Phase 1 2Phase 2 1
Status at observationCompleted 12Active, not recruiting 2Recruiting 2

A phase value is unavailable here for 64 selected records; this is not counted as “no phase.”

A status value is unavailable here for 63 selected records; this is not counted as a trial status.

PubMed bibliography

Publication composition

26 of 55 selected PubMed records include attributed title, venue, publication date, and publication-type fields.

Publication typesJournal Article 19Case Reports 7Letter 7Research Support, Non-U.S. Gov't 5Review 3English Abstract 2Randomized Controlled Trial 2Clinical Trial 1Comment 1Comparative Study 1Multicenter Study 1

Bibliography fields unavailable here for 29 selected records; the records remain visible as metadata observations.

Regulatory and publication surfaces

What is structurally connected?

Drugs@FDA applications
13
FDA Federal Register documents
13
DailyMed SPL versions
2
Canonical profile
Published
Profile structured data
Published
Linked dated records
167

Application counts reflect exact reviewed ingredient connections; Federal Register counts reflect exact reviewed peptide-name matches; DailyMed counts reflect listed SPL versions with retained ZIP receipts. “Published” describes this page’s indexing surface, not the state of scientific evidence.

Profile publication history and record counts

Research hub

Explore the Liraglutide evidence record

Open all 167 records →
167Dated records
4Evidence types
167Cited public sources
17Source years

Change ledger

Recently changed for Liraglutide

Open all 169 events →

PeptideScanner change dates and cited source dates stay separate. These entries report collection or version activity, not a ranking of importance.

Record added

ClinicalTrials.gov record NCT04575844

PeptideScanner retained ClinicalTrials.gov record NCT04575844 at 2026-07-30T16:19:36.923Z. Its registry update date was 2026-05-06, and PeptideScanner's reviewed identity mapping was liraglutide.

PeptideScanner change date
September 9, 2026
Cited source date
May 6, 2026
Evidence lane
Clinical trials
Open the cited record →
Cited source
Record added

ClinicalTrials.gov record NCT07225829

PeptideScanner retained ClinicalTrials.gov record NCT07225829 at 2026-08-10T18:10:03.940Z. Its registry update date was 2026-07-27, and PeptideScanner's reviewed identity mapping was liraglutide.

PeptideScanner change date
September 9, 2026
Cited source date
July 27, 2026
Evidence lane
Clinical trials
Open the cited record →
Cited source
Record added

Monitoring Liraglutide Oligomeric Interconversion and Fibril Dissociation through High-Pressure NMR Spectroscopy.

PubMed lists PMID 42708757 in Analytical chemistry as Journal Article, with publication-date metadata of 2026-09-08 (day precision). PeptideScanner associated the retained record with the identity slug liraglutide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.

PeptideScanner change date
September 9, 2026
Cited source date
September 8, 2026
Evidence lane
Literature metadata
Open the cited record →
Cited source

Official-source collections

Source records for Liraglutide

Open the full research atlas →
PubMed55

26 with attributed title, venue, publication-date, and type metadata.

Journal Article (19)Case Reports (7)Letter (7)
  1. Monitoring Liraglutide Oligomeric Interconversion and Fibril Dissociation through High-Pressure NMR Spectroscopy.Analytical chemistry · 2026 Sep 08
  2. Treatment of obesity with liraglutide in bipolar disorder: a case report.Frontiers in psychiatry · 2026 07 30
  3. Development of zein-based nanoparticles for oral co-delivery of insulin and liraglutide and preliminary in vivo evaluation in Danio rerio.International journal of biological macromolecules · 2026 07 13
Explore all selected literature →
ClinicalTrials.gov79

820 public history versions across these dated registry records; status labels apply only to each cited observation.

Recruiting history (379)Completed history (209)Active Not Recruiting history (151)
Current at observation (8)Completed at observation (71)
Obesity (5)PCOS (2)Type 2 Diabetes (2)Phase 4 (7)Phase 3 (3)Completed (12)Active, not recruiting (2)
Liraglutide · Drug (11)liraglutide · Drug (5)Saxenda · Drug (1)
  1. NCT03883412Registry update August 12, 2026 · current at observation
  2. NCT05313529Registry update August 6, 2026 · completed at observation
  3. NCT07225829Registry update July 27, 2026 · current at observation
Explore all selected trial records →Explore all public record history →
Drugs@FDA13

Original-submission application metadata connected by exact reviewed active-ingredient names.

  1. ANDA212972Full FDA chronology · original submission status AP 2026-07-01
  2. ANDA213155Full FDA chronology · original submission status AP 2026-06-15
  3. ANDA212552Full FDA chronology · original submission status AP 2026-03-30
  4. ANDA215245Full FDA chronology · original submission status AP 2026-03-11
  5. ANDA217063Full FDA chronology · original submission status AP 2026-02-24
Explore all selected FDA applications →Explore 61 dated submissions and 94 documents for Liraglutide →
FDA enforcement reports3

Recall-enforcement metadata connected only through exact application numbers already mapped to this reviewed profile.

  1. D-0541-2026Class II · report date 2026-05-27
  2. D-0618-2021Class II · report date 2021-04-21
  3. D-0622-2021Class II · report date 2021-04-21
Explore all exact FDA enforcement reports →

Counts and links describe PeptideScanner’s selected records. They are not rankings and do not establish research quality, safety, effectiveness, or medical relevance.

Evidence types

Coverage by source year

Selected records span March 10, 2009 to September 8, 2026.

Continue exploring

Profiles with overlapping source-year coverage

Open the research atlas →

These links are based only on overlapping years and evidence lanes in PeptideScanner’s selected records. They do not imply that the peptides are medically or scientifically similar.

Leuprolide17 shared source years215 dated records · 4 evidence typesOctreotide17 shared source years160 dated records · 4 evidence typesTeriparatide17 shared source years149 dated records · 3 evidence typesExenatide17 shared source years119 dated records · 3 evidence types

These dates come from selected source records and PubMed metadata. They are not a complete or continuous timeline of research, safety, approval, or effectiveness.

Evidence summary

What the cited records say

The cited DailyMed label identifies Liraglutide and contains the product's official indications and warnings. This profile links to the label without restating it as medical guidance.↗

This is a source summary, not a medical recommendation. Status may differ by jurisdiction and product.

Cited context

Related records

Organizations named in cited records

  • U.S. National Library of Medicine↗

Dated source history

Updates connected to this profile

Open the full cross-source timeline →

  1. Literature metadata

    Monitoring Liraglutide Oligomeric Interconversion and Fibril Dissociation through High-Pressure NMR Spectroscopy.↗

    PubMed lists PMID 42708757 in Analytical chemistry as Journal Article, with publication-date metadata of 2026-09-08 (day precision). PeptideScanner associated the retained record with the identity slug liraglutide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗

  2. Literature metadata

    Treatment of obesity with liraglutide in bipolar disorder: a case report.↗

    PubMed lists PMID 42597211 in Frontiers in psychiatry as Case Reports, Journal Article, with publication-date metadata of 2026-07-30 (day precision). PeptideScanner associated the retained record with the identity slug liraglutide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗

  3. Literature metadata

    Application of the OBIMAP (One-Bead Interchain Multipeptide Assembly Platform) to Long Peptide Synthesis: Liraglutide as a Case Study.↗

    PubMed lists PMID 41970854 in ACS omega as Journal Article, with publication-date metadata of 2026-03-25 (day precision). PeptideScanner associated the retained record with the identity slug liraglutide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗

  4. Clinical trials

    ClinicalTrials.gov record NCT03883412↗

    PeptideScanner retained ClinicalTrials.gov record NCT03883412 at 2026-08-13T05:54:14.859Z. Its registry update date was 2026-08-12, and PeptideScanner's reviewed identity mapping was liraglutide.↗

  5. Literature metadata

    PubMed record PMID 38240127↗

    PeptideScanner retained PubMed bibliographic metadata for PMID 38240127 at 2026-08-10T10:49:06.873Z. PubMed recorded a metadata revision date of 2026-08-07 and an Entrez history date of 2024-01-19. PeptideScanner associated this retained record with the identity slug liraglutide. These dates describe PubMed metadata history, not the article's original publication date.↗

  6. Clinical trials

    ClinicalTrials.gov record NCT05313529↗

    PeptideScanner retained ClinicalTrials.gov record NCT05313529 at 2026-08-13T05:52:27.020Z. Its registry update date was 2026-08-06, and PeptideScanner's reviewed identity mapping was liraglutide.↗

  7. Literature metadata

    PubMed record PMID 40429612↗

    PeptideScanner retained PubMed bibliographic metadata for PMID 40429612 at 2026-08-10T10:49:06.946Z. PubMed recorded a metadata revision date of 2026-08-06 and an Entrez history date of 2025-05-28. PeptideScanner associated this retained record with the identity slug liraglutide. These dates describe PubMed metadata history, not the article's original publication date.↗

  8. Literature metadata

    PubMed record PMID 40913889↗

    PeptideScanner retained PubMed bibliographic metadata for PMID 40913889 at 2026-08-10T10:49:06.966Z. PubMed recorded a metadata revision date of 2026-08-06 and an Entrez history date of 2025-09-06. PeptideScanner associated this retained record with the identity slug liraglutide. These dates describe PubMed metadata history, not the article's original publication date.↗

  9. Literature metadata

    PubMed record PMID 41321175↗

    PeptideScanner retained PubMed bibliographic metadata for PMID 41321175 at 2026-08-10T10:49:07.012Z. PubMed recorded a metadata revision date of 2026-08-06 and an Entrez history date of 2025-12-01. PeptideScanner associated this retained record with the identity slug liraglutide. These dates describe PubMed metadata history, not the article's original publication date.↗

  10. Literature metadata

    PubMed record PMID 42549609↗

    PeptideScanner retained PubMed bibliographic metadata for PMID 42549609 at 2026-08-10T10:49:12.984Z. PubMed recorded a metadata revision date of 2026-08-06 and an Entrez history date of 2026-08-04. PeptideScanner associated this retained record with the identity slug liraglutide. These dates describe PubMed metadata history, not the article's original publication date.↗

  11. Literature metadata

    PubMed record PMID 38092710↗

    PeptideScanner retained PubMed bibliographic metadata for PMID 38092710 at 2026-08-10T10:49:06.858Z. PubMed recorded a metadata revision date of 2026-08-05 and an Entrez history date of 2023-12-13. PeptideScanner associated this retained record with the identity slug liraglutide. These dates describe PubMed metadata history, not the article's original publication date.↗

  12. Literature metadata

    PubMed record PMID 41651380↗

    PeptideScanner retained PubMed bibliographic metadata for PMID 41651380 at 2026-08-10T10:49:08.761Z. PubMed recorded a metadata revision date of 2026-08-04 and an Entrez history date of 2026-02-06. PeptideScanner associated this retained record with the identity slug liraglutide. These dates describe PubMed metadata history, not the article's original publication date.↗

Public beta · Selective source coverageNot medical advice · No dosing or purchasing guidance