Related names in cited records: IBI362, LY3305677↗
A June 2025 Suzhou Industrial Park regulator report describes Chinese approval of mazdutide injection for long-term weight management in adults with obesity or overweight. A December 2025 Suzhou government report describes approved diabetes and weight-management indications in China.↗↗
Citation markers ↗ open the public records supporting the adjacent statements.
Correction · September 15, 2026
The previous profile used an unqualified investigational status. We added dated local-government reports of approval in China while keeping national decision and label verification open. Earlier trial-based versions remain available. 23
China: approval reported by local government sources. These are attributable local-government reports, not the national approval decision or complete prescribing information. The national decision and exact indication conditions remain to be reconciled. This account does not establish approval in the United States or other jurisdictions.↗↗
Review source snapshots checked September 15, 2026 · Integrity checked September 15, 2026.
Four selected trials examine mazdutide in adults with obesity or type 2 diabetes in China and the United States. Trial populations, comparators and statistical estimands differ and should not be used to rank results across studies.↗↗↗↗
What the reviewed sources report
Randomized trials reported weight and glucose-control improvements in the studied populations, with gastrointestinal adverse events. These publications do not by themselves establish regulatory status, long-term complications or comparative effectiveness outside their specific designs.↗↗↗↗
What remains unresolved?
How do dated regulatory decisions differ by jurisdiction and indication?↗↗↗↗
What do full reports establish about missing outcomes, uncommon harms and durability?↗↗↗↗
NCT04904913 describes a 328-participant Chinese study of IBI362 with a 24-week weight endpoint. NCT06124807 describes a separate 179-participant LY3305677 study with a 32-week primary endpoint and 48-week follow-up. Their results are not interchangeable. NCT04904913 ↗NCT06124807 ↗
More findings and the sources behind them
Selected sponsor-submitted ClinicalTrials.gov records retrieved September 19, 2026, with design, population, endpoint and result-availability checks. This does not complete a registry search or replace primary-publication appraisal.
The later record includes posted weight results
The LY3305677 registry reports modeled mean weight changes of −7.33%, −15.6% and −18.1% across the three active groups versus −0.85% for placebo at week 32. These are changes from baseline in that study, not placebo-adjusted percentages or a cross-drug ranking. NCT06124807 ↗
Longer follow-up involved attrition
The same registry lists 179 participants starting and 128 completing the study. Its repeated-measures estimates should not be mistaken for measurements observed in every participant at every visit; adverse events were among several discontinuation reasons. NCT06124807 ↗
Result availability differs between the two records
The retrieved Chinese phase 2 record has no posted summary-results section, while the LY3305677 record does. Neither registry entry alone establishes the current authorization status in any jurisdiction. NCT04904913 ↗NCT06124807 ↗
What remains to be checked
Reconcile Chinese and international trial families and current jurisdiction-specific regulatory documents.
Appraise original publications and analysis plans, including missing-data assumptions and safety outcomes.
Source dates and review coverage
PDF citations use file page numbers. Named webpage sections and registry fields identify the portions read. These are selected readings, not complete source coverage.
Search and screening record checked 2026-09-15. Counts describe records, not independent trials. Full-text appraisal is separate from an abstract review.
Scoped identity/name search for initial human evidence synthesis; other aliases and preclinical, extension and combination reports require separate eligibility decisions.
51 retrieved · 4 included · 0 excluded · 47 awaiting a decision · 0 full-text appraisals
Search terms, record decisions and remaining work
"mazdutide"[Title/Abstract] OR "IBI362"[Title/Abstract] OR "LY3305677"[Title/Abstract]
Full-text appraisal and screening of unassessed records remain open.
Registry comparison, additional aliases and references, and regulator reconciliation require separate checks.
Showing 25 of 51 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
PubMed 42628555 — include: Selected human report; abstract and record metadata reviewed. Study families: NCT06124807.
PubMed 41407860 — include: Selected human report; abstract and record metadata reviewed. Study families: NCT05606913.
PubMed 41407859 — include: Selected human report; abstract and record metadata reviewed. Study families: mazdutide-PMID41407859-registry-linkage-unresolved.
PubMed 40421736 — include: Selected human report; abstract and record metadata reviewed. Study families: NCT05607680.
PubMed 42603384 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42410325 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42688617 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42555719 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42535526 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42251768 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42251596 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42251595 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42208956 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42419792 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41948476 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41804840 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41875890 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41820018 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41054801 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41787737 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41901218 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41711462 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41710707 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41389801 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41478576 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
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.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
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 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
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.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Document appraisal and national European sources remain open.
Zero matches apply only to these feed fields and terms; orphan designation is not approval.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
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.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Document appraisal and national European sources remain open.
Zero matches apply only to these feed fields and terms; orphan designation is not approval.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
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.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Document appraisal and national European sources remain open.
Zero matches apply only to these feed fields and terms; orphan designation is not approval.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
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.
45 retrieved · 0 included · 0 excluded · 45 awaiting a decision · 0 full-text appraisals
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 45 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
ClinicalTrials.gov NCT05793450 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT06817356 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07255209 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT06184568 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07713992 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT06937749 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07135141 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT06124807 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT02972645 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT04773977 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT05815680 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT04904913 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07797101 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT04466904 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07718126 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07517042 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07803705 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07000955 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT06931028 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07657676 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07781150 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT06884293 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07767552 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT05606913 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07809945 — 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 Mazdutide?
Four selected trials examine mazdutide in adults with obesity or type 2 diabetes in China and the United States. Trial populations, comparators and statistical estimands differ and should not be used to rank results across studies.1234
Bottom line from this bounded source set
Randomized trials reported weight and glucose-control improvements in the studied populations, with gastrointestinal adverse events. These publications do not by themselves establish regulatory status, long-term complications or comparative effectiveness outside their specific designs.1234
610 adults with overweight or obesity participated.1
Outcomes reported
At week 32, intention-to-treat weight changes were −10.09% and −12.55% in active groups versus +0.45% with placebo. Gastrointestinal adverse events were common; adverse-event discontinuation occurred in 1.5%, 0.5% and 1.0%, respectively.1
Limitations
The study concerns its enrolled population and prespecified follow-up. Weight change alone cannot establish cardiovascular benefit or longer-term safety.1
Reviewed study record
Type 2 diabetes: active comparator
Design
Randomized phase 3 comparison with a specified dulaglutide regimen over 28 weeks.2
Population
731 adults in China with type 2 diabetes participated.2
Outcomes reported
Between-group HbA1c differences favored the two mazdutide groups by 0.24 and 0.30 percentage points; reductions in percentage body-weight change were 3.78 and 5.76 percentage points greater than with dulaglutide. Gastrointestinal events were more frequent with mazdutide.2
Limitations
The comparison is specific to the tested regimens and population, not a ranking against all uses of the comparator or other medicines.2
Reviewed study record
Type 2 diabetes: placebo comparison
Design
Randomized, double-blind phase 3 trial with a 24-week primary comparison.3
Population
320 adults in China with type 2 diabetes participated.3
Outcomes reported
HbA1c changes were −1.57 and −2.15 percentage points versus −0.14 with placebo. Gastrointestinal events were common.3
Limitations
The subsequent extension is follow-up of this study, not a separate randomized experiment. Biomarker changes do not establish reduced complications.3
Reviewed study record
US phase 2 obesity trial
Design
Randomized, placebo-controlled phase 2 trial with a week-32 primary endpoint and longer follow-up.4
Population
179 adults with overweight or obesity participated.4
Outcomes reported
The reported hypothetical-estimand weight changes at week 32 were −7.3%, −15.6% and −18.1% versus −0.9%. Adverse events led to discontinuation in 20% of the highest active group.4
Limitations
A hypothetical estimand is not the same as observed outcomes regardless of discontinuation. Population, follow-up and estimand differences prevent direct comparison with GLORY-1.4
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1056/nejmoa2411528. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1038/s41586-025-10031-z. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1038/s41586-025-10026-w. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1016/s2213-8587(26)00160-9. 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 Mazdutide?
China: approval reported by local government sources. These are attributable local-government reports, not the national approval decision or complete prescribing information. The national decision and exact indication conditions remain to be reconciled. This account does not establish approval in the United States or other jurisdictions.↗↗
The cited status sources were checked through September 15, 2026. This answer changes only through the profile’s visible version and correction history.
PeptideScanner currently has no selected regulatory records and safety records connected to this profile. That is a collection gap, not evidence that no such records exist.
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.
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.
Status at observationCompleted 2Not yet recruiting 2Recruiting 2
A phase value is unavailable here for 4 selected records; this is not counted as “no phase.”
A status value is unavailable here for 4 selected records; this is not counted as a trial status.
PubMed bibliography
Publication composition
0 of 5 selected PubMed records include attributed title, venue, publication date, and publication-type fields.
Bibliography fields unavailable here for 5 selected records; the records remain visible as metadata observations.
Regulatory and publication surfaces
What is structurally connected?
Drugs@FDA applications
0
FDA Federal Register documents
0
DailyMed SPL versions
0
Canonical profile
Published
Profile structured data
Published
Linked dated records
15
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.
The previous profile used an unqualified investigational status. We added dated local-government reports of approval in China while keeping national decision and label verification open. Earlier trial-based versions remain available.
PeptideScanner retained ClinicalTrials.gov record NCT07083154 at 2026-09-09T19:17:17.091Z. Its registry update date was 2026-09-02, and PeptideScanner's reviewed identity mapping was mazdutide.
PeptideScanner retained ClinicalTrials.gov record NCT07803705 at 2026-09-09T19:17:17.113Z. Its registry update date was 2026-09-04, and PeptideScanner's reviewed identity mapping was mazdutide.
Counts and links describe PeptideScanner’s selected records. They are not rankings and do not establish research quality, safety, effectiveness, or medical relevance.
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.
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
These are attributable local-government reports, not the national approval decision or complete prescribing information. The national decision and exact indication conditions remain to be reconciled. This account does not establish approval in the United States or other jurisdictions.↗↗
This is a source summary, not a medical recommendation. Status may differ by jurisdiction and product.
PeptideScanner retained ClinicalTrials.gov record NCT07803705 at 2026-09-09T19:17:17.113Z. Its registry update date was 2026-09-04, and PeptideScanner's reviewed identity mapping was mazdutide.↗
PeptideScanner retained ClinicalTrials.gov record NCT07083154 at 2026-09-09T19:17:17.091Z. Its registry update date was 2026-09-02, and PeptideScanner's reviewed identity mapping was mazdutide.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 42251596 at 2026-08-10T10:49:10.669Z. PubMed recorded a metadata revision date of 2026-08-04 and an Entrez history date of 2026-06-07. PeptideScanner associated this retained record with the identity slug mazdutide. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained ClinicalTrials.gov record NCT07718126 at 2026-08-10T18:10:03.957Z. Its registry update date was 2026-07-21, and PeptideScanner's reviewed identity mapping was mazdutide.↗
PeptideScanner retained ClinicalTrials.gov record NCT06817356 at 2026-08-10T18:10:03.951Z. Its registry update date was 2026-07-16, and PeptideScanner's reviewed identity mapping was mazdutide.↗
PeptideScanner retained ClinicalTrials.gov record NCT07657676 at 2026-07-30T16:19:03.062Z. Its registry update date was 2026-06-18, and PeptideScanner's reviewed identity mapping was mazdutide.↗
PeptideScanner retained ClinicalTrials.gov record NCT07654062 at 2026-07-30T16:19:03.055Z. Its registry update date was 2026-06-17, and PeptideScanner's reviewed identity mapping was mazdutide.↗
PeptideScanner retained ClinicalTrials.gov record NCT07469800 at 2026-07-30T16:19:36.903Z. Its registry update date was 2026-05-27, and PeptideScanner's reviewed identity mapping was mazdutide.↗
PeptideScanner retained ClinicalTrials.gov record NCT06124807 at 2026-07-30T16:20:49.321Z. Its registry update date was 2026-04-21, and PeptideScanner's reviewed identity mapping was mazdutide.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 41901218 at 2026-07-30T16:23:42.462Z. PubMed recorded a metadata revision date of 2026-03-30 and an Entrez history date of 2026-03-28. PeptideScanner associated this retained record with the identity slug mazdutide. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 40929642 at 2026-07-30T18:22:54.035Z. PubMed recorded a metadata revision date of 2025-09-10 and an Entrez history date of 2025-09-10. PeptideScanner associated this retained record with the identity slug mazdutide. These dates describe PubMed metadata history, not the article's original publication date.↗