Review source snapshots checked September 15, 2026 · Integrity checked September 15, 2026.
Two selected reports describe early development and a phase 2 trial of an antibody–peptide conjugate combining GIP-receptor antagonism with GLP-1-receptor agonism. Animal experiments and human trial results are separate evidence.↗↗
What the reviewed sources report
The phase 2 trial reported greater weight reduction than placebo over 52 weeks in participants with obesity, with or without type 2 diabetes. Gastrointestinal events were common. These results do not establish long-term clinical outcomes or an approved indication.↗↗
What remains unresolved?
What do full trial reports establish about attrition, estimands and discontinuation?↗↗
What do subsequent trials and jurisdiction-specific agency records establish?↗↗
Although NCT04478708 has an overall masked-trial designation, its participant-flow description says parts A and B were randomized and blinded while part C was open-label. Treating every participant as part of the same blinded comparison would misdescribe the evidence. NCT04478708 ↗
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.
Posted phase 1 results emphasize exposure and safety
The completed 110-participant phase 1 record posts pharmacokinetic, adverse-event and antibody outcomes. Its results table does not contain a body-weight outcome, so a published weight estimate requires its separate source and analysis context. NCT04478708 ↗
The phase 2 study asks a longer-term weight question
NCT05669599 records 592 participants across cohorts with and without type 2 diabetes. The registered primary endpoint is percentage body-weight change at week 52; the total enrollment is not a single outcome-analysis denominator. NCT05669599 ↗
The larger trial lacks posted registry results in this snapshot
The phase 2 record is marked completed, with a January 20, 2026 last-posted update, but no summary-results section in the retrieved payload. That does not invalidate or replace separately published clinical reports. NCT05669599 ↗
What remains to be checked
Appraise the phase 1 and phase 2 publications, including weight outcomes absent from these registry results.
Reconcile longer follow-up and adverse-event reporting across blinded and open-label parts.
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.
25 retrieved · 2 included · 23 excluded · 0 awaiting a decision · 1 full-text appraisals
Search terms, record decisions and remaining work
"maridebart cafraglutide"[Title/Abstract] OR "AMG 133"[Title/Abstract] OR "maritide"[Title/Abstract]
Registry comparison, additional aliases and references, and regulator reconciliation require separate checks.
Correspondence PMIDs 41337722, 41337723 and 41337724 concerns the phase 2 report; its interpretive implications remain unappraised. These are not counted as separate trials.
The phase 1 main article has a structured reading; its November 2024 replacement source-data files and supplements remain unreconciled. The phase 2 primary report still needs full-text appraisal.
Showing 25 of 25 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
PubMed 40549887 — include: Primary human trial or extension report; the selected abstract establishes the trial identity, while full-text appraisal and registry history remain separate. Study families: NCT05669599.
PubMed 38316982 — include: The main full text and current registry outcomes were read. The appraisal retains cohort-selection, missing-data and corrected source-file limitations; supplements and historical registration remain open. Study families: NCT04478708.Structured full-text reading · PMC10896721
This is an editorial structured reading, not a validated risk-of-bias score.
The phase 1 study reports double-blind 3:1 randomization against matching-volume saline placebo. Sequential cohorts used sentinel safety review. Allocation-concealment details and the linked protocol have not been independently reconciled.
Missing data
The paper reports 75 participants from a 110-person program, excluding intravenous, digital-tool and open-label escalation cohorts. Four participants in the highest multiple-dose cohort withdrew before their second dose after mild gastrointestinal events. Missing data were not imputed, so later observed weight changes must not be read as outcomes for everyone enrolled. The safety section nevertheless reports no events leading to permanent discontinuation; that wording has not been reconciled with the withdrawal account.
Outcome selection
Safety was primary, pharmacokinetics secondary and weight change exploratory. The study had no hypothesis-driven power calculation; reported t-tests were post hoc. A November 19, 2024 change-history note says incorrect source-data files were replaced. The replaced files and their numerical impact have not been independently reconciled.
Applicability
This small US phase 1 population had obesity without diabetes and excluded important laboratory abnormalities. There was no active comparator. It cannot establish long-term benefit, uncommon harms or the separate contributions of the two receptor actions.
Funding and conflicts
Amgen funded the study and participated in design, data collection, analysis, interpretation and publication. Most authors were current or former Amgen employees and stockholders; these relationships matter when interpreting exploratory findings.
Registry comparison
The current NCT04478708 record lists 110 enrolled participants, safety as primary and pharmacokinetic outcomes as secondary, consistent with the broader program. The paper reports a 75-person subset. The registry also lists immunogenicity as secondary. Historical outcome versions, the full results tables, protocol and analysis plan remain to be reconciled.
PubMed 42492687 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.
PubMed 42166683 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.
PubMed 42568490 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.
PubMed 42592044 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.
PubMed 41948476 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.
PubMed 42198313 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.
PubMed 41941715 — exclude: Preclinical, genetic or mechanistic study; no primary administration of this molecule to people is reported in the inspected abstract.
PubMed 41054801 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.
PubMed 41287212 — exclude: Preclinical, genetic or mechanistic study; no primary administration of this molecule to people is reported in the inspected abstract.
PubMed 41337724 — exclude: PubMed identifies a Letter/Comment on PMID40549887, not a separate primary trial report. Correspondence content remains a follow-up interpretation source.
PubMed 41337723 — exclude: PubMed identifies a Letter/Comment on PMID40549887, not a separate primary trial report. Correspondence content remains a follow-up interpretation source.
PubMed 41337722 — exclude: PubMed identifies a Letter/Comment on PMID40549887, not a separate primary trial report. Correspondence content remains a follow-up interpretation source.
PubMed 41093047 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.
PubMed 40507574 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.
PubMed 40081498 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.
PubMed 39723966 — exclude: Preclinical, genetic or mechanistic study; no primary administration of this molecule to people is reported in the inspected abstract.
PubMed 38843460 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.
PubMed 38871982 — exclude: Preclinical, genetic or mechanistic study; no primary administration of this molecule to people is reported in the inspected abstract.
PubMed 38763780 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.
PubMed 38388678 — exclude: The publisher identifies this item as a Research Highlight and links the original AMG 133 study. It is secondary coverage, not another primary human-administration report.
PubMed 36509857 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.
PubMed 36608818 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.
PubMed 34176426 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.
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.
2 retrieved · 0 included · 0 excluded · 2 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 2 of 2 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
EMA 68677 — not screened: Title-name match awaiting identity and document review. P/0131/2024: EMA decision of 11 April 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for GIPR antagonist/GLP-1R agonist (AMG 133) (EMEA-003439-PIP02-23)
EMA 74476 — not screened: Title-name match awaiting identity and document review. EMA/PE/0000239753 : EMA decision of 24 April 2025 on the granting of a product specific waiver for maridebart cafraglutide
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.
27 retrieved · 0 included · 0 excluded · 27 awaiting a decision · 0 full-text appraisals
Search terms, record decisions and remaining work
"Maridebart cafraglutide" OR "MariTide" OR "AMG 133"
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 27 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
ClinicalTrials.gov NCT06858878 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07313761 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07429032 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT06987695 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07523711 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07037433 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07441252 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07160257 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07428525 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07226778 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07684235 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07684144 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07717814 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT06858839 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07229157 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT05056246 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07429045 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07310563 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT06660173 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT05669599 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07226765 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT04478708 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07575399 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT06976372 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT06352892 — 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 Maridebart cafraglutide?
Two selected reports describe early development and a phase 2 trial of an antibody–peptide conjugate combining GIP-receptor antagonism with GLP-1-receptor agonism. Animal experiments and human trial results are separate evidence.12
Bottom line from this bounded source set
The phase 2 trial reported greater weight reduction than placebo over 52 weeks in participants with obesity, with or without type 2 diabetes. Gastrointestinal events were common. These results do not establish long-term clinical outcomes or an approved indication.12
Reviewed study record
Early translational and human program
Design
The publication combines preclinical experiments with an early randomized clinical trial.1
Population
The human trial enrolled people with obesity; animal findings in the same report are not human outcomes.1
Outcomes reported
The authors reported weight reductions in the early human program alongside pharmacologic and preclinical findings.1
Limitations
The abstract does not support a complete participant-flow or harms appraisal. Early exploratory findings cannot establish durable clinical benefit, and the conjugate is not interchangeable with other peptides.1
Reviewed study record
Phase 2 obesity trial
Design
Randomized, placebo-controlled 52-week trial with multiple active groups; NCT05669599.2
Population
592 participants: 465 with obesity without diabetes and 127 with obesity and type 2 diabetes.2
Outcomes reported
In the intention-to-treat analysis, weight changes ranged from −12.3% to −16.2% versus −2.5% without diabetes, and −8.4% to −12.3% versus −1.7% with diabetes. Gastrointestinal events were common.2
Limitations
Multiple groups and two populations should not be pooled into a single effect. Weight is not a direct measure of cardiovascular outcomes, and longer-term safety remains unresolved.2
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1038/s42255-023-00966-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 10.1056/nejmoa2504214. 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 Maridebart cafraglutide?
Investigational. ClinicalTrials.gov lists an Amgen bioavailability study as completed, updated July 21, 2026.↗
The cited status sources were checked through July 22, 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.
A phase value is unavailable here for 6 selected records; this is not counted as “no phase.”
A status value is unavailable here for 6 selected records; this is not counted as a trial status.
PubMed bibliography
Publication composition
1 of 4 selected PubMed records include attributed title, venue, publication date, and publication-type fields.
Publication typesJournal Article 1Review 1
Bibliography fields unavailable here for 3 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
16
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 Maridebart cafraglutide evidence record
PeptideScanner retained ClinicalTrials.gov record NCT07575399 at 2026-09-09T19:17:17.083Z. Its registry update date was 2026-08-27, and PeptideScanner's reviewed identity mapping was maridebart-cafraglutide.
PeptideScanner retained ClinicalTrials.gov record NCT07684144 at 2026-09-09T19:17:17.403Z. Its registry update date was 2026-09-03, and PeptideScanner's reviewed identity mapping was maridebart-cafraglutide.
PeptideScanner retained ClinicalTrials.gov record NCT07313761 at 2026-08-13T05:52:27.026Z. Its registry update date was 2026-08-07, and PeptideScanner's reviewed identity mapping was maridebart-cafraglutide.
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
ClinicalTrials.gov lists an Amgen bioavailability study as completed, updated July 21, 2026.↗
This is a source summary, not a medical recommendation. Status may differ by jurisdiction and product.
PeptideScanner retained ClinicalTrials.gov record NCT07684144 at 2026-09-09T19:17:17.403Z. Its registry update date was 2026-09-03, and PeptideScanner's reviewed identity mapping was maridebart-cafraglutide.↗
PeptideScanner retained ClinicalTrials.gov record NCT07575399 at 2026-09-09T19:17:17.083Z. Its registry update date was 2026-08-27, and PeptideScanner's reviewed identity mapping was maridebart-cafraglutide.↗
PubMed lists PMID 42592044 in Antibody therapeutics as Journal Article, Review, with publication-date metadata of 2026-06-01 (day precision). PeptideScanner associated the retained record with the identity slug maridebart-cafraglutide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PeptideScanner retained ClinicalTrials.gov record NCT07313761 at 2026-08-13T05:52:27.026Z. Its registry update date was 2026-08-07, and PeptideScanner's reviewed identity mapping was maridebart-cafraglutide.↗
PeptideScanner retained ClinicalTrials.gov record NCT07684235 at 2026-08-13T05:52:27.017Z. Its registry update date was 2026-08-04, and PeptideScanner's reviewed identity mapping was maridebart-cafraglutide.↗
PeptideScanner retained ClinicalTrials.gov record NCT07037433 at 2026-08-10T18:10:03.862Z. Its registry update date was 2026-07-24, and PeptideScanner's reviewed identity mapping was maridebart-cafraglutide.↗
PeptideScanner retained ClinicalTrials.gov record NCT07037459 at 2026-08-10T18:10:04.222Z. Its registry update date was 2026-07-02, and PeptideScanner's reviewed identity mapping was maridebart-cafraglutide.↗
PeptideScanner retained ClinicalTrials.gov record NCT07441252 at 2026-07-30T16:19:03.063Z. Its registry update date was 2026-06-18, and PeptideScanner's reviewed identity mapping was maridebart-cafraglutide.↗
PeptideScanner retained ClinicalTrials.gov record NCT07226765 at 2026-07-30T16:19:03.046Z. Its registry update date was 2026-06-12, and PeptideScanner's reviewed identity mapping was maridebart-cafraglutide.↗
PeptideScanner retained ClinicalTrials.gov record NCT07225686 at 2026-07-30T16:19:03.064Z. Its registry update date was 2026-06-12, and PeptideScanner's reviewed identity mapping was maridebart-cafraglutide.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 41337722 at 2026-07-30T16:23:39.188Z. PubMed recorded a metadata revision date of 2026-03-04 and an Entrez history date of 2025-12-03. PeptideScanner associated this retained record with the identity slug maridebart-cafraglutide. These dates describe PubMed metadata history, not the article's original publication date.↗