Maridebart cafraglutide^↗

"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.

1. 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.
2. 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.

   Read the source full text (Europe PMC XML) ↗ · NCT04478708 registry record ↗

   Randomization and masking

   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.

   Reviewed 2026-09-15; source SHA-256 478426a0d5db2904b80277b75c031bfc0e86e4d615de08b17435270cb227511c.

3. PubMed 42492687 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.
4. PubMed 42166683 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.
5. PubMed 42568490 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.
6. PubMed 42592044 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.
7. PubMed 41948476 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.
8. PubMed 42198313 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.
9. PubMed 41941715 — exclude: Preclinical, genetic or mechanistic study; no primary administration of this molecule to people is reported in the inspected abstract.
10. PubMed 41054801 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.
11. PubMed 41287212 — exclude: Preclinical, genetic or mechanistic study; no primary administration of this molecule to people is reported in the inspected abstract.
12. PubMed 41337724 — exclude: PubMed identifies a Letter/Comment on PMID40549887, not a separate primary trial report. Correspondence content remains a follow-up interpretation source.
13. PubMed 41337723 — exclude: PubMed identifies a Letter/Comment on PMID40549887, not a separate primary trial report. Correspondence content remains a follow-up interpretation source.
14. PubMed 41337722 — exclude: PubMed identifies a Letter/Comment on PMID40549887, not a separate primary trial report. Correspondence content remains a follow-up interpretation source.
15. PubMed 41093047 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.
16. PubMed 40507574 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.
17. PubMed 40081498 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.
18. PubMed 39723966 — exclude: Preclinical, genetic or mechanistic study; no primary administration of this molecule to people is reported in the inspected abstract.
19. PubMed 38843460 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.
20. PubMed 38871982 — exclude: Preclinical, genetic or mechanistic study; no primary administration of this molecule to people is reported in the inspected abstract.
21. PubMed 38763780 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.
22. 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.

    Eligibility source ↗ · Article classification: Research Highlight; original-article reference · read 2026-09-15.

23. PubMed 36509857 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.
24. PubMed 36608818 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.
25. PubMed 34176426 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.

products.active_ingredients.name:"MARIDEBART CAFRAGLUTIDE"

• 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.

Case-insensitive word-boundary identity terms: ["Maridebart cafraglutide", "MariTide", "AMG 133"]

• 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.

Case-insensitive word-boundary identity terms: ["Maridebart cafraglutide", "MariTide", "AMG 133"]

• 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.

1. 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)
2. 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

Case-insensitive word-boundary identity terms: ["Maridebart cafraglutide", "MariTide", "AMG 133"]

• 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.

"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.

1. ClinicalTrials.gov NCT06858878 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
2. ClinicalTrials.gov NCT07313761 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
3. ClinicalTrials.gov NCT07429032 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
4. ClinicalTrials.gov NCT06987695 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
5. ClinicalTrials.gov NCT07523711 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
6. ClinicalTrials.gov NCT07037433 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
7. ClinicalTrials.gov NCT07441252 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
8. ClinicalTrials.gov NCT07160257 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
9. ClinicalTrials.gov NCT07428525 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
10. ClinicalTrials.gov NCT07226778 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
11. ClinicalTrials.gov NCT07684235 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
12. ClinicalTrials.gov NCT07684144 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
13. ClinicalTrials.gov NCT07717814 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
14. ClinicalTrials.gov NCT06858839 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
15. ClinicalTrials.gov NCT07229157 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
16. ClinicalTrials.gov NCT05056246 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
17. ClinicalTrials.gov NCT07429045 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
18. ClinicalTrials.gov NCT07310563 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
19. ClinicalTrials.gov NCT06660173 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
20. ClinicalTrials.gov NCT05669599 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
21. ClinicalTrials.gov NCT07226765 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
22. ClinicalTrials.gov NCT04478708 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
23. ClinicalTrials.gov NCT07575399 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
24. ClinicalTrials.gov NCT06976372 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
25. ClinicalTrials.gov NCT06352892 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.