Maridebart cafraglutide / Overweight and Obesity · Phase 1 Trial

A Trial to Compare the Extent to Which Maridebart Cafraglutide (AMG 133) is Made Available in the Body When Administered Using Two Subcutaneous Presentations

ClinicalTrials.gov · August 7, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 1 pharmacokinetic study comparing bioavailability of maridebart cafraglutide administered via two subcutaneous formulations in 349 participants with overweight or obesity. The trial has completed recruitment, but results have not been posted to this registry record and therefore cannot be evaluated.

What was studied

Phase 1, Interventional, Randomized, Parallel, Open label, Treatment purpose. Overweight and Obesity; age from 18 Years; to 60 Years. Intervention: Maridebart Cafraglutide SC Presentation 1. Compared with: Maridebart Cafraglutide SC Presentation 2 — Active Comparator. n = 349. 4 sites: United States.

Key findings

Safety

Endpoints are pharmacokinetic surrogates; clinical outcomes not yet available.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

Phase 1 pharmacokinetic study of a new drug formulation in a completed trial; results not yet reported in this registry record.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Infinity (AUCinf) of AMG 133 (assessed at Up to Day 120); AUC From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of AMG 133 (assessed at Up to Day 120); Maximum Observed Plasma Concentration (Cmax) of AMG 133 (assessed at Up to Day 120)

DesignPhase 1, Interventional, Randomized, Parallel, Open label, Treatment purpose

PopulationOverweight and Obesity; age from 18 Years; to 60 Years

Sample size349

InterventionMaridebart Cafraglutide SC Presentation 1

ComparatorMaridebart Cafraglutide SC Presentation 2 — Active Comparator

Setting4 sites: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment349

PhasePhase 1

Primary outcome measure 1AUCinf of AMG 133, up to Day 120

Primary outcome measure 2AUClast of AMG 133, up to Day 120

Primary outcome measure 3Cmax of AMG 133, up to Day 120

Caveats

This registry record reports planned study design only; no results are posted and efficacy or clinical benefit cannot be assessed.
Endpoints are pharmacokinetic surrogates; clinical outcomes not yet available.
No information on study conduct, blinding, randomization method, or participant allocation provided in registry record.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 1 PK comparison of two subcutaneous presentations; interventional design appropriate for PK assessment.

Directness

limited

Pharmacokinetic endpoints (AUC, Cmax) are surrogate measures; clinical efficacy not addressed.

Consistency

insufficient

Registry record only; no results reported for comparison with other data.

Risk of bias

insufficient

No details on blinding, allocation concealment, or conduct reported in registry record.

Sample adequacy

moderate

349 participants enrolled; adequate for Phase 1 PK study but enrollment strategy not described.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07313761). This is a study registration, not published results. Lead sponsor: Amgen. Recruitment status: COMPLETED. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 349 participants (ACTUAL). Conditions: Overweight and Obesity. Interventions: DRUG: Maridebart Cafraglutide. Primary outcome measures: Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Infinity (AUCinf) of AMG 133 , Up to Day 120; AUC From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of AMG 133 , Up to Day 120; Maximum Observed Plasma Concentration (Cmax) of AMG 133 , Up to Day 120. Brief summary: The main objective of this trial is to evaluate the pharmacokinetics (PK) of maridebart cafraglutide administered as a single dose using two different SC presentations in participants living with overweight or obesity.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Maridebart cafraglutideAmgenOverweight and ObesityNCT07313761