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

Not Applicable

Recruiting

• Conditions: Overweight; Obesity
• Interventions: Drug: Maridebart Cafraglutide

• Registration Number: NCT07226778
• Lead Sponsor: Amgen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-10-10
• Status Verified: 2025-11
• Study First Submitted: 2025-11-07
• Study First Submitted QC: 2025-11-07
• Last Update Submitted: 2025-11-07
• Study First Posted: 2025-11-10
• Last Update Posted: 2025-11-10
• Primary Completion: 2026-05-12
• Study Completion: 2026-05-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maridebart Cafraglutide SC Presentation 1	Maridebart Cafraglutide	Participants will receive a single dose of maridebart cafraglutide administered using SC presentation 1.
Maridebart Cafraglutide SC Presentation 2	Maridebart Cafraglutide	Participants will receive a single dose of maridebart cafraglutide administered using SC presentation 2.

Primary Outcome Measures

Name	Time	Method
Area Under the Plasma Concentration Time Curve from Time Zero to Infinity (AUCinf) of Maridebart Cafraglutide	Up to Day 120
Area Under the Plasma Concentration Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of Maridebart Cafraglutide	Up to Day 120
Maximum Observed Plasma Concentration (Cmax) of Maridebart Cafraglutide	Up to Day 120

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Treatment-emergent Adverse Events	Up to Day 120
Number of Participants with Serious Adverse Events	Up to Day 120
Number of Participants with Anti-maridebart Cafraglutide Antibody Formation	Up to Day 120

Trial Locations

Locations (4)

Anaheim Clinical Trials; 🇺🇸 Anaheim, California, United States

Fortrea Clinical Research Unit - Daytona Beach; 🇺🇸 Daytona Beach, Florida, United States

Fortrea Clinical Research Unit - Dallas; 🇺🇸 Dallas, Texas, United States

Fortrea Clinical Research Unit Inc. - Madison; 🇺🇸 Madison, Wisconsin, United States