A Study to Evaluate AMG 133 Administered Subcutaneously in Participants With Overweight or Obesity

Phase 1

Completed

• Conditions: Obesity; Overweight
• Interventions: Drug: AMG 133

• Registration Number: NCT06976372
• Lead Sponsor: Amgen

Brief Summary

The primary objective of this study is to assess the pharmacokinetics (PK) of AMG 133 after multiple subcutaneous (SC) administrations in participants with overweight or obesity using various dose regimens.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-20
• Primary Completion: 2024-12-27
• Study Completion: 2024-12-27
• Status Verified: 2025-04
• Study First Submitted: 2025-05-09
• Study First Submitted QC: 2025-05-09
• Last Update Submitted: 2025-05-09
• Study First Posted: 2025-05-16
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AMG 133 Dose A	AMG 133	Participants will receive AMG 133 Dose A SC, followed by subsequent doses of Dose C and Dose D.
AMG 133 Dose B	AMG 133	Participants will receive AMG 133 Dose B SC, followed by subsequent doses of Dose C and Dose D.
AMG 133 Dose C	AMG 133	Participants will receive AMG 133 Dose C SC, followed by subsequent doses of Dose C and Dose D.

Primary Outcome Measures

Name	Time	Method
Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCtau) of AMG 133	Day 1 and Day 15
Maximum Concentration (Cmax) of AMG 133	Up to Day 99
Area Under the Plasma Concentration-time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of AMG 133	Day 29
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of AMG 133	Day 29

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Experience Serious Adverse Events	Up to Day 99
Number of Participants Who Develop Anti-AMG 133 Antibodies	Up to Day 99
Number of Participants Who Experience Treatment-emergent Adverse Events	Up to Day 99

Trial Locations

Locations (3)

CenExel; 🇺🇸 Anaheim, California, United States

CenExel Collaborative Neuroscience Research, LLC Los Alamitos; 🇺🇸 Los Alamitos, California, United States

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