Study Complete
Sponsor ID
20240195

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

Sponsor ID
20240195
Clinicaltrials.gov ID
NCT06976372
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

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.

Additional Study Details

Phase
Phase 1
Product
AMG 133
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
120
Additional Study Details

Protocol Summary

Primary Outcome Measures

Maximum Concentration (Cmax) of AMG 133

Timeframe: Up to Day 99

Area Under the Plasma Concentration‑time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of AMG 133

Timeframe: Day 29

Area Under the Plasma Concentration‑time Curve from Time Zero to Infinity (AUCinf) of AMG 133

Timeframe: Day 29

Area Under the Plasma Concentration‑time Curve Over the Dosing Interval (AUCtau) of AMG 133

Timeframe: Day 1 and Day 15

Secondary Outcome Measures

Number of Participants Who Experience Treatment-emergent Adverse Events

Timeframe: Up to Day 99

Number of Participants Who Experience Serious Adverse Events

Timeframe: Up to Day 99

Number of Participants Who Develop Anti-AMG 133 Antibodies

Timeframe: Up to Day 99

Locations

Location
Status
Contact Us
Location
Fortrea Clinical Research Unit - Dallas
Dallas, Texas, United States, 75247
Status
Recruiting
Location
CenExel Collaborative Neuroscience Research, LLC Los Alamitos
Los Alamitos, CA, United States, 90720
Status
Recruiting
Location
CenExel
Anaheim, CA, United States, 92801
Status
Recruiting