Study Complete
Sponsor ID
20230259

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

Sponsor ID
20230259
Clinicaltrials.gov ID
NCT07226778
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

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.

Additional Study Details

Phase
Phase 1
Product
AMG 133
Type
Interventional
Masking
None (Open Label)
Enrollment
348
Additional Study Details

Protocol Summary

Primary Outcome Measures

Area Under the Plasma Concentration Time Curve from Time Zero to Infinity (AUCinf) of Maridebart Cafraglutide

Timeframe: Up to Day 120

Area Under the Plasma Concentration Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of Maridebart Cafraglutide

Timeframe: Up to Day 120

Maximum Observed Plasma Concentration (Cmax) of Maridebart Cafraglutide

Timeframe: Up to Day 120

Secondary Outcome Measures

Number of Participants with Treatment-emergent Adverse Events

Timeframe: Up to Day 120

Number of Participants with Serious Adverse Events

Timeframe: Up to Day 120

Number of Participants with Anti-maridebart Cafraglutide Antibody Formation

Timeframe: Up to Day 120

Locations

Location
Status
Contact Us
Location
Fortrea Clinical Research Unit - Daytona Beach
Daytona Beach, FL, United States, 32117-5116
Status
Recruiting
Location
Fortrea Clinical Research Unit - Dallas
Dallas, Texas, United States, 75247-4989
Status
Recruiting
Location
Fortrea Clinical Research Unit Inc. - Madison
Madison, WI, United States, 53704-2526
Status
Recruiting
Location
Anaheim Clinical Trials
Anaheim, California, United States, 92801-2658
Status
Recruiting