Study Complete
Sponsor ID
20210268

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

Sponsor ID
20210268
Clinicaltrials.gov ID
NCT07313761
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
349
Additional Study Details

Protocol Summary

Primary Outcome Measures

Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Infinity (AUCinf) of AMG 133

Timeframe: Up to Day 120

AUC From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of AMG 133

Timeframe: Up to Day 120

Maximum Observed Plasma Concentration (Cmax) of AMG 133

Timeframe: Up to Day 120

Secondary Outcome Measures

Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs)

Timeframe: Day 1 to Day 120

Number of Participants who Experienced Serious AEs (SAEs)

Timeframe: Screening to Day 120 (up to 148 days)

Number of Participants with Positive Anti-AMG 133 Antibodies

Timeframe: Up to Day 120

Locations

Location
Status
Contact Us
Location
Clinical Pharmacology Of Miami, LLC
Miami, FL, United States, 33172-3161
Status
Recruiting
Location
CenExel Collaborative Neuroscience Research, LLC Los Alamitos
Los Alamitos, CA, United States, 90720
Status
Recruiting
Location
Anaheim Clinical Trials
Anaheim, California, United States, 92801-2658
Status
Recruiting
Location
Ohio Clinical Trials, Inc.
Columbus, OH, United States, 43212
Status
Recruiting