A Phase 1, Randomized, Double-blind, Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Maridebart Cafraglutide After Switching From Glucagon-like Peptide-1 Receptor Agonists in Participants Living With Overweight or Obesity

Amgen

Summary

The primary purpose of the study is to assess the pharmacokinetics of maridebart cafraglutode after switching from weekly GLP-1RA in participants living with overweight or obesity.

Eligibility

Age range: 18–70 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * 18 to 70 years of age. * Body Mass Index (BMI) ≥ 25 at screening. * BMI ≥ 23 for Asian participants at screening. * Stable body weight (approximately 5% or less gain or loss) during the 4-week run-in period, unless the study doctor determines otherwise. * Stable dose of weekly GLP-1RA. * Stable gastrointestinal (GI) tolerability. * Contraception for females. * Stable for 3 months if obstructive sleep apnea (OSA), hypertension, hyperlipidemia, and/or hypothyroidism. * Willingness to follow trial procedures for the duration of the trial. Exclusion Criteria: * Type 1/Type…

Interventions

Locations (9)

Arizona Research Center
Phoenix, Arizona
Catalina Research Institute LLC (CRI) - Montclair
Montclair, California
Fortrea Clinical Research Unit - Daytona Beach
Daytona Beach, Florida
AGA Clinical Trials
Hialeah, Florida
K2 Medical Research Orlando
Maitland, Florida
The Alliance for Multispecialty Research - Lexington
Lexington, Kentucky