A Phase 3, Randomized, Double-Blind Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Participants With Obesity or Overweight With Type 2 Diabetes Mellitus

Amgen

Summary

The primary objective of this trial is to evaluate the long-term efficacy, safety, and tolerability of maridebart cafraglutide in participants with obesity and type 2 diabetes mellitus. Trial 20210182 is extension of trial 20210184 (NCT06858878).

Eligibility

Age range: 18–99 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Signed informed consent form (ICF) indicating compliance with the requirements and restrictions listed in the ICF and this protocol. * Participants completing Study 20210184 must meet the following criteria: * Completed the Week 72 visit in Study 20210184. * Did not permanently discontinue the investigational product in the parent trial (20210184). * Randomized within 7 days of week 72 visit in the parent trial. * Participants must use protocol-specified contraception during treatment and for 16 weeks after the last dose of trial intervention. Exclusion Criteria:…

Locations (24)

Gilbert Center for Family Medicine
Gilbert, Arizona
San Fernando Valley Health Institute
Canoga Park, California
Core Healthcare Group
Cerritos, California
Velocity Clinical Research Chula Vista
Chula Vista, California
Empire Clinical Research
Pomona, California
Optimus U Corporation
Miami, Florida

Summary

Eligibility

Interventions

Locations (24)