Phase 3Recruiting
Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-2-EXTENSION)
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
- Sponsor
- Amgen (Industry)
- Enrolment
- 950 planned
- Conditions
- Obesity; Overweight; Diabetes Mellitus, Type 2
- Interventions
- Maridebart Cafraglutide; Placebo
- Ages
- adults, older adults
- Registry
- NCT07684144
From the registry
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).
Primary outcomes
- Percent Change in Body Weight from Baseline of the Parent Trial (20210184)
- Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)