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

Condition studied

Chronic Weight Management

Investigational medicinal product(s)

Eligibility

Primary endpoint

Percent change from baseline of the parent trial in body weight, Incidence of treatment-emergent adverse events and serious adverse events

Endpoint detail

- Achieving ≥ 5% reduction from baseline of the parent trial in body weight - Achieving ≥ 10% reduction from baseline of the parent trial in body weight - Achieving ≥ 15% reduction from baseline of the parent trial in body weight - Achieving ≥ 20% reduction from baseline of the parent trial in body weight, Change from baseline of the parent trial in waist circumference, Change from baseline of the parent trial in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score, Percent change from baseline in body weight, - No gain of body weight from baseline of > 3% - No gain of body weight from baseline of > 5%, - Percent maintenance of body weight reduction achieved in the parent trial - Maintaining ≥ 80% of the body weight reduction achieved in the parent trial