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

Conditions

Chronic Weight Management

Brief summary

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

Detailed description

- 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 hemoglobin A1c (HbA1c), 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, Change from baseline in HbA1c, Change from baseline of the parent trial in waist circumference

Related papers

No related papers found yet.

Interventions

DRUGAMG 133

DRUGPlacebo for AMG 133 (maridebart cafraglutide)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

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

Secondary

Measure	Time frame
- 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 hemoglobin A1c (HbA1c), 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, Change from baseline in HbA1c, Change from baseline of the parent trial in waist circumference	—

Measure

Time frame

- 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 hemoglobin A1c (HbA1c), 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, Change from baseline in HbA1c, Change from baseline of the parent trial in waist circumference

—

Outcome results

None listed