A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight (MARITIME-2)

Conditions

Chronic Weight Management

Brief summary

Percent change from baseline in body weight at week 72

Detailed description

Change from baseline in waist circumference (cm) at week 72, Achieving ≥ 5% reduction in body weight from baseline at week 72, Achieving ≥ 10% reduction in body weight from baseline at week 72, Achieving ≥ 15% reduction in body weight from baseline at week 72, Change from baseline in SBP (mmHg) at week 72, Percent change from baseline in fasting triglycerides at week 72, Change from baseline in fasting plasma glucose (mg/dL) at week 72, Change from baseline in hemoglobin A1c (HbA1c) (%, mmol/mol) at week 72, Achieving HbA1c < 7% at week 72, Change from baseline in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score at week 72

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGPlacebo for AMG 133 (maridebart cafraglutide)

DRUGAMG 133

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percent change from baseline in body weight at week 72	—

Secondary

Measure	Time frame
Change from baseline in waist circumference (cm) at week 72, Achieving ≥ 5% reduction in body weight from baseline at week 72, Achieving ≥ 10% reduction in body weight from baseline at week 72, Achieving ≥ 15% reduction in body weight from baseline at week 72, Change from baseline in SBP (mmHg) at week 72, Percent change from baseline in fasting triglycerides at week 72, Change from baseline in fasting plasma glucose (mg/dL) at week 72, Change from baseline in hemoglobin A1c (HbA1c) (%, mmol/mol) at week 72, Achieving HbA1c < 7% at week 72, Change from baseline in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score at week 72	—

Measure

Time frame

Change from baseline in waist circumference (cm) at week 72, Achieving ≥ 5% reduction in body weight from baseline at week 72, Achieving ≥ 10% reduction in body weight from baseline at week 72, Achieving ≥ 15% reduction in body weight from baseline at week 72, Change from baseline in SBP (mmHg) at week 72, Percent change from baseline in fasting triglycerides at week 72, Change from baseline in fasting plasma glucose (mg/dL) at week 72, Change from baseline in hemoglobin A1c (HbA1c) (%, mmol/mol) at week 72, Achieving HbA1c < 7% at week 72, Change from baseline in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score at week 72

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Countries

Bulgaria, Czechia, Germany, Hungary, Italy, Poland

Outcome results

None listed