Evaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight

Conditions

• Obesity

Eligibility Criteria

Sex

ALL

Age

18 Years - 99 Years

Healthy Volunteers

Not accepted

Interventions

• Maridebart Cafraglutide — DRUG
  Maridebart cafraglutide will be administered SC.
• Placebo — DRUG
  Placebo will be administered SC.

Study Details

The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.

Key Dates

First listed

Mar 5, 2025

Start date

Mar 12, 2025

Status verified

Oct 2025

Primary completion

Jan 21, 2027

Completion

Apr 16, 2027

Study Design

Enrollment

3,853 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Maridebart Cafraglutide High Dose
  Participants will receive maridebart cafraglutide high dose subcutaneously (SC) for 72 weeks.
• Experimental: Maridebart Cafraglutide Medium Dose
  Participants will receive maridebart cafraglutide medium dose SC for 72 weeks.
• Experimental: Maridebart Cafraglutide Low Dose
  Participants will receive maridebart cafraglutide low dose SC for 72 weeks.
• Placebo Comparator: Placebo
  Participants will receive placebo SC for 72 weeks.

Primary Outcome Measure

Percent Change From Baseline in Body Weight at Week 72 [ Time Frame: Baseline and Week 72 ]

Locations (74)

Find similar trials in Anniston, AL

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