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

Last updated: May 28, 2025
Sponsor: Amgen
Overall Status: Active - Recruiting

Phase

3

Condition

Obesity

Diabetes Mellitus, Type 2

Diabetes And Hypertension

Treatment

Maridebart Cafraglutide

Placebo

Clinical Study ID

NCT06858839
20210181
2024-515524-36
  • Ages 18-99
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years.

  • Body mass index ≥ 30 kg/m2 or ≥27 kg/m² to < 30 kg/m2 with at least 1 of thefollowing weight-related comorbidities: hypertension, dyslipidemia, history ofobstructive sleep apnea, history of cardiovascular disease, history of metabolicdysfunction-associated steatotic liver disease (MASLD) or MetabolicDysfunction-Associated Steatohepatitis (MASH).

  • History of at least 1 self-reported unsuccessful attempt at weight loss by diet andexercise.

Exclusion

Exclusion Criteria:

  • Type 1 or Typ2 diabetes mellitus.

  • Obesity induced by other endocrinologic disorders.

  • Self-reported change in body weight > 5 kg within 90 days before screening.

  • Family (first-degree relative[s]) or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2.

  • History of chronic pancreatitis or history of acute pancreatitis within 180 daysbefore screening.

  • History of unstable major depressive disorder (MDD) or other severe psychiatricdisorder within 2 years before screening.

  • Lifetime history of suicide attempt.

Study Design

Total Participants: 3501
Treatment Group(s): 2
Primary Treatment: Maridebart Cafraglutide
Phase: 3
Study Start date:
March 12, 2025
Estimated Completion Date:
April 16, 2027

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