Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight

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

Phase

3

Condition

Diabetes Prevention

Diabetes Mellitus, Type 2

Obesity

Treatment

Maridebart cafraglutide

Placebo

Clinical Study ID

NCT06858878
20210184
  • 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 ≥ 27 kg/m^2.

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

  • Diagnosis of T2DM.

Exclusion

Exclusion Criteria:

  • Type 1 diabetes mellitus.

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

  • Proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferativediabetic retinopathy that requires acute treatment.

  • Obesity induced by other endocrinologic disorders.

  • 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: 999
Treatment Group(s): 2
Primary Treatment: Maridebart cafraglutide
Phase: 3
Study Start date:
March 17, 2025
Estimated Completion Date:
April 16, 2027

Connect with a study center

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    Niagara Falls, Ontario L2H 1H5
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  • Nakamoto Medical Clinic

    Mito-shi, Ibaraki 310-0826
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  • Nakakinen Clinic

    Naka-shi, Ibaraki 311-0113
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  • Ohishi Naika Clinic

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