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

Purpose

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

Condition

  • Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 and exercise. - Diagnosis of T2DM.

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-proliferative diabetic 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 days before screening. - History of unstable major depressive disorder (MDD) or other severe psychiatric disorder within 2 years before screening. - Lifetime history of suicide attempt.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Maridebart Cafraglutide High Dose 		Participants will receive maridebart cafraglutide high dose subcutaneously (SC) for 72 weeks.
  • Drug: Maridebart cafraglutide
    Maridebart cafraglutide will be adminstered SC.
    Other names:
    • AMG 133
    • MariTide
Experimental
Maridebart Cafraglutide Medium Dose 		Participants will receive maridebart cafraglutide medium dose SC for 72 weeks.
  • Drug: Maridebart cafraglutide
    Maridebart cafraglutide will be adminstered SC.
    Other names:
    • AMG 133
    • MariTide
Experimental
Maridebart Cafraglutide Low Dose 		Participants will receive maridebart cafraglutide low dose SC for 72 weeks.
  • Drug: Maridebart cafraglutide
    Maridebart cafraglutide will be adminstered SC.
    Other names:
    • AMG 133
    • MariTide
Placebo Comparator
Placebo 		Participants will receive placebo SC for 72 weeks.
  • Drug: Placebo
    Placebo will be adminstered SC.

Recruiting Locations

Brigham and Womens Hospital
Boston, Massachusetts 02115

More Details

Status
Recruiting
Sponsor
Amgen

Study Contact

Amgen Call Center
866-572-6436
medinfo@amgen.com