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

Amgen

Status and phase: Enrolling; Phase 3

Conditions: Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight

Treatments: Drug: Maridebart cafraglutide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06858878

20210184

Details and patient eligibility

About

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

Enrollment: 999 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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999 participants in 4 patient groups, including a placebo group

Maridebart Cafraglutide High Dose

Experimental group

Description:

Participants will receive maridebart cafraglutide high dose subcutaneously (SC) for 72 weeks.

Treatment:

Drug: Maridebart cafraglutide

Maridebart Cafraglutide Medium Dose

Experimental group

Description:

Participants will receive maridebart cafraglutide medium dose SC for 72 weeks.

Treatment:

Drug: Maridebart cafraglutide

Maridebart Cafraglutide Low Dose

Experimental group

Description:

Participants will receive maridebart cafraglutide low dose SC for 72 weeks.

Treatment:

Drug: Maridebart cafraglutide

Placebo

Placebo Comparator group

Description:

Participants will receive placebo SC for 72 weeks.

Treatment:

Drug: Placebo