Evaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight (MARITIME-1)

Amgen

Status and phase: Enrolling; Phase 3

Conditions: Obesity

Treatments: Drug: Placebo; Drug: Maridebart Cafraglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT06858839

2024-515524-36 (EudraCT Number)

20210181

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: 3,501 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years.
• Body mass index ≥ 30 kg/m2 or ≥27 kg/m² to < 30 kg/m2 with at least 1 of the following weight-related comorbidities: hypertension, dyslipidemia, history of obstructive sleep apnea, history of cardiovascular disease, history of metabolic dysfunction-associated steatotic liver disease (MASLD) or Metabolic Dysfunction-Associated Steatohepatitis (MASH).
• History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.

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 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

---

3,501 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