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

Recruiting

• Conditions: Obesity

• Registration Number: jRCT2031250028
• Lead Sponsor: Amgen K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-12
• Study First Submitted: 2025-04-22
• Last Update Posted: 2025-04-22

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 3501

Inclusion Criteria

1. Age >= 18 years.
2. 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).
3. History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.

Exclusion Criteria

1. Type 1 or Typ2 diabetes mellitus.
2. Obesity induced by other endocrinologic disorders.
3. Self-reported change in body weight > 5 kg within 90 days before screening.
4. Family (first-degree relative[s]) or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2.
5. History of chronic pancreatitis or History of acute pancreatitis within 180 days before screening.
6. History of unstable major depressive disorder (MDD) or other severe psychiatric disorder within 2 years before screening.
7. Lifetime history of suicide attempt.

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
-		1. Percent Change From Baseline in Body Weight at Week 72 [Time Frame: Baseline and Week 72]

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score at Week 72	Baseline and Week 72	The IWQOL-Lite-CT is a 20-item questionnaire designed to assess the impact of weight on quality of life in clinical trials. Items are scored on a 5-point Likert scale, with raw scores transformed to a 0-100 scale, where higher scores indicate better quality of life and less weight-related impact.
Percent Change From Baseline in Fasting Lipid Parameters at Week 72	Baseline and Week 72	Lipid parameters include: total cholesterol, non-high-density lipoprotein cholesterol (non-HDL-C), low-density lipoprotein cholesterol (LDL-C), very-low-density lipoprotein cholesterol (VLDL-C), and high-density lipoprotein cholesterol (HDL-C).
Change From Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Physical Function Domain Score at Week 72	Baseline and Week 72	The SF-36v2 Acute Physical Function domain score measures an individual's ability to perform daily physical activities, such as walking and climbing stairs, over the past week. It includes 8 items scored on a 3-point Likert scale, with raw scores transformed to a 0-100 scale. Higher scores indicate better physical functioning and fewer limitations due to physical health.