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A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight

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

Hama Yoriko

Amgen K.K.

Midtown Tower 9-7-1 Akasaka, Minato-ku, Tokyo

clinicaltrials_japan@amgen.com

Local Contact

Amgen K.K.

Midtown Tower 9-7-1 Akasaka, Minato-ku, Tokyo

+81-80-7217-8592

clinicaltrials_japan@amgen.com

Not Recruiting

Mar. 12, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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.

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.

Both

Obesity

Experimental: Maridebart Cafraglutide High Dose
Participants will receive maridebart cafraglutide high dose subcutaneously (SC) for 72 weeks.
Interventions: Drug: Maridebart Cafraglutide

Experimental: Maridebart Cafraglutide Medium Dose
Participants will receive maridebart cafraglutide medium dose SC for 72 weeks.
Interventions: Drug: Maridebart Cafraglutide

Experimental: Maridebart Cafraglutide Low Dose
Participants will receive maridebart cafraglutide low dose SC for 72 weeks.
Interventions: Drug: Maridebart Cafraglutide

Placebo Comparator: Placebo
Participants will receive placebo SC for 72 weeks.
Interventions: Drug: Placebo

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

1. Change From Baseline in Waist Circumference at Week 72 [Time Frame: Baseline and Week 72]
2. Participant achieving >= 5% Reduction in Body Weight from Baseline at Week 72 [Time Frame: Week 72]
3. Participant achieving >= 10% Reduction in Body Weight from Baseline at Week 72 [Time Frame: Week 72]
4. Participant achieving >= 15% Reduction in Body Weight from Baseline at Week 72 [Time Frame: Week 72]
5. Participant achieving >= 20% Reduction in Body Weight from Baseline at Week 72 [Time Frame: Week 72]
6. Change From Baseline in Systolic Blood Pressure (SBP) at Week 72 [Time Frame: Baseline and Week 72]
7. Percent Change From Baseline in Fasting Triglycerides at Week 72 [Time Frame: Baseline and Week 72]
8. Change From Baseline in Fasting Glucose at Week 72 [Time Frame: Baseline and Week 72]
9. 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 [Time Frame: 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.
10. Change From Baseline in Body Weight at Week 72 [Time Frame: Baseline and Week 72]
11. Change From Baseline in Body Mass Index (BMI) at Week 72 [Time Frame: Baseline and Week 72]
12. Change From Baseline in Hemoglobin A1c at Week 72 [Time Frame: Baseline and Week 72]
13. Percent Change From Baseline in Fasting Insulin at Week 72 [Time Frame: Baseline and Week 72]
14. Change From Baseline in Glycemic Status at Week 72 [Time Frame: Baseline and Week 72]
15. Percent Change From Baseline in Fasting Lipid Parameters at Week 72 [Time Frame: 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).
16. Change From Baseline in Diastolic Blood Pressure (DBP) at Week 72 [Time Frame: Baseline and Week 72]
17. Percent Change From Baseline in High-sensitivity C-reactive Protein (hs-CRP) at Week 72 [Time Frame: Baseline and Week 72]
18. Change From Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Physical Function Domain Score at Week 72 [Time Frame: 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.
19. Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [Time Frame: Up to approximately 88 weeks]
20. Plasma Concentration of Maridebart Cafraglutide at Week 72 [Time Frame: Week 72]

Mar. 14, 2025

Yes

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

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