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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 With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight (MARITIME-2)

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

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. 17, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1. Age >= 18 years.
2. Body mass index >= 27 kg/m^2.
3. History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
4. Diagnosis of T2DM.

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

Both

Obesity, Overweight

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: Baseline and Week 72]
3. Participant achieving >= 10% Reduction in Body Weight from Baseline at Week 72 [Time Frame: Baseline and Week 72]
4. Participant achieving >= 15% Reduction in Body Weight from Baseline at Week 72 [Time Frame: Baseline and Week 72]
5. Change from Baseline in Systolic Blood Pressure (SBP) at Week 72 [Time Frame: Baseline and Week 72]
6. Percent Change from Baseline in Fasting Triglycerides at Week 72 [Time Frame: Baseline and Week 72]
7. Change from Baseline in Fasting Plasma Glucose at Week 72 [Time Frame: Baseline and Week 72]
8. Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72 [Time Frame: Baseline and Week 72]
9. Participant achieving HbA1c < 7% at Week 72 [Time Frame: Week 72]
10. 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]
11. Change from Baseline in Body Weight at Week 72 [Time Frame: Baseline and Week 72]
12. Participant achieving >= 20% reduction in body weight from baseline at week 72 [Time Frame: Baseline and Week 72]
13. Change from Baseline in Body Mass Index (BMI) at Week 72 [Time Frame: Baseline and Week 72]
14. Participant Achieving HbA1c <= 6.5% at Week 72 [Time Frame: Week 72]
15. Participant Achieving HbA1c < 5.7% at Week 72 [Time Frame: Week 72]
16. Percent Change from Baseline in Fasting Insulin 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 Urine Albumin-to-creatinine Ratio (uACR) at Week 72 [Time Frame: Baseline and Week 72]
19. Percent Change from Baseline at Week 72 in Fasting Concentration of Total Cholesterol [Time Frame: Baseline and Week 72]
20. Percent Change from Baseline at Week 72 in Fasting Concentration of Non-high-density Lipoprotein Cholesterol (non-HDL-C) [Time Frame: Baseline and Week 72]
21. Percent Change from Baseline at Week 72 in Fasting Concentration of Low-density Lipoprotein Cholesterol (LDL-C) [Time Frame: Baseline and Week72]
22. Percent Change from Baseline at Week 72 in Fasting Concentration of Very-low-density Lipoprotein Cholesterol (VLDL-C) [Time Frame: Baseline and Week 72]
23. Percent Change from Baseline at Week 72 in Fasting Concentration of High-density Lipoprotein Cholesterol (HDL-C) [Time Frame: Baseline and Week 72]
24. Change from Baseline in Diastolic Blood Pressure (DBP) at Week 72 [Time Frame: Baseline and Week 72]
25. 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]
26. Number of Participants who Experienced Treatment-emergent Adverse Events [Time Frame: Up to Week 84]
27. Number of Participants who Experienced Serious Adverse Events [Time Frame: Up to Week 84]
28. 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.

United States/Argentina/Bulgaria/Canada/Czechia/Germany/Hungary/Italy/Poland/South Korea/United Kingdom