Obesity, Overweight, Type 2 Diabetes Mellitus
Conditions
Interventions
- Experimental: Cohort A: Maridebart Cafraglutide
Part 1: Cohort A will consist of participants without a diagnosis of type 1 or type 2 diabetes mellitus. Participants will be randomized to receive
Sponsors
Hama Yoriko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >=18 years at the time of signing informed consent. 2. BMI >=30 kg/m^2, or >=27 kg/m^2 and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease for cohort A only. 3. For participants in cohort B only, HbA1c >= 7% and = 180 days prior to screening and either treated with diet and exercise alone or on stable (at least 90 days prior to screening) treatment with metformin, a sulfonylurea, or a sodium-glucose cotransporter 2 (SGLT2) inhibitor as monotherapy or combination therapy, per approved local label. 4. History of at least one unsuccessful dietary effort to lose body weight.
Exclusion criteria
Exclusion criteria: 1. Change in body weight greater than 5 kg within 3 months prior to screening. 2. Obesity induced by other endocrinologic disorders. 3. History of pancreatitis. 4. Family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN-2). 5. History of major depressive disorder within the last 2 years. 6. Any lifetime history of other major psychiatric disorder or suicide attempt.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Percent Change From Baseline to Week 52 in Body Weight [Time Frame: Baseline and Week 52] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of Participants Achieving >= 5% Reduction in Body Weight From Baseline at Week 52 [Time Frame: Baseline and Week 52] 2. Percentage of Participants Achieving >= 10% Reduction in Body Weight From Baseline at Week 52 [Time Frame: Baseline and Week 52] 3. Achievement of >= 15% Reduction in Body Weight From Baseline at Week 52 [Time Frame: Baseline and Week 52] 4. Achievement of >= 20% Reduction in Body Weight From Baseline at Week 52 [Time Frame: Baseline and Week 52] 5. Change from Baseline to Week 52 in Hemoglobin A1c (HbA1c) [Time Frame: Baseline and Week 52] 6. Change from Baseline to Week 52 in Fasting Serum Insulin [Time Frame: Baseline and Week 52] 7. Change from Baseline to Week 52 in Fasting Plasma Glucose [Time Frame: Baseline and Week 52] 8. Change from Baseline to Week 52 in Homeostasis Model Assessment for Insulin Resistance (HOMA2-IR) [Time Frame: Baseline and Week 52] 9. Change from Baseline to Week 52 in Homeostasis Model Assessment for Steady State Beta Cell Function (HOMA2-%B) [Time Frame: Baseline and Week 52] 10. Maximum Observed Plasma Concentration (Cmax) of maridebart cafraglutide [Time Frame: Up to Week 64] 11. Area Under the Concentration-time Curve (AUC) of maridebart cafraglutide [Time Frame: Up to Week 64] 12. Change from Baseline to Week 52 in Waist Circumference [Time Frame: Baseline and Week 52] 13. Change from Baseline to Week 52 in Body Weight [Time Frame: Baseline and Week 52] 14. Change from Baseline to Week 52 in Systolic Blood Pressure (SBP) [Time Frame: Baseline and Week 52] 15. Change from Baseline to Week 52 in Diastolic Blood Pressure (DBP) [Time Frame: Baseline and Week 52] 16. Change from Baseline to Week 52 in Body Fat Mass Using Dual-energy X-ray Absorptiometry (DEXA) [Time Frame: Baseline and Week 52] - Analyzed in a subset of participants. 17. Change from Baseline to Week 52 in Lean Body Mass Using DEXA [Time Frame: Baseline and Week 52] - Analyzed in a subset of participants. 18. Percent Change From Baseli | — |
Countries
Australia, Canada, Czechia, Germany, Hong Kong, Hungary, Japan, Poland, South Korea, Spain, Taiwan, United States
Contacts
Public ContactContact Local
Amgen K.K.
Outcome results
None listed