Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight (MARITIME-2)
Recruiting
- Conditions
- Obesity, Overweight
- Registration Number
- jRCT2031250038
- Lead Sponsor
- Amgen K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 999
Inclusion Criteria
- Age >= 18 years.
- Body mass index >= 27 kg/m^2.
- History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
- Diagnosis of T2DM.
Exclusion Criteria
- Type 1 diabetes mellitus.
- Self-reported change in body weight > 5 kg within 90 days before screening.
- Proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment.
- Obesity induced by other endocrinologic disorders.
- 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.
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