Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AMG 133 in Adult Participants With Overweight or Obesity, With or Without Type 2 Diabetes Mellitus
- Conditions
- Obesity, Overweight, Type 2 Diabetes Mellitus
- Registration Number
- JPRN-jRCT2031220664
- Lead Sponsor
- Hama Yoriko
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 570
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 <= 10% (53 to 86 mmol/mol) at screening with an established diagnosis of type 2 diabetes mellitus for >= 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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method