Endocrinology: Clinical Research Program

Endocrinology: Clinical Studies Open For Enrollment

Male or female, 18 Years and older
Have a BMI ≥35 kg/m2 at screening (Visit 1)
No T2D diagnosis with an HbA1c <6.5% (<48 mmol/mol), as determined by the central laboratory at screening (Visit 1), OR T2D diagnosis with an HbA1c ≥6.5% to ≤9.5% (≥48 mmol/mol to ≤80 mmol/mol), as determined by the central laboratory at screening (Visit 1)
Have a history of at least 1 self-reported unsuccessful dietary effort to reduce body weight
IOCBP must not be pregnant, intending to be pregnant, breastfeeding, or intending to breastfeed
Exclusion Criteria
- Have a self-reported change in body weight >5 kg (11 pounds) within 90 days before screening (Visit 1)
- Have a prior or planned surgical treatment for obesity
- Have a prior or planned endoscopic procedure and/or device-based therapy for obesity.
- Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening
- Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- Have had within the past 90 days before screening:
  - acute myocardial infarction
  - cerebrovascular accident (stroke)
  - coronary revascularization
  - hospitalization for unstable angina, or
  - hospitalization due to congestive heart failure
- Have New York Heart Association Functional Classification Class IV congestive heart failure
- Have a history of chronic or acute pancreatitis

Enrollment Status: Enrolling

Michael Goldberg, MD