Overview
The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with placebo in participants with persistent obesity or overweight, with or without type 2 diabetes, and on stable incretin background therapy.
Participation in the study will last about 80 weeks.
Eligibility
Inclusion Criteria:
- Are on stable incretin therapy at screening
- With persistent obesity or overweight defined as:
- ≥30 kg/m2 OR
- ≥27 kg/m2 with at least one existing obesity related complication at screening:
- hypertension
- dyslipidemia
- obstructive sleep apnea
- cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure), or
- type 2 diabetes
- Have a stable body weight (\<5% body weight change) at screening
Exclusion Criteria:
- Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed \>1 year before screening)
- Have a prior or planned endoscopic procedure and/or device-based therapy for obesity (prior device-based therapy acceptable if device removal was more than 6 months prior to screening)
- Have type 1 diabetes
- Have taken any of the following antihyperglycemic medications within 90 days before screening:
- dipeptidyl peptidase-4 (DPP-4) inhibitors
- amylin analogs
- insulin
- Have had within 90 days prior to screening:
- heart attack
- stroke
- coronary artery revascularization
- unstable angina, or
- hospitalization due to congestive heart failure
- Have a history or diagnosis of New York Heart Association Functional Classification Class IV congestive heart failure