A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Obesity or Overweight, Without Type 2 Diabetes
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Obesity or Overweight, Without Type 2 Diabetes
The purpose of this study is to evaluate the efficacy and safety of eloralintide in adults with obesity or overweight who do not have type 2 diabetes. The study has two phases: a main phase and an extension phase.
Participation in the main phase of the study will last about 75 weeks. Participants with prediabetes will continue in the extension phase for another 2 years.
Inclusion Criteria:
Have Body Mass Index (BMI) at screening of the following:
30 kilogram per square meter (kg/m2) OR
27 kg/m2 with at least one of the following weight-related health conditions at screening:
Have a stable body weight (<5% body weight change) for 90 days prior to screening.
Have a history of at least one self-reported unsuccessful dietary effort to reduce body weight
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 or type 2 diabetes
Have had within 90 days prior to screening:
Have a history or diagnosis of New York Heart Association Functional Classification Class IV congestive heart failure
Have taken medications or alternative remedies intended for weight loss within 90 days of screening
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