RecruitingPhase 3NCT07357415
A Study of Retatrutide (LY3437943) in Participants Without Type 2 Diabetes Who Have Obesity or Overweight
A Phase 3b Study to Investigate the Efficacy and Safety of Different Retatrutide Dose Escalation Schemes in Participants Without Type 2 Diabetes Who Have Obesity or Overweight: A Randomized, Controlled, Double-Blind Trial
Sponsor
Eli Lilly and Company
Enrollment
600 participants
Start Date
Jan 24, 2026
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to investigate the efficacy and safety of different retatrutide dose escalation schemes in participants without type 2 diabetes who have obesity or overweight. Participation in the study will last about 113 weeks.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- Have a Body Mass Index (BMI) at screening
- ≥ 30 kilogram per square meter (kg/m2) OR
- ≥ 27 kg/m2 with presence of at least one of the following weight-related conditions at screening: high blood pressure, abnormal levels of lipid, obstructive sleep apnea, heart disease
- Have at least one unsuccessful attempt to lose weight by dieting
Exclusion Criteria11
- Have a self-reported change in body weight \>5 kilograms (kg) (11 pounds) within 90 days before screening
- Have a prior or planned surgical treatment for obesity
- Have type 1 diabetes or type 2 diabetes
- 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:
- heart attack
- stroke
- hospitalization for unstable angina or heart failure
- Have New York Heart Association Functional Classification Class IV congestive heart failure
- Have a history of chronic or acute pancreatitis
- Have taken weight loss drugs, including over-the counter medications within 90 days prior to screening
Interventions
DRUGRetatrutide
Administered SC
Locations(35)
View Full Details on ClinicalTrials.gov
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NCT07357415
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