A Study of Retatrutide (LY3437943) in Participants With Obesity or Overweight

Not Applicable

Not yet recruiting

• Conditions: Obesity; Overweight
• Interventions: Drug: Retatrutide; Drug: Placebo

• Registration Number: NCT07232719
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of retatrutide compared with placebo for body weight reduction.

Participation in the study will last about 65 weeks and may include about 18 visits.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-11
• Study First Submitted: 2025-11-14
• Study First Submitted QC: 2025-11-14
• Last Update Submitted: 2025-11-14
• Study First Posted: 2025-11-18
• Last Update Posted: 2025-11-18
• Study Start: 2025-12-01
• Primary Completion: 2027-07
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Have a body mass index (BMI) of:

  • ≥30 kilogram per square meter (kg/m2) OR
  • ≥27 kg/m2 with at least one of the following weight-related conditions: high blood pressure, abnormal levels of lipid, obstructive sleep apnea, heart disease

• Have at least one unsuccessful attempt to lose weight by dieting

Exclusion Criteria

• Have a self-reported change in body weight >5 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

  • acute myocardial infarction
  • cerebrovascular accident (stroke)
  • 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

• Have taken weight loss drugs, including over-the counter medications within 90 days prior to screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Retatrutide Dose 1	Retatrutide	Participants will receive retatrutide subcutaneously (SC)
Retatrutide Dose 2	Retatrutide	Participants will receive retatrutide SC
Placebo	Placebo	Participants will receive placebo SC

Primary Outcome Measures

Name	Time	Method
Percent Change from Baseline in Body Weight	Baseline, Week 56

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Systolic Blood Pressure	Baseline, Week 56
Change from Baseline in Waist Circumference	Baseline, Week 56
Percent Change from Baseline in Non-High-Density Lipoprotein (HDL) Cholesterol	Baseline, Week 56
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)	Baseline through Week 56

Trial Locations

Locations (32)

Artemis Institute for Clinical Research; 🇺🇸 Riverside, California, United States

JEM Research Institute; 🇺🇸 Atlantis, Florida, United States

Headlands Research Orlando; 🇺🇸 Orlando, Florida, United States

Care Access - Tamarac; 🇺🇸 Tamarac, Florida, United States

Care Access - Arlington Heights; 🇺🇸 Arlington Heights, Illinois, United States

L-MARC Research Center; 🇺🇸 Louisville, Kentucky, United States

IMA Clinical Research Monroe - Armand; 🇺🇸 Monroe, Louisiana, United States

Pharmasite Research, Inc.; 🇺🇸 Baltimore, Maryland, United States

Clinical Research Professionals; 🇺🇸 Chesterfield, Missouri, United States

Clinvest Headlands Llc; 🇺🇸 Springfield, Missouri, United States

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