RECRUITINGPhase 3INTERVENTIONAL
A Study of Retatrutide (LY3437943) in Participants With Obesity or Overweight
A Phase 3b Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly in Participants Without Type 2 Diabetes Who Have Obesity or Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Retatrutide
Administered SC
DRUG
Placebo
Administered SC
Locations (20)
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
IMA Clinical Research Warren
Warren Township, New Jersey, United States
IMA Clinical Research Manhattan
New York, New York, United States
Trial Management Associates - Wilmington - Floral Parkway
Wilmington, North Carolina, United States
Cedar Health Research
Dallas, Texas, United States
Headlands Research-El Paso
El Paso, Texas, United States
Cedar Health Research - Euless
Euless, Texas, United States
Cedar Health Research - Fort Worth
Fort Worth, Texas, United States
Care Access - Houston
Houston, Texas, United States
IMA Clinical Research San Antonio
San Antonio, Texas, United States
FutureMeds - Birmingham
Birmingham, United Kingdom