DRUG
Retatrutide
Administered SC.
Status
Completed
Phase
Phase 3
Enrollment
537
Locations
48
Results
Not posted
Publications
1
Study summary
The purpose of this study is to investigate the efficacy and safety of retatrutide compared with placebo in participants with Type 2 Diabetes and inadequate glycemic control. The study will last about 11 months and may include up to 11 visits.
Interventions
DRUG
Administered SC.
DRUG
Administered SC.
Timeline
First posted
Apr 9, 2024
Study start
Apr 10, 2024
Primary completion
Jan 22, 2026
Study completion
Feb 20, 2026
Results posted
Not reported
Registry updated
Mar 5, 2026
Outcomes
Change from Baseline in Hemoglobin A1c (HbA1c) (%)
Time frame · Baseline, Week 40
Percentage of Participants Who Achieve HbA1c < 7.0%
Time frame · Week 40
Percentage of Participants Who Achieve HbA1c ≤ 6.5%
Time frame · Week 40
Percentage of Participants Who Achieve HbA1c < 5.7%
Time frame · Week 40
Change from Baseline in Fasting Serum Glucose
Time frame · Baseline, Week 40
Percent Change from Baseline in Body Weight
Time frame · Baseline, Week 40
Change from Baseline in Body Weight
Time frame · Baseline, Week 40
Percentage of Participants Who Achieve Weight Reduction of ≥ 5%
Time frame · Week 40
Percentage of Participants Who Achieve Weight Reduction of ≥ 10%
Time frame · Week 40
Percentage of Participants Who Achieve Weight Reduction of ≥ 15%
Time frame · Week 40
Percentage of Participants Who Achieve HbA1c ≤ 6.5% and ≥ 10% Weight Reduction
Time frame · Week 40
Eligibility
Inclusion Criteria: * Have Type 2 Diabetes (T2D) * Have HbA1c ≥ 7.0% to ≤ 9.5% * Are naïve to insulin therapy and have not used oral or injectable antihyperglycemic (diabetes) medication for at least 90 days prior to screening * Are of stable weight for at least 90 days prior to screening * Have a Body Mass Index (BMI) ≥ 23.0 kilograms per meter squared (kg/m\^2) Exclusion Criteria: * Have Type 1 Diabetes (T1D) * Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening * Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening * Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema * Have an estimated glomerular filtration rate (eGFR) \<15 milliliters/minute/1.73 meter squared (mL/min/1.73 m\^2) as determined by the central laboratory * Have a prior or planned surgical treatment for obesity * Have New York Heart Association Functional Classification IV congestive heart failure * Have had an acute myocardial infarction, stroke, or were hospitalized for congestive heart failure within 90 days prior to screening * Have a known clinically significant gastric emptying abnormality * Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years * Have any lifetime history of a suicide attempt * Had chronic or acute pancreatitis * Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2 * Have taken prescribed or over-the-counter medication, or alternative remedies, intended to promote body weight reduction within 90 days prior to screening.
Study locations
India · Mexico · Puerto Rico · United States. Showing up to 24 locations stored in the fast local snapshot.
Scottsdale Clinical Trials
Scottsdale, Arizona, United States
Tucson Clinical Research Institute
Tucson, Arizona, United States
San Fernando Valley Health Institute
Canoga Park, California, United States
Ark Clinical Research
Long Beach, California, United States
Northeast Research Institute (NERI)
Fleming Island, Florida, United States
New Horizon Research Center
Miami, Florida, United States
Ezy Medical Research
Miami, Florida, United States
Clinical Research of Central Florida
Winter Haven, Florida, United States
Trinity Research Centers
Marietta, Georgia, United States
Cotton O'Neil Clinical Research Center
Topeka, Kansas, United States
NECCR PrimaCare Research
Fall River, Massachusetts, United States
Clinical Research Professionals
Chesterfield, Missouri, United States
Boeson Research MSO
Missoula, Montana, United States
NJ MedCare & NJ Heart
Linden, New Jersey, United States
Accellacare - Wilmington - 1917 Tradd Court
Wilmington, North Carolina, United States
Providence Health Partners-Center for Clinical Research
Dayton, Ohio, United States
Clinical Research of Philadelphia
Philadelphia, Pennsylvania, United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, United States
Delricht Research - Tobias Gadson Boulevard - Charleston
Charleston, South Carolina, United States
Lifedoc Research - Lenox Park Drive
Memphis, Tennessee, United States
Clinical Research Associates Inc
Nashville, Tennessee, United States
Velocity Clinical Research, Dallas
Dallas, Texas, United States
Prime Revival Research Institute, LLC
Flower Mound, Texas, United States
Valley Institute of Research - Fort Worth
Fort Worth, Texas, United States
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