DRUG
Retatrutide
Administered SC.
Status
Active, not recruiting
Phase
Phase 3
Enrollment
1,250
Locations
77
Results
Not posted
Publications
0
Study summary
The purpose of this study is to investigate the efficacy and safety of retatrutide compared with semaglutide in participants with Type 2 Diabetes and inadequate glycemic control with metformin with or without sodium-glucose cotransporter-2 inhibitor (SGLT2i). The study will last about 26 months and may include up to 24 visits.
Interventions
DRUG
Administered SC.
DRUG
Administered SC.
Timeline
First posted
Feb 15, 2024
Study start
Feb 21, 2024
Primary completion
Aug 2026
Study completion
Jan 2027
Results posted
Not reported
Registry updated
Apr 13, 2026
Outcomes
Change from Baseline in Hemoglobin A1c (HbA1c) (%)
Time frame · Baseline, Week 80
Change from Baseline in HbA1c (%)
Time frame · Baseline, Week 80
Percentage of Participants Who Achieve HbA1c ≤ 6.5%
Time frame · Week 80
Percentage of Participants Who Achieve HbA1c < 5.7%
Time frame · Week 80
Percent Change from Baseline in Body Weight
Time frame · Week 80
Change from Baseline in Body Weight
Time frame · Baseline, Week 80
Percentage of Participants Who Achieve Weight Reduction of ≥ 5%
Time frame · Week 80
Percentage of Participants Who Achieve Weight Reduction of ≥ 10%
Time frame · Week 80
Percentage of Participants Who Achieve Weight Reduction of ≥ 15%
Time frame · Week 80
Percentage of Participants Who Achieve HbA1c ≤ 6.5% and ≥ 10% Weight Reduction
Time frame · Week 80
Percent Change from Baseline in Triglycerides
Time frame · Week 80
Eligibility
Inclusion Criteria: * Have Type 2 Diabetes (T2D) * Have HbA1c ≥ 7.0% (53 millimoles per mole (mmol/mol)) to ≤ 10.5% (91 mmol/mol) * Have been on a stable diabetes treatment consisting of metformin ≥ 1500 milligrams per day (mg/day) with or without SGLT2i during 90 days prior to screening * Are of stable weight for at least 90 days prior to screening * Have a Body Mass Index (BMI) ≥ 25.0 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) \<45 milliliters/minute/1.73 meter squared (mL/min/1.73 m\^2) or lower than the country-specific threshold for discontinuing metformin therapy per local label 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
Argentina · Canada · Mexico · Puerto Rico · United States. Showing up to 24 locations stored in the fast local snapshot.
University of Alabama - Department of Nutrition Sciences
Birmingham, Alabama, United States
Neighborhood Healthcare Institute of Health
Escondido, California, United States
Long Beach Research Institute
Long Beach, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
Rancho Cucamonga Clinical Research
Rancho Cucamonga, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Arrow Clinical Trials
Daytona Beach, Florida, United States
New Age Medical Research Corporation
Miami, Florida, United States
South Broward Research
Miramar, Florida, United States
Clinical Research of Central Florida
Winter Haven, Florida, United States
Herman Clinical Research
Suwanee, Georgia, United States
North Georgia Clinical Research
Woodstock, Georgia, United States
Pacific Diabetes & Endocrine Center
Honolulu, Hawaii, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, United States
Deaconess Clinic - Gateway Health Center
Newburgh, Indiana, United States
IMA Clinical Research Monroe - Armand
Monroe, Louisiana, United States
MedStar Health Research Institute (MedStar Physician Based Research Network)
Hyattsville, Maryland, United States
Brigham and Women's Hospital Diabetes Program
Boston, Massachusetts, United States
NECCR PrimaCare Research
Fall River, Massachusetts, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, United States
Palm Research Center Tenaya
Las Vegas, Nevada, United States
Palm Research Center Sunset
Las Vegas, Nevada, United States
NYC Research INC
Long Island City, New York, United States
Medication Management
Greensboro, North Carolina, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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