DRUG
Retatrutide
Administered SC
Status
Active, not recruiting
Phase
Phase 3
Enrollment
320
Locations
76
Results
Not posted
Publications
0
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 renal impairment, with inadequate glycemic control on basal insulin alone or a combination of basal insulin with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study will last about 14 months and may include up to 22 visits.
Interventions
DRUG
Administered SC
DRUG
Administered SC
Timeline
First posted
Mar 7, 2024
Study start
Mar 15, 2024
Primary completion
Oct 2026
Study completion
Nov 2026
Results posted
Not reported
Registry updated
Jul 20, 2026
Outcomes
Change from Baseline in Hemoglobin A1c (HbA1c) (%)
Time frame · Baseline, Week 52
Percentage of Participants Achieving HbA1c <7.0%
Time frame · Week 52
Percentage of Participants Achieving HbA1c ≤6.5%
Time frame · Week 52
Change from Baseline in Fasting Serum Glucose
Time frame · Baseline, Week 52
Percentage of Time Continuous Glucose Monitoring (CGM) Glucose Values are Between 70 and 180 mg/dL
Time frame · Week 52
Measured during the CGM session that occurs during 30 days prior to Week 52
Percent Change from Baseline in Body Weight
Time frame · Baseline, Week 52
Change from Baseline in Body Weight
Time frame · Baseline, Week 52
Percentage of Participants Achieving Weight Reduction of ≥5%
Time frame · Week 52
Percentage of Participants Achieving Weight Reduction of ≥10%
Time frame · Week 52
Percentage of Participants Achieving Weight Reduction of ≥15%
Time frame · Week 52
Percentage of Participants Achieving HbA1c ≤6.5% and ≥10% Weight Reduction
Time frame · Week 52
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 moderate or severe renal impairment * Have been on the following stable diabetes treatment during 90 days prior to screening * basal insulin (≥20 International Units (IU)/day) with or without * metformin and/or SGLT2 inhibitor * 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/m2) 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 a history of unstable or rapidly progressing renal disease * Have a prior or planned surgical treatment for obesity * Have New York Heart Association Functional Classification III or IV congestive heart failure * Have had 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 a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2. * Have any lifetime history of a suicide attempt * Had chronic or acute pancreatitis * 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 · Brazil · Israel · Mexico · Puerto Rico · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
Nephrology Consultants
Huntsville, Alabama, United States
Clinical Research Institute of Arizona (CRI) - Sun City West
Sun City West, Arizona, United States
Kidney & Hypertension Center - Apple Valley
Apple Valley, California, United States
Hope Clinical Research, Inc.
Canoga Park, California, United States
Neighborhood Healthcare Institute of Health
Escondido, California, United States
EndoTrials Center for Clinical Research
La Mesa, California, United States
UCLA South Bay Endocrinology
Torrance, California, United States
Northeast Research Institute (NERI)
Fleming Island, Florida, United States
Encore Medical Research - Weston
Weston, Florida, United States
Orita Clinical Research
Decatur, Georgia, United States
CARE Institute
Idaho Falls, Idaho, United States
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, United States
Billings Clinic
Billings, Montana, United States
Excel Clinical Research, LLC
Las Vegas, Nevada, United States
Albany Medical College, Division of Community Endocrinology
Albany, New York, United States
NYC Research INC
Long Island City, New York, United States
Research Foundation of SUNY - University of Buffalo
Williamsville, New York, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, United States
Central States Research
Tulsa, Oklahoma, United States
Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
Pittsburgh, Pennsylvania, United States
AM Diabetes & Endocrinology Center
Bartlett, Tennessee, United States
Velocity Clinical Research, Dallas
Dallas, Texas, United States
Prime Revival Research Institute, LLC
Flower Mound, Texas, United States
Juno Research
Houston, Texas, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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