Effect of Retatrutide Compared With Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2)
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT06260722
- Lead Sponsor
- Eli Lilly and Company
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1250
- 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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Retatrutide Dose Level 2 Retatrutide Participants will receive retatrutide administered SC. Semaglutide Semaglutide Participants will receive semaglutide administered SC. Retatrutide Dose Level 1 Retatrutide Participants will receive retatrutide administered subcutaneously (SC).
- Primary Outcome Measures
Name Time Method Change from Baseline in Hemoglobin A1c (HbA1c) (%) Baseline, Week 80
- Secondary Outcome Measures
Name Time Method Change from Baseline in HbA1c (%) Baseline, Week 80 Percentage of Participants Who Achieve HbA1c ≤ 6.5% Week 80 Percentage of Participants Who Achieve HbA1c < 5.7% Week 80 Percent Change from Baseline in Body Weight Week 80 Change from Baseline in Body Weight Baseline, Week 80 Percentage of Participants Who Achieve Weight Reduction of ≥ 5% Week 80 Percentage of Participants Who Achieve Weight Reduction of ≥ 10% Week 80 Percentage of Participants Who Achieve Weight Reduction of ≥ 15% Week 80 Percentage of Participants Who Achieve HbA1c ≤ 6.5% and ≥ 10% Weight Reduction Week 80 Percent Change from Baseline in Triglycerides Week 80 Percent Change from Baseline in Non- high-density lipoprotein (HDL) Cholesterol Week 80 Change from Baseline in Systolic Blood Pressure (SBP) Baseline, Week 80
Trial Locations
- Locations (77)
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
Scroll for more (67 remaining)University of Alabama - Department of Nutrition Sciences🇺🇸Birmingham, Alabama, United States