Effect of Retatrutide Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1)
- Registration Number
- NCT06354660
- Lead Sponsor
- Eli Lilly and Company
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 480
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Retatrutide Dose Level 2 Retatrutide Participants will receive retatrutide administered SC. Retatrutide Dose Level 3 Retatrutide Participants will receive retatrutide administered SC. Placebo Placebo Participants will receive placebo 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 40
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Achieve Weight Reduction of ≥ 5% Week 40 Change from Baseline in Body Weight Baseline, Week 40 Percentage of Participants Who Achieve Weight Reduction of ≥ 10% Week 40 Percent Change from Baseline in Body Weight Baseline, Week 40 Percentage of Participants Who Achieve HbA1c < 7.0% Week 40 Percentage of Participants Who Achieve HbA1c ≤ 6.5% Week 40 Percentage of Participants Who Achieve HbA1c < 5.7% Week 40 Change from Baseline in Fasting Serum Glucose Baseline, Week 40 Percentage of Participants Who Achieve Weight Reduction of ≥ 15% Week 40 Percentage of Participants Who Achieve HbA1c ≤ 6.5% and ≥ 10% Weight Reduction Week 40 Percent Change from Baseline in Triglycerides Baseline, Week 40 Percent Change from Baseline in Non- High-Density Lipoprotein (HDL) Cholesterol Baseline, Week 40 Change from Baseline in Systolic Blood Pressure (SBP) Baseline, Week 40
Trial Locations
- Locations (47)
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
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