NCT06260722Active, not recruitingPhase 3
A Phase 3, Randomized, Multicenter, Open-label Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly Compared With Semaglutide Once Weekly in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2)
Eli Lilly and Company77 sites in 2 countries1,250 target enrollmentStarted: February 21, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Eli Lilly and Company
- Enrollment
- 1,250
- Locations
- 77
- Primary Endpoint
- Change from Baseline in Hemoglobin A1c (HbA1c) (%)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Retatrutide Dose Level 1
Experimental
Participants will receive retatrutide administered subcutaneously (SC).
Intervention: Retatrutide (Drug)
Retatrutide Dose Level 2
Experimental
Participants will receive retatrutide administered SC.
Intervention: Retatrutide (Drug)
Semaglutide
Active Comparator
Participants will receive semaglutide administered SC.
Intervention: Semaglutide (Drug)
Outcomes
Primary Outcomes
Change from Baseline in Hemoglobin A1c (HbA1c) (%)
Time Frame: Baseline, Week 80
Secondary Outcomes
- 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)
- 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)
Investigators
Study Sites (77)
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