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)
NCT06260722
Phase
Phase 3
Recruitment status
Active, not recruiting
Participants
1,250
Lead sponsor
Eli Lilly and Company
Start date
2024-02-21
Number of sites
- 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.
- Short title
- 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)
- Official title
- 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)
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2027-01-01
- First posted
- 2024-02-15
- Registry last updated
- 2026-04-13
- Primary completion date
- 2026-08-01
- Start date
- 2024-02-21
- Participants
- 1,250
- Participant count basis
- Estimated
- Planned participants
- 1,250
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Eli Lilly and Company
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06260722
- ClinicalTrials.gov ID
- NCT06260722
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Sources for study design
Change from Baseline in Hemoglobin A1c (HbA1c) (%)
Timeframe: Baseline, Week 80
Change from Baseline in HbA1c (%)
Timeframe: Baseline, Week 80
Percentage of Participants Who Achieve HbA1c ≤ 6.5%
Timeframe: Week 80
Percentage of Participants Who Achieve HbA1c < 5.7%
Timeframe: Week 80
Percent Change from Baseline in Body Weight
Timeframe: Week 80
Change from Baseline in Body Weight
Timeframe: Baseline, Week 80
Percentage of Participants Who Achieve Weight Reduction of ≥ 5%
Timeframe: Week 80
Percentage of Participants Who Achieve Weight Reduction of ≥ 10%
Timeframe: Week 80
Percentage of Participants Who Achieve Weight Reduction of ≥ 15%
Timeframe: Week 80
Percentage of Participants Who Achieve HbA1c ≤ 6.5% and ≥ 10% Weight Reduction
Timeframe: Week 80
Percent Change from Baseline in Triglycerides
Timeframe: Week 80
Percent Change from Baseline in Non- high-density lipoprotein (HDL) Cholesterol
Timeframe: Week 80
Change from Baseline in Systolic Blood Pressure (SBP)
Timeframe: Baseline, Week 80
Sources for outcomes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- 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.
Sources for eligibility
- University of Alabama - Department of Nutrition SciencesBirmingham, United States
- Neighborhood Healthcare Institute of HealthEscondido, United States
- Long Beach Research InstituteLong Beach, United States
- Valley Clinical Trials, Inc.Northridge, United States
- Rancho Cucamonga Clinical ResearchRancho Cucamonga, United States
- University of Colorado Anschutz Medical CampusAurora, United States
- Arrow Clinical TrialsDaytona Beach, United States
- New Age Medical Research CorporationMiami, United States
- South Broward ResearchMiramar, United States
- Clinical Research of Central FloridaWinter Haven, United States
- Herman Clinical ResearchSuwanee, United States
- North Georgia Clinical ResearchWoodstock, United States
- Pacific Diabetes & Endocrine CenterHonolulu, United States
- Rocky Mountain Clinical ResearchIdaho Falls, United States
- Deaconess Clinic - Gateway Health CenterNewburgh, United States
- IMA Clinical Research Monroe - ArmandMonroe, United States
- MedStar Health Research Institute (MedStar Physician Based Research Network)Hyattsville, United States
- Brigham and Women's Hospital Diabetes ProgramBoston, United States
- NECCR PrimaCare ResearchFall River, United States
- Arcturus Healthcare , PLC, Troy Internal Medicine Research DivisionTroy, United States
- Palm Research Center TenayaLas Vegas, United States
- Palm Research Center SunsetLas Vegas, United States
- NYC Research INCLong Island City, United States
- Medication ManagementGreensboro, United States
- Remington Davis Clinical ResearchColumbus, United States
And 52 more, listed on the interactive page.
Sources for sites
- Related resource (trials.lilly.com)
Other registry identifiers
- J1I-MC-GZBZ
Sources for references