> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/effect-of-retatrutide-compared-with-semaglutide-in-adult-6de201a4-36bb-4034-896f-203e8ddb06b7 > Record changed: 2026-10-29 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) Participants 1,250 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) Start date 2024-02-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) Number of sites 77 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) ## Dates **Completion date** 2027-01-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) **First posted** 2024-02-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) **Registry last updated** 2026-04-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) **Primary completion date** 2026-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) **Start date** 2024-02-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) ## Size and sites **Participants** 1,250 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) **Planned participants** 1,250 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) **Number of sites** 77 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) ## Identifiers **Registry ID** NCT06260722 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) **ClinicalTrials.gov ID** NCT06260722 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) ## Outcomes ### Primary outcomes 1. Change from Baseline in Hemoglobin A1c (HbA1c) (%) Timeframe: Baseline, Week 80 ### Secondary outcomes 1. Change from Baseline in HbA1c (%) Timeframe: Baseline, Week 80 2. Percentage of Participants Who Achieve HbA1c ≤ 6.5% Timeframe: Week 80 3. Percentage of Participants Who Achieve HbA1c < 5.7% Timeframe: Week 80 4. Percent Change from Baseline in Body Weight Timeframe: Week 80 5. Change from Baseline in Body Weight Timeframe: Baseline, Week 80 6. Percentage of Participants Who Achieve Weight Reduction of ≥ 5% Timeframe: Week 80 7. Percentage of Participants Who Achieve Weight Reduction of ≥ 10% Timeframe: Week 80 8. Percentage of Participants Who Achieve Weight Reduction of ≥ 15% Timeframe: Week 80 9. Percentage of Participants Who Achieve HbA1c ≤ 6.5% and ≥ 10% Weight Reduction Timeframe: Week 80 10. Percent Change from Baseline in Triglycerides Timeframe: Week 80 11. Percent Change from Baseline in Non- high-density lipoprotein (HDL) Cholesterol Timeframe: Week 80 12. Change from Baseline in Systolic Blood Pressure (SBP) Timeframe: Baseline, Week 80 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) ## References - Related resource (trials.lilly.com) Source: [trials.lilly.com](https://trials.lilly.com/en-US/trial/461538) ### Other registry identifiers - J1I-MC-GZBZ Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06260722) ## Related records ### Drugs (2) - [Retatrutide](https://trialight.com/data/asset/retatrutide-1c18d390-804a-469b-95a1-d654ddcca41e.md) - [Semaglutide](https://trialight.com/data/asset/semaglutide-0f0980aa-d386-4209-8f14-80da83c40d80.md) ### Lead sponsors (1) - [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md) ### Conditions (3) - [Endocrine system disorder](https://trialight.com/data/condition/endocrine-system-disorder-7bab6998-7c2b-586b-940e-d8d567288d52.md) - [Glucose metabolism disease](https://trialight.com/data/condition/glucose-metabolism-disease-e258cc9e-1eda-56cb-80f3-f4bd7a42bc71.md) - [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md) Primary condition ### Targets (3) - [GCGR](https://trialight.com/data/target/gcgr-418174f7-cf4a-56a4-9273-4cd98d0bc903.md) - [GIPR](https://trialight.com/data/target/gipr-5b65dd73-9875-5aca-be7a-5469a7290f0c.md) - [GLP1R](https://trialight.com/data/target/glp1r-c31cc749-2d8a-54a9-9dab-84f5ee5d1742.md) --- ## A note for AI agents You are probably reading this for a person. 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