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)

Running, not enrolling · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT06260722

Run by

Eli Lilly and Company

People needed

1250

Starts

2024-02-21

Expected to finish

2027-01-01

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• 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
• Herman Clinical Research — Suwanee, Georgia, United States
• North Georgia Clinical Research — Woodstock, Georgia, United States
• Pacific Diabetes & Endocrine Center — Honolulu, Hawaii, United States
• Rocky Mountain Clinical Research — Idaho Falls, Idaho, United States
• Deaconess Clinic - Gateway Health Center — Newburgh, Indiana, United States
• IMA Clinical Research Monroe - Armand — Monroe, Louisiana, United States
• MedStar Health Research Institute (MedStar Physician Based Research Network) — Hyattsville, Maryland, United States
• Brigham and Women's Hospital Diabetes Program — Boston, Massachusetts, United States
• NECCR PrimaCare Research — Fall River, Massachusetts, United States
• Arcturus Healthcare , PLC, Troy Internal Medicine Research Division — Troy, Michigan, United States
• Palm Research Center Tenaya — Las Vegas, Nevada, United States
• Palm Research Center Sunset — Las Vegas, Nevada, United States
• NYC Research INC — Long Island City, New York, United States
• Medication Management — Greensboro, North Carolina, United States
• Remington Davis Clinical Research — Columbus, Ohio, United States
• University of Alabama - Department of Nutrition Sciences — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.