ACTIVE_NOT_RECRUITING

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)

Description

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 Overview

Study Details

Study overview

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.

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)

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)

Condition
Diabetes Mellitus, Type 2
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama - Department of Nutrition Sciences, Birmingham, Alabama, United States, 35294

Escondido

Neighborhood Healthcare Institute of Health, Escondido, California, United States, 92025

Long Beach

Long Beach Research Institute, Long Beach, California, United States, 90805

Northridge

Valley Clinical Trials, Inc., Northridge, California, United States, 91325

Rancho Cucamonga

Rancho Cucamonga Clinical Research, Rancho Cucamonga, California, United States, 91730

Aurora

University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States, 80045

Daytona Beach

Arrow Clinical Trials, Daytona Beach, Florida, United States, 32117

Miami

New Age Medical Research Corporation, Miami, Florida, United States, 33186

Miramar

South Broward Research, Miramar, Florida, United States, 33027

Winter Haven

Clinical Research of Central Florida, Winter Haven, Florida, United States, 33880

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2027-03