Effect of Retatrutide Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1)

NCT06354660 | Completed Phase 3 FDA Drug

• 2 other identifiers: 18804J1I-MC-GZBY
• Study Type: interventional
• Target: 537
• Locations: 4 countries
• Sites: 48

Brief Summary

The purpose of this study is to investigate the efficacy and safety of retatrutide compared with placebo in participants with Type 2 Diabetes and inadequate glycemic control. The study will last about 11 months and may include up to 11 visits.

Conditions

Diabetes Type 2

Keywords

Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Hemoglobin A1c (HbA1c) (%)

  Baseline, Week 40

Secondary Outcomes (13)

• Percentage of Participants Who Achieve HbA1c < 7.0%

  Week 40

• Percentage of Participants Who Achieve HbA1c ≤ 6.5%

  Week 40

• Percentage of Participants Who Achieve HbA1c < 5.7%

  Week 40

• Change from Baseline in Fasting Serum Glucose

  Baseline, Week 40

• Percent Change from Baseline in Body Weight

  Baseline, Week 40

Study Arms (4)

Retatrutide Dose Level 1

EXPERIMENTAL

Participants will receive retatrutide administered subcutaneously (SC).

Drug: Retatrutide

Retatrutide Dose Level 2

EXPERIMENTAL

Participants will receive retatrutide administered SC.

Drug: Retatrutide

Retatrutide Dose Level 3

EXPERIMENTAL

Participants will receive retatrutide administered SC.

Drug: Retatrutide

Placebo

PLACEBO COMPARATOR

Participants will receive placebo administered SC.

Drug: Placebo

Interventions

Retatrutide DRUG

Administered SC.

Also known as: LY3437943

Retatrutide Dose Level 1; Retatrutide Dose Level 2; Retatrutide Dose Level 3

Placebo DRUG

Administered SC.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have Type 2 Diabetes (T2D)
• Have HbA1c ≥ 7.0% to ≤ 9.5%
• Are naïve to insulin therapy and have not used oral or injectable antihyperglycemic (diabetes) medication for at least 90 days prior to screening
• Are of stable weight for at least 90 days prior to screening
• Have a Body Mass Index (BMI) ≥ 23.0 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) \<15 milliliters/minute/1.73 meter squared (mL/min/1.73 m\^2) 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (48)

Scottsdale Clinical Trials

Scottsdale, Arizona, 85260, United States

Location

Tucson Clinical Research Institute

Tucson, Arizona, 85712, United States

Location

San Fernando Valley Health Institute

Canoga Park, California, 91304, United States

Location

Ark Clinical Research

Long Beach, California, 90815, United States

Location

Northeast Research Institute (NERI)

Fleming Island, Florida, 32003, United States

Location

New Horizon Research Center

Miami, Florida, 33165, United States

Location

Ezy Medical Research

Miami, Florida, 33175, United States

Location

Clinical Research of Central Florida

Winter Haven, Florida, 33880, United States

Location

Trinity Research Centers

Marietta, Georgia, 30064, United States

Location

Cotton O'Neil Clinical Research Center

Topeka, Kansas, 66606, United States

Location

NECCR PrimaCare Research

Fall River, Massachusetts, 02721, United States

Location

Clinical Research Professionals

Chesterfield, Missouri, 63005, United States

Location

Boeson Research MSO

Missoula, Montana, 59804, United States

Location

NJ MedCare & NJ Heart

Linden, New Jersey, 07036, United States

Location

Accellacare - Wilmington - 1917 Tradd Court

Wilmington, North Carolina, 28401, United States

Location

Providence Health Partners-Center for Clinical Research

Dayton, Ohio, 45439, United States

Location

Clinical Research of Philadelphia

Philadelphia, Pennsylvania, 19114, United States

Location

Preferred Primary Care Physicians

Uniontown, Pennsylvania, 15401, United States

Location

Delricht Research - Tobias Gadson Boulevard - Charleston

Charleston, South Carolina, 29407, United States

Location

Lifedoc Research - Lenox Park Drive

Memphis, Tennessee, 38115, United States

Location

Clinical Research Associates Inc

Nashville, Tennessee, 37203, United States

Location

Velocity Clinical Research, Dallas

Dallas, Texas, 75230, United States

Location

Prime Revival Research Institute, LLC

Flower Mound, Texas, 75028, United States

Location

Valley Institute of Research - Fort Worth

Fort Worth, Texas, 76164, United States

Location

Consano Clinical Research, LLC

Shavano Park, Texas, 78231, United States

Location

Texas Valley Clinical Research

Weslaco, Texas, 78596, United States

Location

Manassas Clinical Research Center

Manassas, Virginia, 20110, United States

Location

MultiCare Rockwood Cheney Clinic

Cheney, Washington, 99004, United States

Location

Eastside Research Associates

Redmond, Washington, 98052, United States

Location

All India Institute of Medical Sciences

Raipur, Chhattisgarh, 492099, India

Location

Gujarat Endocrin Pvt Ltd

Ahmedabad, Gujarat, 380052, India

Location

Nirmal Hospital Pvt Ltd.

Surat, Gujarat, 395002, India

Location

Victoria Hospital, Bangalore Medical College And Research Institute

Bangalore, Karnataka, 560002, India

Location

Government Medical College - Kozhikode

Kozhikode, Kerala, 673008, India

Location

All India Institute of Medical Sciences

Bhubaneswar, Odisha, 751019, India

Location

Eternal Heart Care Center and Research Institute

Jaipur, Rajasthan, 302020, India

Location

Brij Medical Centre Private Limited

Kanpur, Uttar Pradesh, 208020, India

Location

Grupo Ollin Care

Pachuca, Hidalgo, 42000, Mexico

Location

Instituto Jalisciense de Investigacion en Diabetes y Obesidad

Guadalajara, Jalisco, 04460, Mexico

Location

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, Mexico City, 14080, Mexico

Location

Unidad biomedica avanzada monterrey

Monterrey, Nuevo León, 64460, Mexico

Location

Clínica García Flores SC

Monterrey, Nuevo León, 64610, Mexico

Location

Centro de investigación y control metabólico

San Nicolás de los Garza, Nuevo León, 66465, Mexico

Location

EME RED Hospitalaria

Mérida, Yucatán, 97000, Mexico

Location

Medical Care and Research SA de CV

Mérida, Yucatán, 97070, Mexico

Location

Arké SMO S.A de C.V

Veracruz, 91910, Mexico

Location

Dorado Medical Complex

Dorado, 00646, Puerto Rico

Location

Ponce Medical School Foundation Inc.

Ponce, 00716, Puerto Rico

Location

Related Links

• Effect of Retatrutide Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1)

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Interventions

retatrutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Nutritional and Metabolic Diseases

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 9, 2024
• Study Start: April 10, 2024
• Primary Completion: January 22, 2026
• Study Completion: February 20, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

PR (2); US (29); ME (9); IN (8)