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)

Diabetes Type 2 Clinical Trial

Official title:

A Phase 3, Randomized, Multicenter, Double-Blind Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06354660
• Other study ID #: 18804
• Secondary ID: J1I-MC-GZBY
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 2024
• Est. completion date: July 2026

Study information

• Verified date: April 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 480
• Est. completion date: July 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

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) <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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Type 2

Intervention

Drug:
• Retatrutide
Administered SC.
• Placebo
Administered SC.

Locations

Country	Name	City	State
India	Gujarat Endocrin Pvt Ltd	Ahmedabad	Gujarat
India	Victoria Hospital, Bangalore Medical College And Research Institute	Bangalore	Karnataka
India	S C B Medical College and Hospital	Cuttack	Odisha
India	Eternal Heart Care Center and Research Institute	Jaipur	Rajasthan
India	Brij Medical Centre Private Limited	Kanpur	Uttar Pradesh
India	Government Medical College - Kozhikode	Kozhikode	Kerala
India	All India Institute of Medical Sciences	Raipur	Chhattisgarh
India	Nirmal Hospital	Surat	Gujarat
Mexico	Instituto Jalisciense de Investigacion en Diabetes y Obesidad	Guadalajara	Jalisco
Mexico	Medical Care and Research SA de CV	Merida	Yucatán
Mexico	EME RED Hospitalaria	Mérida	Yucatán
Mexico	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Mexico City	Distrito Federal
Mexico	Centro de investigación y control metabólico	Monterrey	Nuevo León
Mexico	Clínica García Flores SC	Monterrey	Nuevo León
Mexico	Unidad biomedica avanzada monterrey	Monterrey	Nuevo León
Mexico	Grupo Ollin Care	Pachuca	Hidalgo
Mexico	Arké SMO S.A de C.V	Veracruz
Puerto Rico	Dorado Medical Complex	Dorado
Puerto Rico	Ponce Medical School Foundation Inc.	Ponce
United States	San Fernando Valley Health Institute	Canoga Park	California
United States	Delricht Research - Tobias Gadson Boulevard - Charleston	Charleston	South Carolina
United States	MultiCare Rockwood Cheney Clinic	Cheney	Washington
United States	Clinical Research Professionals	Chesterfield	Missouri
United States	Dallas Diabetes Research Center	Dallas	Texas
United States	Providence Health Partners-Center for Clinical Research	Dayton	Ohio
United States	NECCR PrimaCare Research	Fall River	Massachusetts
United States	Northeast Research Institute (NERI)	Fleming Island	Florida
United States	Prime Revival Research Institute	Flower Mound	Texas
United States	Valley Institute of Research - Fort Worth	Fort Worth	Texas
United States	NJ MedCare & NJ Heart	Linden	New Jersey
United States	Ark Clinical Research	Long Beach	California
United States	Manassas Clinical Research Center	Manassas	Virginia
United States	Trinity Research Centers	Marietta	Georgia
United States	Lifedoc Research - Lenox Park Drive	Memphis	Tennessee
United States	Ezy Medical Research	Miami	Florida
United States	Boeson Research MSO	Missoula	Montana
United States	Clinical Research Associates Inc	Nashville	Tennessee
United States	Clinical Research of Philadelphia	Philadelphia	Pennsylvania
United States	Eastside Research Associates	Redmond	Washington
United States	Scottsdale Clinical Trials	Scottsdale	Arizona
United States	Cotton O'Neil Clinical Research Center - Central Office	Topeka	Kansas
United States	Tucson Clinical Research Institute	Tucson	Arizona
United States	Preferred Primary Care Physicians	Uniontown	Pennsylvania
United States	Texas Valley Clinical Research	Weslaco	Texas
United States	Accellacare - Wilmington - 1917 Tradd Court	Wilmington	North Carolina
United States	Clinical Research of Central Florida	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  India,  Mexico,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Hemoglobin A1c (HbA1c) (%)		Baseline, Week 40
Secondary	Percentage of Participants Who Achieve HbA1c < 7.0%		Week 40
Secondary	Percentage of Participants Who Achieve HbA1c = 6.5%		Week 40
Secondary	Percentage of Participants Who Achieve HbA1c < 5.7%		Week 40
Secondary	Change from Baseline in Fasting Serum Glucose		Baseline, Week 40
Secondary	Percent Change from Baseline in Body Weight		Baseline, Week 40
Secondary	Change from Baseline in Body Weight		Baseline, Week 40
Secondary	Percentage of Participants Who Achieve Weight Reduction of = 5%		Week 40
Secondary	Percentage of Participants Who Achieve Weight Reduction of = 10%		Week 40
Secondary	Percentage of Participants Who Achieve Weight Reduction of = 15%		Week 40
Secondary	Percentage of Participants Who Achieve HbA1c = 6.5% and = 10% Weight Reduction		Week 40
Secondary	Percent Change from Baseline in Triglycerides		Baseline, Week 40
Secondary	Percent Change from Baseline in Non- High-Density Lipoprotein (HDL) Cholesterol		Baseline, Week 40
Secondary	Change from Baseline in Systolic Blood Pressure (SBP)		Baseline, Week 40

External 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)