Clinical trial NCT06354660: 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)
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Diabetes Type 2
Keywords: Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-04-09
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in Hemoglobin A1c (HbA1c) (%)
timeFrame: Baseline, Week 40
Secondary outcomes:
measure: Percentage of Participants Who Achieve HbA1c < 7.0%
timeFrame: Week 40
measure: Percentage of Participants Who Achieve HbA1c ≤ 6.5%
timeFrame: Week 40
measure: Percentage of Participants Who Achieve HbA1c < 5.7%
timeFrame: Week 40
measure: Change from Baseline in Fasting Serum Glucose
timeFrame: Baseline, Week 40
measure: Percent Change from Baseline in Body Weight
timeFrame: Baseline, Week 40
measure: Change from Baseline in Body Weight
timeFrame: Baseline, Week 40
measure: Percentage of Participants Who Achieve Weight Reduction of ≥ 5%
timeFrame: Week 40
measure: Percentage of Participants Who Achieve Weight Reduction of ≥ 10%
timeFrame: Week 40
measure: Percentage of Participants Who Achieve Weight Reduction of ≥ 15%
timeFrame: Week 40
measure: Percentage of Participants Who Achieve HbA1c ≤ 6.5% and ≥ 10% Weight Reduction
timeFrame: Week 40
measure: Percent Change from Baseline in Triglycerides
timeFrame: Baseline, Week 40
measure: Percent Change from Baseline in Non- High-Density Lipoprotein (HDL) Cholesterol
timeFrame: Baseline, Week 40
measure: Change from Baseline in Systolic Blood Pressure (SBP)
timeFrame: Baseline, Week 40
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Clinical Trials
state: Arizona
city: Tucson
country: United States
facility: Tucson Clinical Research Institute
state: Arizona
city: Canoga Park
country: United States
facility: San Fernando Valley Health Institute
state: California
city: Long Beach
country: United States
facility: Ark Clinical Research
state: California
city: Fleming Island
country: United States
facility: Northeast Research Institute (NERI)
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Miami
country: United States
facility: Ezy Medical Research
state: Florida
city: Winter Haven
country: United States
facility: Clinical Research of Central Florida
state: Florida
city: Marietta
country: United States
facility: Trinity Research Centers
state: Georgia
city: Topeka
country: United States
facility: Cotton O'Neil Clinical Research Center
state: Kansas
city: Fall River
country: United States
facility: NECCR PrimaCare Research
state: Massachusetts
city: Chesterfield
country: United States
facility: Clinical Research Professionals
state: Missouri
city: Missoula
country: United States
facility: Boeson Research MSO
state: Montana
city: Linden
country: United States
facility: NJ MedCare & NJ Heart
state: New Jersey
city: Wilmington
country: United States
facility: Accellacare - Wilmington - 1917 Tradd Court
state: North Carolina
city: Dayton
country: United States
facility: Providence Health Partners-Center for Clinical Research
state: Ohio
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia
state: Pennsylvania
city: Uniontown
country: United States
facility: Preferred Primary Care Physicians
state: Pennsylvania
city: Charleston
country: United States
facility: Delricht Research - Tobias Gadson Boulevard - Charleston
state: South Carolina
city: Memphis
country: United States
facility: Lifedoc Research - Lenox Park Drive
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates Inc
state: Tennessee
city: Dallas
country: United States
facility: Velocity Clinical Research, Dallas
state: Texas
city: Flower Mound
country: United States
facility: Prime Revival Research Institute, LLC
state: Texas
city: Fort Worth
country: United States
facility: Valley Institute of Research - Fort Worth
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Weslaco
country: United States
facility: Texas Valley Clinical Research
state: Texas
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
city: Cheney
country: United States
facility: MultiCare Rockwood Cheney Clinic
state: Washington
city: Redmond
country: United States
facility: Eastside Research Associates
state: Washington
city: Raipur
country: India
facility: All India Institute of Medical Sciences
state: Chhattisgarh
city: Ahmedabad
country: India
facility: Gujarat Endocrin Pvt Ltd
state: Gujarat
city: Surat
country: India
facility: Nirmal Hospital Pvt Ltd.
state: Gujarat
city: Bangalore
country: India
facility: Victoria Hospital, Bangalore Medical College And Research Institute
state: Karnataka
city: Kozhikode
country: India
facility: Government Medical College - Kozhikode
state: Kerala
city: Bhubaneswar
country: India
facility: All India Institute of Medical Sciences
state: Odisha
city: Jaipur
country: India
facility: Eternal Heart Care Center and Research Institute
state: Rajasthan
city: Kanpur
country: India
facility: Brij Medical Centre Private Limited
state: Uttar Pradesh
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
state: Distrito Federal
city: Pachuca
country: Mexico
facility: Grupo Ollin Care
state: Hidalgo
city: Guadalajara
country: Mexico
facility: Instituto Jalisciense de Investigacion en Diabetes y Obesidad
state: Jalisco
city: Monterrey
country: Mexico
facility: Unidad biomedica avanzada monterrey
state: Nuevo León
city: Monterrey
country: Mexico
facility: Clínica García Flores SC
state: Nuevo León
city: San Nicolás de los Garza
country: Mexico
facility: Centro de investigación y control metabólico
state: Nuevo León
city: Merida
country: Mexico
facility: Medical Care and Research SA de CV
state: Yucatán
city: Mérida
country: Mexico
facility: EME RED Hospitalaria
state: Yucatán
city: Veracruz
country: Mexico
facility: Arké SMO S.A de C.V
city: Dorado
country: Puerto Rico
facility: Dorado Medical Complex
city: Ponce
country: Puerto Rico
facility: Ponce Medical School Foundation Inc.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: