Clinical trial NCT06297603: Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Glycemic Control on Basal Insulin, With or Without Metformin and/or SGLT2 Inhibitor (TRANSCEND-T2D-3)
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, Moderate or Severe Renal Impairment With Inadequate Glycemic Control on Basal Insulin With or Without Metformin and/or SGLT2 Inhibitor
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Disease
Renal Insufficiency Chronic
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-03-07
Enrollment: 320
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 renal impairment, with inadequate glycemic control on basal insulin alone or a combination of basal insulin with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study will last about 14 months and may include up to 22 visits.


Eligibility criteria: Inclusion Criteria:

* Have Type 2 Diabetes (T2D)
* Have HbA1c ≥7.0% (53 millimoles per mole (mmol/mol)) to ≤10.5% (91 mmol/mol)
* Have moderate or severe renal impairment
* Have been on the following stable diabetes treatment during 90 days prior to screening

  * basal insulin (≥20 International Units (IU)/day) with or without
  * metformin and/or SGLT2 inhibitor
* 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/m2)

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 a history of unstable or rapidly progressing renal disease
* Have a prior or planned surgical treatment for obesity
* Have New York Heart Association Functional Classification III or IV congestive heart failure
* Have had 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 a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2.
* Have any lifetime history of a suicide attempt
* Had chronic or acute pancreatitis
* 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 52
Secondary outcomes:
measure: Percentage of Participants Achieving HbA1c <7.0%
timeFrame: Week 52
measure: Percentage of Participants Achieving HbA1c ≤6.5%
timeFrame: Week 52
measure: Change from Baseline in Fasting Serum Glucose
timeFrame: Baseline, Week 52
measure: Percentage of Time Continuous Glucose Monitoring (CGM) Glucose Values are Between 70 and 180 mg/dL
timeFrame: Week 52
measure: Percent Change from Baseline in Body Weight
timeFrame: Baseline, Week 52
measure: Change from Baseline in Body Weight
timeFrame: Baseline, Week 52
measure: Percentage of Participants Achieving Weight Reduction of ≥5%
timeFrame: Week 52
measure: Percentage of Participants Achieving Weight Reduction of ≥10%
timeFrame: Week 52
measure: Percentage of Participants Achieving Weight Reduction of ≥15%
timeFrame: Week 52
measure: Percentage of Participants Achieving HbA1c ≤6.5% and ≥10% Weight Reduction
timeFrame: Week 52
measure: Percent Change from Baseline in Non-HDL Cholesterol
timeFrame: Baseline, Week 52
measure: Percent Change from Baseline in Triglycerides
timeFrame: Baseline, Week 52
measure: Change from Baseline in Systolic Blood Pressure (SBP)
timeFrame: Baseline, Week 52
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Nephrology Consultants
state: Alabama
city: Sun City West
country: United States
facility: Clinical Research Institute of Arizona (CRI) - Sun City West
state: Arizona
city: Apple Valley
country: United States
facility: Kidney & Hypertension Center - Apple Valley
state: California
city: Canoga Park
country: United States
facility: Hope Clinical Research, Inc.
state: California
city: Escondido
country: United States
facility: Neighborhood Healthcare Institute of Health
state: California
city: La Mesa
country: United States
facility: EndoTrials Center for Clinical Research
state: California
city: Torrance
country: United States
facility: UCLA South Bay Endocrinology
state: California
city: Fleming Island
country: United States
facility: Northeast Research Institute (NERI)
state: Florida
city: Weston
country: United States
facility: Encore Medical Research - Weston
state: Florida
city: Decatur
country: United States
facility: Orita Clinical Research
state: Georgia
city: Idaho Falls
country: United States
facility: Care Research
state: Idaho
city: Topeka
country: United States
facility: Cotton O'Neil Diabetes & Endocrinology
state: Kansas
city: Billings
country: United States
facility: Billings Clinic
state: Montana
city: Las Vegas
country: United States
facility: Excel Clinical Research, LLC
state: Nevada
city: Albany
country: United States
facility: Albany Medical College, Division of Community Endocrinology
state: New York
city: Long Island City
country: United States
facility: NYC Research INC
state: New York
city: Williamsville
country: United States
facility: Research Foundation of SUNY - University of Buffalo
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Medical Center
state: North Carolina
city: Hickory
country: United States
facility: Lucas Research, Inc.
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Tulsa
country: United States
facility: Central States Research
state: Oklahoma
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
state: Pennsylvania
city: Bartlett
country: United States
facility: AM Diabetes & Endocrinology Center
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: Houston
country: United States
facility: Juno Research
state: Texas
city: Houston
country: United States
facility: PlanIt Research, PLLC
state: Texas
city: Mesquite
country: United States
facility: Southern Endocrinology Associates
state: Texas
city: Weslaco
country: United States
facility: Texas Valley Clinical Research
state: Texas
city: Sandy
country: United States
facility: Diabetes & Endocrine Treatment Specialists
state: Utah
city: Caba
country: Argentina
facility: CEDIC
state: Buenos Aires
city: Lanus
country: Argentina
facility: CIMeL
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Centro de Investigaciones Médicas Mar del Plata
state: Buenos Aires
city: Ramos Mejía
country: Argentina
facility: DIM Clínica Privada
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Investigaciones Medicas Imoba Srl
state: Ciudad Autónoma De Buenos Aires
city: Buenos Aires
country: Argentina
facility: CIPREC
state: Ciudad Autónoma De Buenos Aires
city: Buenos Aires
country: Argentina
facility: Centro Médico Viamonte
state: Ciudad Autónoma De Buenos Aires
city: Buenos Aires
country: Argentina
facility: Mautalen Salud e Investigación
state: Ciudad Autónoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
state: Ciudad Autónoma De Buenos Aires
city: Granadero Baigorria
country: Argentina
facility: Centro de Investigaciones Clínicas Baigorria
state: Santa Fe
city: Rosario
country: Argentina
facility: INECO Neurociencias Oroño
state: Santa Fe
city: Rosario
country: Argentina
facility: Instituto Médico Catamarca IMEC
state: Santa Fe
city: Rosario
country: Argentina
facility: Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
state: Santa Fe
city: Rosario
country: Argentina
facility: Instituto de Investigaciones Clinicas Rosario
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: CIPREC
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
city: Córdoba
country: Argentina
facility: Centro Diabetológico Dr. Waitman
city: Córdoba
country: Argentina
facility: Centro Médico Colón
city: Maceio
country: Brazil
facility: Centro de Pesquisas Clínicas Dr. Marco Mota
state: Alagoas
city: Fortaleza
country: Brazil
facility: Instituto de Ensino e Pesquisa Clinica do Ceara
state: Ceará
city: Vitória
country: Brazil
facility: CEDOES
state: Espírito Santo
city: Curitiba
country: Brazil
facility: Centro de Diabetes Curitiba
state: Paraná
city: Santo Andre
country: Brazil
facility: Praxis Pesquisa Medica
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Instituto de Pesquisa Clinica
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: IBPClin - Instituto Brasil de Pesquisa Clínica
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center
state: HaDarom
city: Herzliya
country: Israel
facility: Institute of Diabetes, Technology and Research - Clalit Health
state: HaMerkaz
city: Holon
country: Israel
facility: Edith Wolfson Medical Center
state: HaMerkaz
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
state: HaMerkaz
city: Atlit
country: Israel
facility: Clalit Health Services - Atlit
state: HaTsafon
city: Sakhnin
country: Israel
facility: Clalit Health Services - Sakhnin Community Clinic
state: HaTsafon
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
state: Yerushalayim
city: Haifa
country: Israel
facility: Rambam Health Care Campus
state: Ḥeifā
city: Guadalajara
country: Mexico
facility: Diseno y Planeacion en Investigacion Medica
state: Jalisco
city: Merida
country: Mexico
facility: Medical Care and Research SA de CV
state: Yucatán
city: Chihuahua
country: Mexico
facility: Enclifar Ensayos Clínicos Farmacológicos Sc
city: Mexico
country: Mexico
facility: Instituto Nacional de Cardiologia Ignacio Chavez
city: Veracruz
country: Mexico
facility: FAICIC S. de R.L. de C.V.
city: Bayamon
country: Puerto Rico
facility: Centro de Endocrinologia Alcantara Gonzalez
city: Guaynabo
country: Puerto Rico
facility: Isis Clinical Research Center
city: San Juan
country: Puerto Rico
facility: Mgcendo Llc
city: Bristol
country: United Kingdom
facility: Southmead Hospital
state: Bristol, City Of
city: Preston
country: United Kingdom
facility: Panthera Biopartners - Preston
state: England
city: Truro
country: United Kingdom
facility: The Royal Cornwall Hospital
state: England
city: Stevenage
country: United Kingdom
facility: Lister Hospital
state: Hertfordshire
city: Rochdale
country: United Kingdom
facility: Panthera Biopartners - Manchester
state: Manchester
city: Salford
country: United Kingdom
facility: Salford Royal Hospital
state: Manchester
city: Edinburgh
country: United Kingdom
facility: Edinburgh Royal Infirmary
state: Midlothian
city: Glasgow
country: United Kingdom
facility: Panthera Biopartners - Glasgow
state: Scotland
city: Nuneaton
country: United Kingdom
facility: George Eliot Hospital
state: Warwickshire
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: