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)
- Registration Number
- NCT06297603
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 320
-
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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Retatrutide Dose 2 Retatrutide Participants will receive retatrutide administered SC. Retatrutide Dose 3 Retatrutide Participants will receive retatrutide administered SC. Retatrutide Dose 1 Retatrutide Participants will receive retatrutide administered subcutaneously (SC). Placebo Placebo Participants will receive placebo administered SC.
- Primary Outcome Measures
Name Time Method Change from Baseline in Hemoglobin A1c (HbA1c) (%) Baseline, Week 52
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving HbA1c <7.0% Week 52 Percentage of Participants Achieving HbA1c ≤6.5% Week 52 Change from Baseline in Fasting Serum Glucose Baseline, Week 52 Percentage of Time Continuous Glucose Monitoring (CGM) Glucose Values are Between 70 and 180 mg/dL Week 52 Measured during the CGM session that occurs during 30 days prior to Week 52
Percent Change from Baseline in Body Weight Baseline, Week 52 Change from Baseline in Body Weight Baseline, Week 52 Percentage of Participants Achieving Weight Reduction of ≥5% Week 52 Percentage of Participants Achieving Weight Reduction of ≥10% Week 52 Percentage of Participants Achieving Weight Reduction of ≥15% Week 52 Percentage of Participants Achieving HbA1c ≤6.5% and ≥10% Weight Reduction Week 52 Percent Change from Baseline in Non-HDL Cholesterol Baseline, Week 52 Percent Change from Baseline in Triglycerides Baseline, Week 52 Change from Baseline in Systolic Blood Pressure (SBP) Baseline, Week 52
Trial Locations
- Locations (80)
Nephrology Consultants
🇺🇸Huntsville, Alabama, United States
Clinical Research Institute of Arizona (CRI) - Sun City West
🇺🇸Sun City West, Arizona, United States
Kidney & Hypertension Center - Apple Valley
🇺🇸Apple Valley, California, United States
Hope Clinical Research, Inc.
🇺🇸Canoga Park, California, United States
Neighborhood Healthcare Institute of Health
🇺🇸Escondido, California, United States
EndoTrials Center for Clinical Research
🇺🇸La Mesa, California, United States
UCLA South Bay Endocrinology
🇺🇸Torrance, California, United States
Northeast Research Institute (NERI)
🇺🇸Fleming Island, Florida, United States
Encore Medical Research - Weston
🇺🇸Weston, Florida, United States
Orita Clinical Research
🇺🇸Decatur, Georgia, United States
Care Research
🇺🇸Idaho Falls, Idaho, United States
Cotton O'Neil Diabetes & Endocrinology
🇺🇸Topeka, Kansas, United States
Billings Clinic
🇺🇸Billings, Montana, United States
Excel Clinical Research, LLC
🇺🇸Las Vegas, Nevada, United States
Sierra Nevada Specialty Care
🇺🇸Reno, Nevada, United States
Albany Medical College, Division of Community Endocrinology
🇺🇸Albany, New York, United States
NYC Research INC
🇺🇸Long Island City, New York, United States
Research Foundation of SUNY - University of Buffalo
🇺🇸Williamsville, New York, United States
University of North Carolina Medical Center
🇺🇸Chapel Hill, North Carolina, United States
Lucas Research, Inc.
🇺🇸Hickory, North Carolina, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Central States Research
🇺🇸Tulsa, Oklahoma, United States
Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
🇺🇸Pittsburgh, Pennsylvania, United States
AM Diabetes & Endocrinology Center
🇺🇸Bartlett, Tennessee, United States
Velocity Clinical Research, Dallas
🇺🇸Dallas, Texas, United States
Prime Revival Research Institute, LLC
🇺🇸Flower Mound, Texas, United States
Juno Research
🇺🇸Houston, Texas, United States
PlanIt Research, PLLC
🇺🇸Houston, Texas, United States
Southern Endocrinology Associates
🇺🇸Mesquite, Texas, United States
Texas Valley Clinical Research
🇺🇸Weslaco, Texas, United States
Diabetes & Endocrine Treatment Specialists
🇺🇸Sandy, Utah, United States
CEDIC
🇦🇷Caba, Buenos Aires, Argentina
CIMeL
🇦🇷Lanus, Buenos Aires, Argentina
Centro de Investigaciones Médicas Mar del Plata
🇦🇷Mar del Plata, Buenos Aires, Argentina
DIM Clínica Privada
🇦🇷Ramos Mejía, Buenos Aires, Argentina
Investigaciones Medicas Imoba Srl
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
CIPREC
🇦🇷Buenos Aires, Argentina
Centro Médico Viamonte
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Mautalen Salud e Investigación
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
🇦🇷Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Centro de Investigaciones Clínicas Baigorria
🇦🇷Granadero Baigorria, Santa Fe, Argentina
INECO Neurociencias Oroño
🇦🇷Rosario, Santa Fe, Argentina
Instituto Médico Catamarca IMEC
🇦🇷Rosario, Santa Fe, Argentina
Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
🇦🇷Rosario, Santa Fe, Argentina
Instituto de Investigaciones Clinicas Rosario
🇦🇷Rosario, Santa Fe, Argentina
Centro de Investigaciones Metabólicas (CINME)
🇦🇷Ciudad Autónoma de Buenos Aires, Argentina
Centro Diabetológico Dr. Waitman
🇦🇷Córdoba, Argentina
Centro Médico Colón
🇦🇷Córdoba, Argentina
Centro de Pesquisas Clínicas Dr. Marco Mota
🇧🇷Maceio, Alagoas, Brazil
Instituto de Ensino e Pesquisa Clinica do Ceara
🇧🇷Fortaleza, Ceará, Brazil
CEDOES
🇧🇷Vitória, Espírito Santo, Brazil
Centro de Diabetes Curitiba
🇧🇷Curitiba, Paraná, Brazil
Praxis Pesquisa Medica
🇧🇷Santo Andre, São Paulo, Brazil
Instituto de Pesquisa Clinica
🇧🇷Sao Paulo, São Paulo, Brazil
IBPClin - Instituto Brasil de Pesquisa Clínica
🇧🇷Rio de Janeiro, Brazil
Soroka Medical Center
🇮🇱Be'er Sheva, HaDarom, Israel
Institute of Diabetes, Technology and Research - Clalit Health
🇮🇱Herzliya, HaMerkaz, Israel
Edith Wolfson Medical Center
🇮🇱Holon, HaMerkaz, Israel
Sheba Medical Center
🇮🇱Ramat Gan, HaMerkaz, Israel
Clalit Health Services - Atlit
🇮🇱Atlit, HaTsafon, Israel
Clalit Health Services - Sakhnin Community Clinic
🇮🇱Sakhnin, HaTsafon, Israel
Hadassah Medical Center
🇮🇱Jerusalem, Yerushalayim, Israel
Rambam Health Care Campus
🇮🇱Haifa, Ḥeifā, Israel
Diseno y Planeacion en Investigacion Medica
🇲🇽Guadalajara, Jalisco, Mexico
Medical Care and Research SA de CV
🇲🇽Merida, Yucatán, Mexico
Enclifar Ensayos Clínicos Farmacológicos Sc
🇲🇽Chihuahua, Mexico
Instituto Nacional de Cardiologia Ignacio Chavez
🇲🇽Mexico, Mexico
FAICIC S. de R.L. de C.V.
🇲🇽Veracruz, Mexico
Centro de Endocrinologia Alcantara Gonzalez
🇵🇷Bayamon, Puerto Rico
Isis Clinical Research Center
🇵🇷Guaynabo, Puerto Rico
Mgcendo Llc
🇵🇷San Juan, Puerto Rico
Southmead Hospital
🇬🇧Bristol, Bristol, City Of, United Kingdom
Panthera Biopartners - Preston
🇬🇧Preston, England, United Kingdom
The Royal Cornwall Hospital
🇬🇧Truro, England, United Kingdom
Lister Hospital
🇬🇧Stevenage, Hertfordshire, United Kingdom
Panthera Biopartners - Manchester
🇬🇧Rochdale, Manchester, United Kingdom
Salford Royal Hospital
🇬🇧Salford, Manchester, United Kingdom
Edinburgh Royal Infirmary
🇬🇧Edinburgh, Midlothian, United Kingdom
Panthera Biopartners - Glasgow
🇬🇧Glasgow, Scotland, United Kingdom
George Eliot Hospital
🇬🇧Nuneaton, Warwickshire, United Kingdom