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O estudo clínico NCT06297603 para Diabetes tipo 2 está ativo, não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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Eli LillyEffect 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) Fase III 320
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O estudo clínico NCT06297603 procura avaliar tratamento para Diabetes tipo 2. Este é um estudo intervencionista de Fase III. Seu status atual é: ativo, não recrutando. O estudo começou em 15 de março de 2024 e pretende incluir 320 participantes. Coordenado por Eli Lilly e deve ser concluído em 1 de novembro de 2026. Essas informações foram atualizadas no ClinicalTrials.gov em 24 de dezembro de 2025.
Resumo
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.
Título oficial
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
Condições médicas
Diabetes tipo 2Outros IDs do estudo
- 18806
- J1I-MC-GZQA (Outro identificador) (Eli Lilly and Company)
Número NCT
Data de início (real)
2024-03-15
Última atualização postada
2025-12-24
Data de conclusão (estimada)
2026-11
Inscrição (estimada)
320
Tipo de estudo
Intervencionista
FASE
Fase III
Status
Ativo, não recrutando
Palavras-chave
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Disease
Renal Insufficiency Chronic
Metabolic Diseases
Endocrine System Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Disease
Renal Insufficiency Chronic
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Duplo-cego
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalRetatrutide Dose 1 Participants will receive retatrutide administered subcutaneously (SC). | Retatrutide Administered SC |
ExperimentalRetatrutide Dose 2 Participants will receive retatrutide administered SC. | Retatrutide Administered SC |
ExperimentalRetatrutide Dose 3 Participants will receive retatrutide administered SC. | Retatrutide Administered SC |
Comparador placeboPlacebo Participants will receive placebo administered SC. | PLACEBO Administered SC |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Change from Baseline in Hemoglobin A1c (HbA1c) (%) | Baseline, Week 52 |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 | Measured during the CGM session that occurs during 30 days prior to Week 52 | 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 |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
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
Eli LillySem dados de contato.
76 Locais do estudo em 7 países
Centro de Diabetes Curitiba, Curitiba, 80810-040, Brazil
Instituto de Ensino e Pesquisa Clinica do Ceara, Fortaleza, 60125058, Brazil
Centro de Pesquisas Clínicas Dr. Marco Mota, Maceió, 57051-160, Brazil
IBPClin - Instituto Brasil de Pesquisa Clínica, Rio de Janeiro, 20241-180, Brazil
Praxis Pesquisa Medica, Santo André, 09790790, Brazil
Instituto de Pesquisa Clinica, São Paulo, 01223-001, Brazil
CEDOES, Vitória, 29055450, Brazil
Alabama
Nephrology Consultants, Huntsville, Alabama, 35805, United States
Arizona
Clinical Research Institute of Arizona (CRI) - Sun City West, Sun City West, Arizona, 85375, United States
California
Kidney & Hypertension Center - Apple Valley, Apple Valley, California, 92307, United States
Hope Clinical Research, Inc., Canoga Park, California, 91303, United States
Neighborhood Healthcare Institute of Health, Escondido, California, 92025, United States
EndoTrials Center for Clinical Research, La Mesa, California, 91942, United States
UCLA South Bay Endocrinology, Torrance, California, 90505, United States
Florida
Northeast Research Institute (NERI), Fleming Island, Florida, 32003, United States
Encore Medical Research - Weston, Weston, Florida, 33331, United States
Georgia
Orita Clinical Research, Decatur, Georgia, 30034, United States
Idaho
CARE Institute, Idaho Falls, Idaho, 83404, United States
Kansas
Cotton O'Neil Diabetes & Endocrinology, Topeka, Kansas, 66606, United States
Montana
Billings Clinic, Billings, Montana, 59101, United States
Nevada
Excel Clinical Research, LLC, Las Vegas, Nevada, 89109, United States
New York
Albany Medical College, Division of Community Endocrinology, Albany, New York, 12203, United States
NYC Research INC, Long Island City, New York, 11106, United States
Research Foundation of SUNY - University of Buffalo, Williamsville, New York, 14221, United States
North Carolina
University of North Carolina Medical Center, Chapel Hill, North Carolina, 27514, United States
Oklahoma
Central States Research, Tulsa, Oklahoma, 74136, United States
Pennsylvania
Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair, Pittsburgh, Pennsylvania, 15243, United States
Tennessee
AM Diabetes & Endocrinology Center, Bartlett, Tennessee, 38133, United States
Texas
Velocity Clinical Research, Dallas, Dallas, Texas, 75230, United States
Prime Revival Research Institute, LLC, Flower Mound, Texas, 75098, United States
Juno Research, Houston, Texas, 77040, United States
PlanIt Research, PLLC, Houston, Texas, 77079, United States
Southern Endocrinology Associates, Mesquite, Texas, 75149, United States
Texas Valley Clinical Research, Weslaco, Texas, 78596, United States
Utah
Diabetes & Endocrine Treatment Specialists, Sandy City, Utah, 84093, United States
Investigaciones Medicas Imoba Srl, Buenos Aires, C1056ABH, Argentina
Centro de Investigaciones Metabólicas (CINME), Buenos Aires, C1056ABI, Argentina
CIPREC, Buenos Aires, C1061AAS, Argentina
CIPREC, Buenos Aires, C1119ACN, Argentina
Centro Médico Viamonte, Buenos Aires, C1120AAC, Argentina
Mautalen Salud e Investigación, Buenos Aires, C1128AAF, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada, Buenos Aires, C1425AGC, Argentina
CEDIC, CABA, C1060ABN, Argentina
Centro Diabetológico Dr. Waitman, Córdoba, 5000, Argentina
Centro Médico Colón, Córdoba, X5003DCP, Argentina
Centro de Investigaciones Clínicas Baigorria, Granadero Baigorria, 2152, Argentina
CIMeL, Lanús, B1824KAJ, Argentina
Centro de Investigaciones Médicas Mar del Plata, Mar del Plata, 7600, Argentina
DIM Clínica Privada, Ramos Mejía, B1704ETD, Argentina
INECO Neurociencias Oroño, Rosario, 2000, Argentina
Instituto Médico Catamarca IMEC, Rosario, 2000, Argentina
Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica, Rosario, 2000, Argentina
Instituto de Investigaciones Clinicas Rosario, Rosario, S2000CVD, Argentina
Clalit Health Services - Atlit, Atlit, 3032301, Israel
Soroka Medical Center, Beersheba, 8410101, Israel
Institute of Diabetes, Technology and Research - Clalit Health, Herzliya, 4630945, Israel
Edith Wolfson Medical Center, Holon, 5810001, Israel
Hadassah Medical Center, Jerusalem, 9112001, Israel
Sheba Medical Center, Ramat Gan, 5262100, Israel
Clalit Health Services - Sakhnin Community Clinic, Sakhnin, 3081000, Israel
Enclifar Ensayos Clínicos Farmacológicos Sc, Chihuahua City, 31110, Mexico
Diseno y Planeacion en Investigacion Medica, Guadalajara, 44130, Mexico
Medical Care and Research SA de CV, Mérida, 97070, Mexico
FAICIC S. de R.L. de C.V., Veracruz, 91900, Mexico
Centro de Endocrinologia Alcantara Gonzalez, Bayamón, 00956, Puerto Rico
Isis Clinical Research Center, Guaynabo, 00968, Puerto Rico
Mgcendo Llc, San Juan, 00921, Puerto Rico
Southmead Hospital, Bristol, BS10 5NB, United Kingdom
Edinburgh Royal Infirmary, Edinburgh, EH16 4SA, United Kingdom
Panthera Biopartners - Glasgow, Glasgow, G51 4LB, United Kingdom
George Eliot Hospital, Nuneaton, CV10 7DJ, United Kingdom
Panthera Biopartners - Preston, Preston, PR2 9QB, United Kingdom
Panthera Biopartners - Manchester, Rochdale, OL11 4AU, United Kingdom
Salford Royal Hospital, Salford, M6 8HD, United Kingdom
Lister Hospital, Stevenage, SG1 4AB, United Kingdom
The Royal Cornwall Hospital, Truro, TR1 3LJ, United Kingdom