Estudio de fase 2, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y multicéntrico para evaluar la eficacia, seguridad y tolerabilidad de CT-388 administrado por vía subcutánea una vez por semana durante 48 semanas en participantes con sobrepeso u obesidad y diabetes mellitus tipo 2

Activo, no reclutaFase 2ClinicalTrials.gov

ID: NCT06628362Tipo: INTERVENTIONALInicio: 21 de nov de 2024Fin estimado: 30 de nov de 2026

Resumen

Este es un estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para determinar la dosis, diseñado para evaluar la eficacia y seguridad de CT-388 a dosis baja, media y alta en participantes con sobrepeso u obesidad y diabetes mellitus tipo 2 (DMT2).

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Male or female, 18 to 75 years of age
Body mass index (BMI) ≥25.0 kg/m\^2
Have a diagnosis of Type 2 Diabetes Mellitus (T2DM) according to the World Health Organization classification or other locally applicable standards
Have an HbA1c ≥7% and ≤10.5%
Management of T2DM with diet and exercise alone, metformin, or a sodium-glucose cotransporter-2 (SGLT-2) inhibitor, as monotherapy or in combination, per approved local label
At least one self-reported unsuccessful diet/exercise effort to lose body weight

Criterios de exclusión

Have Type 1 Diabetes Mellitus (T1DM), history of ketosis or hyperosmolar state/coma, or any other types of diabetes except T2DM
Have had 1 or more episodes of Level 3 hypoglycemia or have had hypoglycemia unawareness within 3 months prior to screening
Have history or presence of proliferative diabetic retinopathy, diabetic macular edema, or non-proliferative diabetic retinopathy that requires acute treatment
Have evidence of clinically significant autonomic neuropathy (symptoms may include resting tachycardia, orthostatic hypotension, or diabetic diarrhea)
Had treatment with any oral antihyperglycemic medications, with the exception of metformin or SGLT-2 inhibitors, within 3 months prior to screening or planned concurrent treatment with these medications during the study
Had treatment with injectable antihyperglycemic medication, with the exception of short-term insulin, within 6 months prior to screening or planned concurrent treatment with these medications during the study
Self-reported body weight change of \>5 kg within 3 months before screening
Any unbalanced/extreme diets, such as very low calorie, low carbohydrate, very high protein, ketogenic, or intermittent diets, within 3 months of the screening visit, or plan to be on such diets during the study
Current or recent use of any treatment that promotes weight loss or glucose metabolism
Current or recent use of treatment that may cause weight gain
Prior or planned surgical treatment or procedure for obesity, except for liposuction or abdominoplasty if performed \>1 year prior to screening. Participants with a history of devices, such as LAP-BAND® or intragastric balloon, are permitted, if devices were removed \>1 year prior to screening.
History of clinically significant or active gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction, intestinal obstruction), or chronic use of medications that directly affect GI motility
History of chronic pancreatitis or acute pancreatitis or have signs and symptoms of acute pancreatitis at screening
Have obesity induced by other endocrinologic disorders (e.g., Cushing syndrome) or diagnosed monogenetic or syndromic forms of obesity
History or diagnosis of significant active or unstable major depressive disorder or any history/diagnosis of other severe psychiatric conditions (e.g., schizophrenia; bipolar disorder; other serious mood disorder or anxiety disorder, or hyperactivity disorder) within the last year before screening
History of any hematologic conditions that may interfere with HbA1c measurement (e.g., hemolytic anemias, sickle cell disease, other hemoglobinopathies)
Family or personal history of medullary thyroid carcinoma
Women who are pregnant, breastfeeding, or intend to become pregnant, or are of childbearing potential and not using a highly effective contraceptive method as required per protocol

Intervenciones

drug

Placebo

Placebo will be volume-matched and administered subcutaneously (SC) once weekly.

drug

CT-388

CT-388 will be administered subcutaneously (SC) once weekly at the randomized dosing regimen.

Ubicaciones

Centro Medico Viamonte SRL

Buenos Aires, Provincia de Buenos, Argentina

Patrocinadores

PrincipalCarmot Therapeutics, Inc.

ColaboradorHoffmann-La Roche

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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