Estudio exploratorio de fase 2, de grupos paralelos, dobl... | EligiMed

Estudio exploratorio de fase 2, de grupos paralelos, doble ciego y controlado con placebo para investigar la reducción de peso con macupatida y eloralintida, solos o en combinación, en participantes adultos con obesidad o sobrepeso y diabetes tipo 2

ReclutandoFase 2ClinicalTrials.gov

ID: NCT07215559Tipo: INTERVENTIONALInicio: 16 de oct de 2025Fin estimado: 1 de may de 2027

Resumen

El propósito de este estudio es investigar la reducción de peso con macupatida y eloralintida, solos o en combinación, en participantes adultos con obesidad o sobrepeso y diabetes tipo 2. La participación en el estudio durará aproximadamente 48 semanas.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Have type 2 diabetes
Have an HbA1c ≥7.5% to ≤10.5% at screening
Have been treated with any of the following, alone or in combination, for at least 3 months prior to screening
Diet and exercise
Stable dose of metformin
Sodium-glucose cotransporter-2 (SGLT2) inhibitor
Have had a stable body weight (\<5% body weight gain and/or loss) for the 3 months prior to screening
Have a BMI of 27 or greater at screening

Criterios de exclusión

Have any form of diabetes other than type 2 diabetes
Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed \>1 year prior to screening
Have any of the following cardiovascular conditions within 3 months prior to screening:
acute myocardial infarction
cerebrovascular accident (stroke)
unstable angina, or
hospitalization due to congestive heart failure
Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years, exceptions include
basal or squamous cell skin cancer
in situ carcinomas of the cervix, or
in situ prostate cancer
Have been prescribed any of the following receptor agonists (RA) or their combination for any indication within the last 6 months:
amylin RA
dual amylin and calcitonin RA
glucagon-like peptide-1 receptor (GLP-1) RA
glucose-dependent insulinotropic peptide (GIP)/GLP-1 RA
GLP-1/glucagon (GCG) RAs, or
GIP/GLP-1/GCG RAs
Have used excluded antihyperglycemic medications within 3 months prior to screening (including, but not limited to, sulfonylureas, dipeptidyl peptidase-4 inhibitors, alpha-glucosidase inhibitors, thiazolidinediones, and meglitinides
Have used insulin for diabetic control within the prior year (short term use in certain situations allowed

Intervenciones

drug

Macupatide

Administered SC

drug

Eloralintide

Administered SC

drug

Macupatide Placebo

Administered SC

drug

Eloralintide Placebo

Administered SC

Ubicaciones

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, Argentina

RECRUITING

CENUDIAB

Buenos Aires, Argentina

RECRUITING

CEDIC

CABA, Argentina

RECRUITING

Instituto de Investigaciones Clínicas Córdoba

Córdoba, Argentina

RECRUITING

Clínica Universitaria Reina Fabiola

Córdoba, Argentina

RECRUITING

Go Centro Medico San Nicolás

San Nicolás, Argentina

RECRUITING

Patrocinadores

PrincipalEli Lilly and Company

Contactos

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

LillyTrials@Lilly.com 317-615-4559

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

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.