A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Obesity or Overweight, and Type 2 Diabetes

ReclutandoFase 3ClinicalTrials.gov

ID: NCT07282600Tipo: INTERVENTIONALInicio: 15 de dic de 2025Fin estimado: 1 de feb de 2028

Traducción no disponible, mostrando original

Resumen

The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with placebo for body weight reduction in participants with overweight or obesity and type 2 diabetes. Participation in the study will last about 75 weeks.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Have type 2 diabetes
Are on stable treatment for type 2 diabetes for at least 90 days prior to screening
Have a BMI ≥ 27 kg/m2
Have a stable body weight (\<5% body weight change) for 90 days prior to screening

Criterios de exclusión

Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed \>1 year before screening)
Have a prior or planned endoscopic procedure and/or device-based therapy for obesity (prior device-based therapy acceptable if device removal was more than 6 months prior to screening)
Have type 1 diabetes
Have taken any of the following antihyperglycemic medications within 90 days before screening:
amylin analogs
glucagon-like peptide-1 (GLP-1) receptor agonists
glucose-dependent insulinotropic polypeptide/glucagon-like peptide-1 (GIP/GLP) receptor agonists, or
insulin
Have had within 90 days prior to screening:
heart attack
stroke
coronary artery revascularization
unstable angina, or
hospitalization due to congestive heart failure
Have a history or diagnosis of New York Heart Association Functional Classification Class IV congestive heart failure
Have taken medications or alternative remedies intended for weight loss within 90 days of screening

Intervenciones

drug

Eloralintide

Administered SC

drug

Placebo

Administered SC

Ubicaciones

Stat Research S.A.

Buenos Aires, Argentina

NOT_YET_RECRUITING

Investigaciones Medicas Imoba Srl

Buenos Aires, Argentina

NOT_YET_RECRUITING

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, Argentina

NOT_YET_RECRUITING

Mautalen Salud e Investigación

Buenos Aires, Argentina

NOT_YET_RECRUITING

Asociación de Beneficencia Hospital Sirio Libanés

Buenos Aires, Argentina

NOT_YET_RECRUITING

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Buenos Aires, Argentina

NOT_YET_RECRUITING

Instituto Centenario

CABA, Argentina

NOT_YET_RECRUITING

Centro Diabetológico Dr. Waitman

Córdoba, Argentina

NOT_YET_RECRUITING

Centro de Investigaciones Clínicas Baigorria

Granadero Baigorria, Argentina

NOT_YET_RECRUITING

Fundacion Estudios Clinicos

Rosario, Argentina

NOT_YET_RECRUITING

Instituto Médico Catamarca IMEC

Rosario, Argentina

NOT_YET_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.

A Phase 3 Randomized, Double-Blind, Placebo-Controlled St... | EligiMed