A Phase 2b Double-Blind, Randomized, Placebo-Controlled Study of Bimagrumab and Tirzepatide, Alone or in Combination, to Investigate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Type 2 Diabetes

RetiradoFase 2ClinicalTrials.gov

ID: NCT06901349Tipo: INTERVENTIONALInicio: 23 de may de 2025Fin estimado: 10 de jun de 2025

Traducción no disponible, mostrando original

Resumen

The main purpose of this study is to see how well and how safely bimagrumab, tirzepatide, and the combination, work in lowering body weight in participants with obesity or overweight and type 2 diabetes. Participation in the study will last about 13 months.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Have type 2 diabetes
Have a BMI of ≥27 kilograms per square meter (kg/m2)
Have had a stable body weight for the 3 months prior to randomization (\<5% body weight gain and/or loss)

Criterios de exclusión

Have a prior or planned surgical treatment for obesity,
Have type 1 diabetes, latent autoimmune diabetes, or history of ketoacidosis or hyperosmolar state or coma
Have poorly controlled hypertension
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 New York Heart Association (NYHA) Functional Classification III or IV congestive heart failure
Have ongoing or a history of frequent intermittent or chronic tachyarrhythmia syndromes
Have ongoing or a history of bradyarrhythmias other than sinus bradycardia
Have renal impairment
Have a history of symptomatic gallbladder disease within the past 2 years
Have signs and symptoms of any liver disease
Have a disease or condition known to cause gastrointestinal malabsorption or a known clinically significant gastric emptying abnormality
Have a history of acute or chronic pancreatitis
Currently taking or have taken medications that may cause significant weight gain or promote weight loss within 3 months prior to screening

Intervenciones

drug

Bimagrumab

Administered SC

drug

Tirzepatide

Administered SC

drug

Bimagrumab Placebo

Administered SC

drug

Tirzepatide Placebo

Administered SC

Ubicaciones

CIPREC

Buenos Aires, Buenos Aires F.D., Argentina

Centro Médico Viamonte

Buenos Aires, Buenos Aires F.D., Argentina

Consultorio de Investigación Clínica EMO SRL

Buenos Aires, Buenos Aires F.D., Argentina

CIPREC

Buenos Aires, Argentina

Patrocinadores

PrincipalEli Lilly and Company

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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