A Phase 2, Parallel-Group, Double-Blind Study to Investigate Weight Management With LY3841136 Compared With Placebo in Adult Participants With Obesity or Overweight

CompletadoFase 2ClinicalTrials.gov

ID: NCT06230523Tipo: INTERVENTIONALInicio: 5 de feb de 2024Fin estimado: 14 de ago de 2025

Traducción no disponible, mostrando original

Resumen

The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to investigate weight management efficacy and safety with LY3841136 compared with placebo in adult participants with obesity or overweight. The study will last about 64 weeks and may include up to 17 visits.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

W8M-MC-LAA1
Are males and females who agree to abide by the reproductive and contraceptive requirements
W8M-MC-CWMM:
Have a BMI ≥27 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

W8M-MC-LAA1
Have any prior diagnosis of diabetes mellitus except gestational diabetes.
Have any of the following cardiovascular conditions within 6 months prior to screening:
acute myocardial infarction
cerebrovascular accident (stroke)
unstable angina, or
hospitalization due to congestive heart failure (CHF).
Have a history of acute or chronic pancreatitis.
Have an on-going or history of bradyarrhythmia and/or sinus bradycardia at screening and baseline.
W8M-MC-CWMM
Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed \>1 year prior to screening.
Have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of ketoacidosis or hyperosmolar coma.
Have poorly controlled hypertension.
Have a history of symptomatic gallbladder disease within the past 2 years
Have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease.
Have a lifetime history of suicide attempts.

Intervenciones

drug

LY3841136

Administered SC.

drug

Placebo

Administered SC.

Ubicaciones

Centro Médico Viamonte

Buenos Aires, Buenos Aires F.D., Argentina

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Buenos Aires, Buenos Aires F.D., Argentina

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, Argentina

Patrocinadores

PrincipalEli Lilly and Company

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