A Master Protocol to Investigate the Efficacy and Safety of LY3437943 Once Weekly in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight: A Randomized Double-Blind, Placebo-Controlled Trial

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT05929079Tipo: INTERVENTIONALInicio: 11 de jul de 2023Fin estimado: 1 de may de 2026

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to is to evaluate the efficacy and safety of retatrutide in participants with type 2 diabetes in participants who have obesity or overweight (J1I-MC-GZBK master protocol) including a subset of participants who have obstructive sleep apnea (OSA) (J1I-MC-GSA2). The study will last about 89 weeks and will include up to 24 visits.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Have a body mass index (BMI) greater than or equal to 27.0 kilogram/square meter (kg/m ²)
Have Type 2 Diabetes (T2D)
Are on stable treatment for T2D for at least 90 days
Have a history of at least one unsuccessful dietary effort to lose body weight.
Previously diagnosed with OSA
Have AHI ≥15 on polysomnography at screening (definition of moderate-to-severe OSA)
For participants not on positive airway pressure (PAP) therapy: unable or unwilling to use PAP therapy and have not used PAP for at least 4 weeks prior to screening.
If on PAP therapy, have been on PAP therapy for at least 3 consecutive months prior to screening, and willing to temporarily stop using PAP therapy for approximately 7 days prior to each of the sleep study (PSG) visits.

Criterios de exclusión

Have a self-reported or documented change in body weight \>5 kg (11 pounds) within 90 days.
Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
Have a prior or planned surgical treatment for obesity.
Have Type 1 diabetes
Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
Have had pancreatitis
Use stimulants (for example, modafinil, armodafinil, solriamfetol, pitolisant, amphetamine) less than 3 months prior to screening.
Use hypnotics, mirtazapine, opioids, trazodone, and zonisamide less than 3 months prior to screening.
Use a dental appliance or other device to treat OSA other than PAP therapy.

Intervenciones

drug

Retatrutide

Administered SC

drug

Placebo

Administered SC

Ubicaciones

Consultorio de Investigación Clínica EMO SRL

Buenos Aires, Buenos Aires F.D., Argentina

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 Salud e Investigaciones Médicas

Santa Rosa, La Pampa Province, Argentina

Patrocinadores

PrincipalEli Lilly and Company

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