A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight

Официальное название

A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Interventions for Chronic Weight Management in Adult Participants With Obesity or Overweight

Обзор

The purpose of this Phase-2 chronic weight management master protocol (CWMM) is to create a framework to evaluate the safety and efficacy of various investigational interventions for chronic weight management with intervention-specific appendices (ISAs). The CWMM establishes entry criteria for newly enrolled participants across the master and the ISAs. The ISAs may start independently of other ISAs as interventions become available for clinical testing. The results for the CWMM screening record will be reported when all the ISA's complete.

Вмешательства

• Препарат LY3305677
  Administered SC. ISA specific interventions will be listed in the ISA.
• Препарат LY3841136
  Administered SC. ISA specific interventions will be listed in the ISA.
• Препарат Tirzepatide
  Administered SC. ISA specific interventions will be listed in the ISA.
• Препарат LY3549492
  Administered orally. ISA specific interventions will be listed in the ISA.
• Препарат LY3532226
  Administered SC. ISA specific interventions will be listed in the ISA.
• Препарат Placebo
  Administered SC. ISA specific interventions will be listed in the ISA.
• Препарат Placebo
  Administered orally. ISA specific interventions will be listed in the ISA.

Первичные конечные точки

• Number of Participants Allocated to Each ISA [Срок оценки: Baseline to Week 6]

Критерии участия

Критерии включения

• Have a body mass index (BMI)

• ≥30 kilogram/square meter (kg/m²), or
• ≥27 kg/m² and <30 kg/m², or with at least 1 weight-related comorbidity
• Have had a stable body weight for the 3 months prior to randomization (<5%) body weight gain and/or loss.

Критерии исключения

• 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 signs and symptoms of any liver disease other than nonalcoholic fatty liver disease.
• 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 symptomatic gallbladder disease within the past 2 years.
• Have a lifetime history of suicide attempts.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Скрининг

Центры проведения

США · 50 центров

• The Institute for Liver Health II dba Arizona Clinical Trials - Mesa — Chandler
• HOPE Research Institute — Phoenix
• Headlands Research - Scottsdale — Scottsdale
• The Institute for Liver Health II dba Arizona Liver Health-Tucson — Tucson
• NorCal Medical Research, Inc — Greenbrae
• Velocity Clinical Research, Huntington Park — Huntington Park
• Peninsula Research Associates — Rolling Hills Estates
• Diablo Clinical Research, Inc. — Walnut Creek
• … и ещё 42 центра

Аргентина · 4 центра

• Cicemo Srl — Buenos Aires
• Centro de Investigaciones Metabólicas (CINME) — Buenos Aires
• Centro Médico Viamonte — Buenos Aires
• Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada — Buenos Aires

Идентификаторы

NCT: NCT06143956 · 18685 · W8M-MC-CWMM · W8M-MC-OXA1 · W8M-MC-LAA1 · W8M-MC-LAA2 · W8M-MC-GN01 · W8M-MC-GN02 · W8M-MC-MC01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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