A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes

Официальное название

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 Administered to Participants With Obesity or Overweight Without Type 2 Diabetes

Обзор

The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with placebo for weight management in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity.

Вмешательства

• Комбинированный продукт Placebo
  Placebo will be volume-matched and administered once weekly using an integrated drug-device combination product.
• Комбинированный продукт Enicepatide
  Enicepatide will be administered once weekly at the randomized dosing regimen using an integrated drug-device combination product.

Первичные конечные точки

• Percent (%) Change from Baseline in Body Weight at Week 72 [Срок оценки: Baseline through Week 72]

Вторичные конечные точки (12)

• Percentage of Participants Achieving ≥5% Body Weight Loss from Baseline at Week 72 [Срок оценки: Baseline and Week 72]
• Percentage of Participants Achieving ≥10% Body Weight Loss from Baseline at Week 72 [Срок оценки: Baseline and Week 72]
• Percentage of Participants Achieving ≥15% Body Weight Loss from Baseline at Week 72 [Срок оценки: Baseline and Week 72]
• Percentage of Participants Achieving ≥20% Body Weight Loss from Baseline at Week 72 [Срок оценки: Baseline and Week 72]
• Percentage of Participants Achieving ≥25% Body Weight Loss from Baseline at Week 72 [Срок оценки: Baseline and Week 72]
• Change from Baseline in Body Weight (kg) at Week 72 [Срок оценки: Baseline through Week 72]
• Change from Baseline in Waist Circumference (cm) at Week 72 [Срок оценки: Baseline through Week 72]
• Change from Baseline in Fasting Glucose at Week 72 [Срок оценки: Baseline through Week 72]
• Change from Baseline in Fasting Insulin at Week 72 [Срок оценки: Baseline through Week 72]
• Change from Baseline in Low-Density Lipoprotein (LDL) Cholesterol at Week 72 [Срок оценки: Baseline through Week 72]
• Change from Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 72 [Срок оценки: Baseline through Week 72]
• Change from Baseline in Triglyceride at Week 72 [Срок оценки: Baseline through Week 72]

Критерии участия

Критерии включения

• Participants must have at screening:

• Body mass index (BMI) greater than or equal to (≥)30.0 kg/m\^2; or
• BMI ≥27.0 kg/m\^2 and <30.0 kg/m\^2 with at least one weight-related comorbidity, such as prediabetes, hypertension, dyslipidemia, diagnosis of obstructive sleep apnea, or weight-related cardiovascular disease
• History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight
• Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)

Критерии исключения

• History of Type 1 diabetes mellitus (T1DM) or T2DM, or history of ketoacidosis or hyperosmolar state/coma. Prior, but not current, diagnosis of gestational diabetes is allowed if no history of diabetes is recorded since.
• Self-reported change in body weight >5 kg within 3 months prior to screening
• Obesity induced by other endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin 4 receptor deficiency or Prader-Willi syndrome)
• Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed.
• Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)
• History of acute or chronic pancreatitis or clinically significant gallbladder disease. History of acute pancreatitis caused by gallstones or clinically significant gallbladder disease is allowed if the participant had a cholecystectomy to resolve the problem at least 3 months prior to screening.
• Poorly controlled hypertension at screening
• Any of the following cardiovascular conditions within 3 months prior to screening: Acute myocardial infarction; Cerebrovascular accident (stroke)/transient ischemic attack; Unstable angina; Hospitalization due to congestive heart failure.
• Have a history of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder, or other serious mood or anxiety disorder). Participants with MDD or generalized anxiety disorder whose disease state is considered stable within 1 year prior to screening and expected to remain stable throughout the course of the study, in the opinion of the investigator, are allowed provided that they are not receiving prohibited medication.
• Treatment with any approved or investigational GLP-1-RA-based therapy (e.g., GLP-1 receptor mono agonist, GLP-1/GIP receptor dual agonist, GLP-1/GIP/Gluc receptor triple agonist) within 6 months prior to randomization

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

Лечение

Центры проведения

США · 36 центров

• Pinnacle Research Group — Anniston
• Alabama Clinical Therapeutics — Birmingham
• University of Alabama at Birmingham — Birmingham
• Arizona Clinical Trials — Tucson
• Artemis Institute for Clinical Research, LLC — San Diego
• Yale University — New Haven
• Rophe Adult and Pediatric Medicine/SKYCRNG — Union City
• East-West Medical Research Institute — Honolulu
• … и ещё 28 центров

Китай · 14 центров

• Affiliated Hospital of Jiangsu University — Zhenjiang
• Yan'an University Xianyang Hospital — Xianyang
• Jinan Central Hospital — Цзинань
• Peking University People's Hospital — Пекин
• Beijing Pinggu Hospital — Пекин
• The First Hospital of Jilin University — Changchun
• The Second People's Hospital of Hefei — Хэфэй
• Huizhou Central People's Hospital — Huizhou
• … и ещё 6 центров

Польша · 10 центров

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Франция · 9 центров

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Германия · 9 центров

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Испания · 9 центров

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Канада · 8 центров

• C-health Partners Inc — Calgary
• Unity Healthcare Clinic — Surrey
• Aggarwal and Associates — Brampton
• Hamilton Medical Research Group — Hamilton
• Wharton Medical Clinic — Hamilton
• Bluewater Clinical Research Group — Sarnia
• Diex Recherche Trois-Rivieres — Trois-Rivières
• Alpha Recherche Clinique — Québec

Италия · 8 центров

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Тайвань · 8 центров

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Великобритания · 8 центров

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Аргентина · 7 центров

• CINME — Buenos Aires
• CEDIC Centro de Investigaciones Clinicas — Buenos Aires
• Centro Medico Viamonte SRL — Buenos Aires
• IME - Instituto Médico Especializado — Buenos Aires
• Instituto centenario — Ciudad Autonoma Buenos Aires
• Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada — Ciudad Autonoma Buenos Aires
• Centro de Investigaciones Medicas Mar Del Plata — Mar del Plata

Венгрия · 7 центров

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South Korea · 7 центров

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Чехия · 6 центров

• MUDr. Alena Váchová, Diabetologie — České Budějovice
• Edumed s.r.o.;Diabetologická ambulance — Náchod
• DIALINE s.r.o. — Plze?
• MediSpo Clinic — Prague
• DiaVize — Prague
• … и ещё 1 центр

Япония · 6 центров

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Бельгия · 5 центров

• AZORG Campus Aalst-Moorselbaan — Aalst
• Hospital Erasme — Brussels
• UZ Leuven Gasthuisberg — Leuven
• CHU de Liège (Sart Tilman) — Liège
• AZ Delta (Campus Rumbeke) — Roeselare

Австралия · 3 центра

• Paratus Clinical Western Sydney — Blacktown
• Southern Adelaide Diabetes and Endocrine Services (SADES) — Oaklands Park
• Baker Heart and Diabetes Insitute — Melbourne

Бразилия · 2 центра

• CPQuali Pesquisa Clinica Ltda — São Paulo
• Centro de Pesquisas Clinicas — São Paulo

Нидерланды · 2 центра

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Идентификаторы

NCT: NCT07351045 · WC45725 · 2025-523104-71-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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