A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes

Официальное название

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 in Adult Chinese Patients With Obesity or Overweight, With or Without Type 2 Diabetes Mellitus

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) being developed for chronic weight management, as an adjunct to a reduced-calorie diet and increased physical activity in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity, and in participants with T2DM who have obesity or overweight.

Вмешательства

• Комбинированный продукт Enicepatide
  Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
• Комбинированный продукт Placebo
  Participants will receive matching placebo via SC injection as per the schedule in the protocol.

Первичные конечные точки

• Percent Change From Baseline in Body Weight at Week 52 [Срок оценки: Baseline through Week 52]

Вторичные конечные точки (12)

• Percentage of Participants Achieving ≥5% Body Weight Loss at Week 52 [Срок оценки: At Week 52]
• Percentage of Participants Achieving ≥10% Body Weight Loss at Week 52 [Срок оценки: At Week 52]
• Percentage of Participants Achieving ≥15% Body Weight Loss at Week 52 [Срок оценки: At Week 52]
• Percentage of Participants Achieving ≥20% Body Weight Loss, in Participants Receiving Enicepatide Dose 2 and Dose 3 [Срок оценки: At Week 52]
• Change From Baseline in Body Weight at Week 52 [Срок оценки: Baseline through Week 52]
• Change From Baseline in Waist Circumference at Week 52 [Срок оценки: Baseline through Week 52]
• Change From Baseline in Fasting Glucose at Week 52 [Срок оценки: Baseline through Week 52]
• Change From Baseline in Fasting Insulin at Week 52 [Срок оценки: Baseline through Week 52]
• Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol at Week 52 [Срок оценки: Baseline through Week 52]
• Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 52 [Срок оценки: Baseline through Week 52]
• Change From Baseline in Triglyceride at Week 52 [Срок оценки: Baseline through Week 52]
• Change From Baseline in Systolic Blood Pressure at Week 52 [Срок оценки: Baseline through Week 52]

Критерии участия

Критерии включения

• Body mass index (BMI) ≥24.0 kilograms per meter squared (kg/m\^2) for participants with type 2 diabetes mellitus (T2DM)
• BMI ≥28.0 kg/m\^2 or BMI ≥24.0 and <28.0 kg/m\^2 and diagnosed with at least one weight-related comorbidity (prediabetes, hypertension, dyslipidemia, fatty liver, obstructive sleep apnea, or weight-related cardiovascular disease) for participants without T2DM
• Agreement to adhere to the contraception requirements

Критерии исключения

• History of Type 1 diabetes mellitus (T1DM)
• Obesity induced by other endocrinologic disorders
• Any planned major medical procedure or surgery during the study
• History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder
• Any lifetime history of suicide attempt
• History of any hematologic conditions that may interfere with HbA1c measurement
• History of acute or chronic pancreatitis or clinically significant gallbladder disease
• Treatment with any approved or investigational GLP-1-RA-based therapy within 6 months prior to randomization
• Treatment with other investigational therapy within 3 months prior to randomization or less than 5 elimination half-lives prior to randomization, whichever is longer
• Known allergy to any component of the study drug formulation or any other condition that is a contraindication to GLP-1 RAs or GLP-1/GIP RAs

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

Китай · 12 центров

• Yan'an University Xianyang Hospital — Xianyang
• The First Affiliated Hospital of Ningbo University(Ningbo First Hospital) — Ningbo
• Peking University People's Hospital — Пекин
• Jinan Central Hospital — Цзинань
• Hebei Petro China Central Hospital — Langfang
• Luoyang Third People's Hospital — Luoyang
• Shanghai Tenth People's Hospital — Шанхай
• Shanghai East Hospital — Шанхай
• … и ещё 4 центра

Идентификаторы

NCT: NCT07670416 · YC46401

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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