A Dose-Finding Study of Petrelintide With Enicepatide (RO7795068) in Adults With Obesity or Overweight

Официальное название

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy and Safety of Petrelintide Co-Administered With RO7795068 in Adults With Obesity or Overweight

Обзор

The main purpose of this study is to evaluate the safety and efficacy of the co-administration of petrelintide and enicepatide compared with placebo, petrelintide monotherapy, and enicepatide monotherapy in participants with obesity or overweight with at least one weight-related comorbidity.

Вмешательства

• Препарат Petrelintide
  Petrelintide will be administered subcutaneously to participants once weekly
• Комбинированный продукт Enicepatide
  Enicepatide will be administered subcutaneously to participants once weekly
• Препарат Petrelintide-matching Placebo
  Matching placebo to Petrelintide will be administered subcutaneously to participants once weekly
• Комбинированный продукт Enicepatide-matching Placebo
  Matching placebo to Enicepatide will be administered subcutaneously to participants once weekly

Первичные конечные точки

• Percentage Change in Body Weight between Arms 1 and 6 [Срок оценки: From Baseline to Week 40]

Вторичные конечные точки (12)

• Percentage Change in Body Weight between Arms 2, 3 and Arm 6 [Срок оценки: From Baseline to Week 40]
• Percentage Change in Body Weight between Arms 1, 2, 3 and Arms 4, 5 [Срок оценки: From Baseline to Week 40]
• Percentage of Participants Achieving Body Weight Loss [Срок оценки: From Baseline to Week 40]
• Change in Body Weight (kilograms [kg]) [Срок оценки: From Baseline to Week 40]
• Change in Body Mass Index (kilograms per square meter [kg/m²]) [Срок оценки: From Baseline to Week 40]
• Change in Waist Circumference (centimeter [cm]) [Срок оценки: From Baseline to Week 40]
• Change in Hemoglobin A1c (HbA1c) (percentage-points) [Срок оценки: From Baseline to Week 40]
• Change in Fasting Insulin [Срок оценки: From Baseline to Week 40]
• Change in Fasting Glucose [Срок оценки: From Baseline to Week 40]
• Change in Systolic Blood Pressure [Срок оценки: From Baseline to Week 40]
• Change in Diastolic Blood Pressure [Срок оценки: From Baseline to Week 40]
• Change in High-Density Lipoprotein (HDL) Cholesterol [Срок оценки: From Baseline to Week 40]

Критерии участия

Критерии включения

• Male or female participants with Body Mass Index (BMI) ≥ 30 kg/m² OR BMI ≥ 27 kg/m² to < 30 kg/m² with at least one weight-related comorbidity
• History of at least one self-reported unsuccessful dietary effort to lose body weight

Критерии исключения

• HbA1c ≥ 48 mmol/mol (6.5%) at screening
• History of Type 1 or Type 2 Diabetes
• Self-reported change in body weight > 5 kg within 90 days prior to screening
• Previous or planned obesity treatment with surgery (excluding liposuction, cryolipolysis, or abdominoplasty if performed > 1 year prior to or during screening)
• Previous or planned endoscopic and/or device-based obesity treatment or removal or device within the last 6 months prior to screening (e.g., mucosal ablation, gastric artery embolization, intragastric balloon and duodenal-jejunal endoluminal liner)
• Treatment with any GLP-1 receptor agonist, GLP-1/GIP receptor agonist (or any other GLP-1 based treatment) within 180 days prior to or during screening
• Current or previous treatment with petrelintide or any other amylin analog
• Obesity induced by Cushing syndrome or a diagnosis of monogenetic or syndromic forms of obesity
• History of severe psychiatric disorders
• History of any hematologic conditions that may interfere with HbA1c measurement
• Known history or presence of pancreatitis
• Known clinically significant gastric emptying abnormality or chronic treatment that affects GI motility
• New York Heart Association Functional Classification IV heart failure
• Pregnant or breastfeeding, or intending to become pregnant during the study or within the time frame in which contraception is required

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07589686 · CC46372

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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