Efficacy and Safety of Ribupatide Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes

Официальное название

A Phase 3, Randomized, Active- and Placebo-Controlled, Partially-Blinded Study to Compare the Efficacy and Safety of KAI-9531 Administered Once Weekly Versus Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes

Обзор

The primary objective of this study is to demonstrate that ribupatide (KAI-9531) subcutaneous (SC) injection once weekly is superior to semaglutide SC once weekly and to placebo SC once weekly on percent change in body weight.

Вмешательства

• Препарат Ribupatide
  SC Injection
• Препарат Semaglutide
  SC Injection
• Препарат Placebo
  SC Injection

Первичные конечные точки

• Percent Change From Baseline in Body Weight at Week 76 [Срок оценки: Baseline, Week 76]

Вторичные конечные точки (12)

• Percentage of Participants with ≥10%, ≥15%, ≥20% and ≥25% Reduction in Body Weight [Срок оценки: Baseline, Week 76]
• Change From Baseline in Waist Circumference [Срок оценки: Baseline, Week 76]
• Change From Baseline in Absolute Body Weight [Срок оценки: Baseline, Week 76]
• Percentage of Participants with ≥5% Reduction in Body Weight [Срок оценки: Baseline, Week 76]
• Change From Baseline in Systolic Blood Pressure (SBP) [Срок оценки: Baseline, Week 76]
• Percent Change From Baseline in Fasting Triglycerides [Срок оценки: Baseline, Week 76]
• Percent Change From Baseline in Fasting High-density Lipoprotein (HDL)-cholesterol [Срок оценки: Baseline, Week 76]
• Percent Change From Baseline in Fasting Non-HDL-cholesterol [Срок оценки: Baseline, Week 76]
• Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score [Срок оценки: Baseline, Week 76]
• Percentage of Participants with ≥30% Reduction in Body Weight [Срок оценки: Baseline, Week 76]
• Change From Baseline in Body Mass Index (BMI) [Срок оценки: Baseline, Week 76]
• Change From Baseline in Control of Eating Questionnaire (CoEQ) Craving Control Score [Срок оценки: Baseline, Week 76]

Критерии участия

Критерии включения

• BMI ≥35 kilograms per square meter (kg/m\^2).
• History of being unresponsive to at least 1 self-reported effort to lose weight with diet and/or exercise in the last 6 months.

Критерии исключения

• Current diagnosis or history of diabetes mellitus.
• Started medications within 3 months prior to Screening that may cause significant weight change, including, but not limited to, tricyclic antidepressants, atypical antipsychotics, mood stabilizers, and phentermine.
• Unstable weight defined as self-reported change in body weight exceeding 5% within the 3 months prior to Screening.
• Family or personal history of multiple endocrine neoplasia Type 2 or medullary thyroid cancer.
• Uncontrolled hypertension or unstable cardiovascular disease.
• History of chronic or acute pancreatitis.
• Known clinically significant gastric-emptying abnormality or chronic treatment with medications that directly affect gastrointestinal motility.
• History of suicide attempt.
• History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder.
• Received treatment with semaglutide, tirzepatide, glucagon-like peptide-1 receptor (GLP-1R) agonist, GLP-1/glucose-dependent insulinotropic polypeptide (GIP), or glucagon receptor agonist within 3 months prior to Screening.

Note: Additional inclusion/exclusion criteria may apply, per protocol.

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 · 27 центров

• Kailera Clinical Site — Glendale
• Kailera Clinical Site — Phoenix
• Kailera Clinical Site — Little Rock
• Kailera Clinical Site — Northridge
• Kailera Clinical Site — Oceanside
• Kailera Clinical Site — Hamden
• Kailera Clinical Site — Stamford
• Kailera Clinical Site — Orange City
• … и ещё 19 центров

Польша · 8 центров

• Kailera Clinical Site — Krakow
• Kailera Clinical Site — Wroclaw
• Kailera Clinical Site — Warsaw
• Kailera Clinical Site — Gdynia
• Kailera Clinical Site — Chorzów
• Kailera Clinical Site — Gdynia
• Kailera Clinical Site — Wroclaw
• Kailera Clinical Site — Kielce

Австралия · 7 центров

• Kailera Clinical Site — Bruce
• Kailera Clinical Site — Blacktown
• Kailera Clinical Site — Kanwal
• Kailera Clinical Site — Herston
• Kailera Clinical Site — Morayfield
• Kailera Clinical Site — South Brisbane
• Kailera Clinical Site — Camberwell

Болгария · 7 центров

• Kailera Clinical Site — Pleven
• Kailera Clinical Site — Plovdiv
• Kailera Clinical Site — Sofia
• Kailera Clinical Site — Sofia
• Kailera Clinical Site — Montana
• Kailera Clinical Site — Sofia
• Kailera Clinical Site — Sofia

Великобритания · 4 центра

• Kailera Clinical Site — Exeter
• Kailera Clinical Site — London
• Kailera Clinical Site — Leicester
• Kailera Clinical Site — Rotherham

Идентификаторы

NCT: NCT07284979 · K9531-3107 · 2025-523511-11-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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