Efficacy and Safety of Ribupatide in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes

Официальное название

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes

Обзор

The primary objective of the study is to determine the effects of ribupatide (KAI-9531) subcutaneous (SC) injection once weekly compared to placebo on percent change in body weight.

Вмешательства

• Препарат Ribupatide
  SC Injection
• Препарат Placebo
  SC Injection

Первичные конечные точки

• Dose 3 and 4 versus Placebo: Percent Change From Baseline in Body Weight at Week 76 [Срок оценки: Baseline, Week 76]

Вторичные конечные точки (12)

• Dose 1 and 2 versus Placebo: Percent Change From Baseline in Body Weight at Week 76 [Срок оценки: Baseline, Week 76]
• Percentage of Participants with ≥5%, ≥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]
• 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]
• Participants with Body Mass Index (BMI) ≥35 Kilograms per Square Meter (kg/m^2): Percent Change From Baseline in Body Weight [Срок оценки: Baseline, Week 76]
• Percentage of Participants with ≥30% Reduction in Body Weight [Срок оценки: Baseline, Week 76]
• Change From Baseline in BMI [Срок оценки: Baseline, Week 76]

Критерии участия

Критерии включения

• BMI ≥30 kg/m\^2 or BMI ≥27 kg/m\^2 and previously diagnosed with at least 1 of the following:

• hypertension,
• dyslipidemia,
• obstructive sleep apnea, or
• cardiovascular (CV) disease.
• 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, or phentermine.
• Unstable weight defined as self-reported change in body weight exceeding 5% within 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, GLP-1 receptor 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 · 24 центра

• Kailera Clinical Site — Anniston
• Kailera Clinical Site — Birmingham
• Kailera Clinical Site — Cullman
• Kailera Clinical Site — Sun City
• Kailera Clinical Site — Escondido
• Kailera Clinical Site — Toluca Lake
• Kailera Clinical Site — Aurora
• Kailera Clinical Site — Bridgeport
• … и ещё 16 центров

Австралия · 10 центров

• Kailera Clinical Site — Silverdale
• Kailera Clinical Site — Charlestown
• Kailera Clinical Site — Sydney
• Kailera Clinical Site — Sydney
• Kailera Clinical Site — Sydney
• Kailera Clinical Site — Wollongong
• Kailera Clinical Site — Sippy Downs
• Kailera Clinical Site — Norwood
• … и ещё 2 центра

Германия · 9 центров

• Kailera Clinical Site — Falkensee
• Kailera Clinical Site — Cologne
• Kailera Clinical Site — Essen
• Kailera Clinical Site — Dresden
• Kailera Clinical Site — Leipzig
• Kailera Clinical Site — Oldenburg in Holstein
• Kailera Clinical Site — Hamburg
• Kailera Clinical Site — Hamburg
• … и ещё 1 центр

Аргентина · 8 центров

• Kailera Clinical Site — San Nicolás de los Arroyos
• Kailera Clinical Site — Buenos Aires
• Kailera Clinical Site — Buenos Aires
• Kailera Clinical Site — Buenos Aires
• Kailera Clinical Site — Godoy Cruz
• Kailera Clinical Site — Rosario
• Kailera Clinical Site — CABA
• Kailera Clinical Site — Córdoba

Болгария · 8 центров

• Kailera Clinical Site — Kyustendil
• Kailera Clinical Site — Pazardzhik
• Kailera Clinical Site — Plovdiv
• Kailera Clinical Site — Plovdiv
• Kailera Clinical Site — Sofia
• Kailera Clinical Site — Sofia
• Kailera Clinical Site — Varna
• Kailera Clinical Site — Yambol

Великобритания · 8 центров

Список центров уточняется — проверьте первичный протокол.

Польша · 6 центров

• Kailera Clinical Site — Torun
• Kailera Clinical Site — Krakow
• Kailera Clinical Site — Siedlce
• Kailera Clinical Site — Warsaw
• Kailera Clinical Site — Skierniewice
• Kailera Clinical Site — Zamość

Испания · 6 центров

• Kailera Clinical Site — Ferrol
• Kailera Clinical Site — Villamartín
• Kailera Clinical Site — Castilleja de la Cuesta
• Kailera Clinical Site — Barcelona
• Kailera Clinical Site — Madrid
• Kailera Clinical Site — Valencia

Чехия · 5 центров

• Kailera Clinical Site — Brandýs nad Labem
• Kailera Clinical Site — Náchod
• Kailera Clinical Site — Brno
• Kailera Clinical Site — Hodonín
• Kailera Clinical Site — Uherské Hradiště

Новая Зеландия · 4 центра

• Kailera Clinical Site — Grafton
• Kailera Clinical Site — Hamilton
• Kailera Clinical Site — Auckland
• Kailera Clinical Site — Nelson

Идентификаторы

NCT: NCT07284875 · K9531-3103 · 2025-523486-17-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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