Efficacy and Safety of Ribupatide Administered Once Weekly in Participants Living With Obesity or Overweight and 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 and Diabetes

Обзор

The primary objective of this study is to demonstrate that ribupatide (KAI-9531) subcutaneous (SC) injection once weekly is superior to placebo on: * Percent change in body weight * Change in hemoglobin A1c (HbA1c)

Вмешательства

• Препарат Ribupatide
  SC Injection
• Препарат Placebo
  SC Injection

Первичные конечные точки

• Doses 3 and 4 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76 [Срок оценки: Baseline, Week 76]
• Doses 3 and 4 of Ribupatide Versus Placebo: Change From Baseline in HbA1c at Week 76 [Срок оценки: Baseline, Week 76]

Вторичные конечные точки (12)

• Doses 1 and 2 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76 [Срок оценки: Baseline, Week 76]
• Doses 1 and 2 of Ribupatide Versus Placebo: Change From Baseline in HbA1c 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]
• Percentage of Participants with HbA1c <7% and ≤6.5% [Срок оценки: Baseline, Week 76]
• Change From Baseline in Fasting Blood Glucose [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]

Критерии участия

Критерии включения

• Diagnosis of type 2 diabetes mellitus (T2DM).
• Receiving stable therapy for T2DM for 3 months prior to Screening. This includes diet and/or exercise alone or in combination with any oral medication for T2DM treatment except for DPP-4 inhibitors. Participants can be treatment naïve if they have an HbA1c of 6.5% to 7.5%, inclusive.
• BMI ≥27 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 type 1 diabetes mellitus (T1DM) or any other type of diabetes except T2DM.
• History of diabetic ketoacidosis or hyperosmolar state/coma within 1 year prior to Screening.
• History of severe hypoglycemia or hypoglycemia unawareness within 1 year prior to Screening.
• 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 (GI) motility if taken for >30 days continually within 3 months prior to Screening.
• History of suicide attempt.
• History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder within 2 years prior to Screening.
• Received treatment with semaglutide, tirzepatide, GLP-1 receptor agonists, GLP-1/glucose-dependent insulinotropic polypeptide (GIP) agonists, glucagon receptor agonists, or other weight loss medications or treatments aside from diet and exercise 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 · 41 центр

• Kailera Clinical Site — Cullman
• Kailera Clinical Site — Phoenix
• Kailera Clinical Site — Sun City
• Kailera Clinical Site — Little Rock
• Kailera Clinical Site — Escondido
• Kailera Clinical Site — Montclair
• Kailera Clinical Site — Northridge
• Kailera Clinical Site — Oceanside
• … и ещё 33 центра

Австралия · 12 центров

• Kailera Clinical Site — Bruce
• Kailera Clinical Site — Blacktown
• Kailera Clinical Site — Kanwal
• Kailera Clinical Site — Leichhardt
• Kailera Clinical Site — Sydney
• Kailera Clinical Site — Sydney
• Kailera Clinical Site — Wollongong
• Kailera Clinical Site — Herston
• … и ещё 4 центра

Польша · 11 центров

Список центров уточняется — проверьте первичный протокол.

Аргентина · 9 центров

• Kailera Clinical Site — Ciudad Autonoma de Buenos Aires
• Kailera Clinical Site — Mar del Plata
• Kailera Clinical Site — San Nicolás de los Arroyos
• Kailera Clinical Site — Zárate
• Kailera Clinical Site — Buenos Aires
• Kailera Clinical Site — Godoy Cruz
• Kailera Clinical Site — Rosario
• Kailera Clinical Site — CABA
• … и ещё 1 центр

Болгария · 9 центров

• Kailera Clinical Site — Kyustendil
• Kailera Clinical Site — Pleven
• Kailera Clinical Site — Plovdiv
• Kailera Clinical Site — Rousse
• Kailera Clinical Site — Sofia
• Kailera Clinical Site — Sofia
• Kailera Clinical Site — Stara Zagora
• Kailera Clinical Site — Varna
• … и ещё 1 центр

Чехия · 8 центров

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

Новая Зеландия · 8 центров

Список центров уточняется — проверьте первичный протокол.

Великобритания · 8 центров

Список центров уточняется — проверьте первичный протокол.

Германия · 5 центров

• Kailera Clinical Site — Falkensee
• … и ещё 4 центра

Испания · 4 центра

Список центров уточняется — проверьте первичный протокол.

Пуэрто-Рико · 1 центр

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07284901 · K9531-3104 · 2025-523510-87-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗