A Trial of Ribupatide Injection in Participants With Obesity and Knee Osteoarthritis

Официальное название

A Multicenter, Randomized, Double-blind, Placebo-parallel-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Ribupatide Injection in Participants With Obesity and Knee Osteoarthritis

Обзор

The study is being conducted to evaluate the efficacy and safety of Ribupatide Injection in participants with obesity and knee osteoarthritis, and to explore its improvement on knee joint structure.

Вмешательства

• Препарат Ribupatide Injection
  Ribupatide Injection
• Препарат Placebo
  Placebo

Первичные конечные точки

• Change from baseline in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain score after 68 weeks of treatment [Срок оценки: after 68 weeks of continuous treatment, assessed every few weeks]
• Percentage change from baseline in body weight after 68 weeks of treatment [Срок оценки: after 68 weeks of continuous treatment, assessed every few weeks]

Вторичные конечные точки (9)

• After 68 weeks of treatment, changes from baseline in WOMAC joint function score; [Срок оценки: from first dose to 68 weeks after treatment]
• After 68 weeks of treatment, changes from baseline in WOMAC stiffness score; [Срок оценки: from first dose to 68 weeks after treatment]
• After 68 weeks of treatment, changes from baseline in Average Pain Intensity Numerical Rating Scale (API-NRS); [Срок оценки: from first dose to 68 weeks after treatment]
• After 68 weeks of treatment, changes from baseline in Worst Pain Intensity Numerical Rating Scale (WPI-NRS); [Срок оценки: from first dose to 68 weeks after treatment]
• Use of analgesics during the treatment period; [Срок оценки: from first dose up to week 72]
• After 68 weeks of treatment, changes from baseline in body weight [Срок оценки: from first dose to 68 weeks after treatment]
• After 68 weeks of treatment, changes from baseline in body mass index (BMI) [Срок оценки: from first dose to 68 weeks after treatment]
• After 68 weeks of treatment, changes from baseline in waist circumference [Срок оценки: from first dose to 68 weeks after treatment]
• Adverse events (AE). [Срок оценки: from first dose up to week 76]

Критерии участия

Критерии включения

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1、Voluntarily sign the informed consent form, agree to comply with the protocol requirements, and be willing and able to complete the study;

• 2、Aged ≥18 years on the date of signing the informed consent form, male or female;
• 3、BMI ≥28.0 kg/m² at screening;
• 4、Self-reported dietary and exercise control for 3 months or more prior to screening, and body weight change (difference between maximum and minimum body weight within 3 months) ≤5.0 kg in the 3 months prior to screening;
• 5、Based on the American College of Rheumatology criteria, the clinical diagnosis is knee osteoarthritis, and the target knee joint X-ray examination shows a K-L grade of 2-3 at screening.

Критерии исключения

• Existence of endocrine diseases that may significantly affect body weight;
• Existence of any conditions affecting gastric emptying;
• Known history of acute or chronic pancreatitis, pancreatic injury, acute cholecystitis, or symptomatic/treated gallbladder diseases;
• Known history or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2);
• Severe infection, major trauma, or major/medium surgery within 1 month prior to screening;
• History of severe cardiovascular or cerebrovascular diseases within 6 months prior to screening;
• History of malignancy in any organ system within 5 years prior to screening;
• Existence or suspicion of depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illnesses;
• Known or suspected history of alcohol and/or drug abuse or addiction;
• Symptoms or signs of acute or chronic hepatitis, or any liver disease other than metabolic dysfunction-associated fatty liver disease;
• Existence of serious hematologic diseases or any conditions causing hemolysis or red blood cell instability;
• Existence of autoimmune diseases requiring systemic glucocorticoid or immunosuppressive therapy during the study period;
• Known or suspected allergy to GLP-1 and/or GIP receptor agonists or their excipients;
• Participation in any drug or medical device clinical trial within 3 months prior to screening;
• Blood donation or cumulative blood loss ≥400 mL within 3 months prior to screening, or receipt of blood transfusion within 3 months;
• Participants with mental incompetence or language impairments that prevent full understanding or participation in the trial process.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Sixth People's Hospital — Шанхай

Идентификаторы

NCT: NCT07709910 · HRS9531-311

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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