A Study of Econoglutide Injection in Obese Participants With Knee Osteoarthritis (KOA)

Официальное название

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Ecnoglutide Injection in Obese Participants With Knee Osteoarthritis (KOA)

Обзор

The main purpose of the study is to evaluate the efficacy and safety of ecnoglutide injections versus placebo in obese participants with KOA.

Подробное описание

In this Phase III study, eligible participants will be randomized into one of the two cohorts in a 1:1 ratio to receive once-weekly subcutaneous ecnoglutide injection or placebo, including a dose-escalation period, with the total treatment duration of up to 68 weeks, plus 5 weeks of follow-up period. The overall study will last for 73 weeks.

Вмешательства

• Препарат Ecnoglutide Injection
  subcutaneous injection
• Препарат placebo with matching volume
  subcutaneous injection

Первичные конечные точки

• Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score [Срок оценки: Baseline, week 68]
• Percentage Change in Body Weight [Срок оценки: Baseline, week 68]

Вторичные конечные точки (12)

• Percentage of Participants with ≥5% of Body Weight Loss [Срок оценки: Baseline, week 68]
• Percentage of Participants with ≥10% of Body Weight Loss [Срок оценки: Baseline, week 68]
• Percentage of Participants with ≥50% of Reduction in WOMAC Pain Subscale Score [Срок оценки: Baseline, week 68]
• Change in WOMAC Physical Function Subscale Score [Срок оценки: Baseline, week 68]
• Change in Short Form 36 (SF36) V2 Physical Function Subscale Score [Срок оценки: Baseline, week 68]
• Absolute Change in Body Weight [Срок оценки: Baseline, week 68]
• Percentage of Participants with ≥15% of Body Weight Loss [Срок оценки: Baseline, week 68]
• Change in WOMAC Total Score [Срок оценки: Baseline, week 68]
• Percentage of Participants with ≥50% of Reduction in WOMAC Physical Function Subscale Score [Срок оценки: Baseline, week 68]
• Change in SF36V2 Score [Срок оценки: Baseline, week 68]
• Change in PGI-S Pain and Function Score of the Target Knee Joint [Срок оценки: Baseline, week 68]
• Change in PGI-C Pain and Function Score of the Target Knee Joint [Срок оценки: Baseline, week 68]

Критерии участия

Критерии включения

• Body mass index (BMI) ≥ 28.0 kg/m\^2;
• The target knee must meet the diagnostic criteria of American College of Rheumatology (ACR) for knee osteoarthritis (clinical and radiological), with moderate radiographic changes (Kellgren-Lawrence grade 2 or 3). The target knee is defined as the knee with the most symptomatic knee at screening period; if pain in both knees are equal, the target knee will be the most dominant leg (preferred leg);
• Prior to screening, target knee pain lasting more than 12 weeks, and according to participant's self-report or medical history at screening, target knee pain lasting more than 15 days in the past month;
• At screening and prior to randomization, WOMAC pain score (NRS 0-10) of the target knee must be between 4 and 9 (to avoid bias in reporting, participants must not be informed of the pain score used to determine eligibility for the study);
• Self-reported by the participant who has a history of unsuccessful weight loss attempt by diet and exercise.

Критерии исключения

• The target knee has undergone joint replacement surgery;
• The target knee has undergone arthroscopy within 12 months prior to screening;
• At the time of screening, the target knee joint has any clinical features and symptoms of other active infections or crystal-induced arthropathies, as well as any other active joint diseases that may interfere with assessment;
• The target knee has received intra-articular injections of hyaluronic acid, any other investigational drugs, or biologics within 3 months prior to screening; or has undergone any procedures that result in persistent sensory loss in the target knee (e.g., ablation) within 6 months prior to screening;
• Has received any intramuscular or oral corticosteroids (investigational or marketed) within 30 days prior to screening, or has received any intra-articular corticosteroid injections (investigational or marketed) in any joint within 90 days prior to screening;
• History of joint instability in either knee within 12 months prior to screening, such as anterior cruciate ligament rupture or recent trauma;
• History of any other potentially causative and/or confounding diseases, including Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, inflammatory bowel disease-associated arthritis, sarcoidosis, amyloidosis, or fibromyalgia;
• Presence of symptomatic hip osteoarthritis at the time of screening, with the exception of those who have undergone hip replacement surgery;
• Conditions that may interfere with the assessment of target knee pain during screening include, but are not limited to:

• Pain in any part of the lower limb or back equal to or more severe than the pain in the target knee;
• Pain radiating to the knee from other areas, such as hip pain affecting the knee or radicular pain;
• Chronic widespread pain (including neuropathic pain);
• Change of body weight >5% within 3 months prior to screening (selfreported);
• Diagnosis of diabetes (excluding gestational diabetes), or with a history of diabetic ketoacidosis or hyperosmolar state/coma

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

Китай · 1 центр

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Ухань

Идентификаторы

NCT: NCT07734311 · SCW0502-6031

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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