Clinical Trials in China / NCT07734311
Recruiting
Phase 3
A Study of Econoglutide Injection in Obese Participants With Knee Osteoarthritis (KOA)
NCT07734311 · tracked via the Priya Life Science China tracker
Condition(s) studied
Knee OsteoarthritisObesity
Investigational drug(s) / intervention(s)
Ecnoglutide Injection →placebo with matching volume
Ecnoglutide Injection: subcutaneous injection
placebo with matching volume: subcutaneous injection
Study summary
The main purpose of the study is to evaluate the efficacy and safety of ecnoglutide injections versus placebo in obese participants with KOA.
Eligibility
Inclusion Criteria:
1. Body mass index (BMI) ≥ 28.0 kg/m\^2;
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);
3. 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;
4. 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);
5. Self-reported by the participant who has a history of unsuccessful weight loss attempt by diet and exercise.
Exclusion Criteria:
1. The target knee has undergone joint replacement surgery;
2. The target knee has undergone arthroscopy within 12 months prior to screening;
3. 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;
4. 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;
5. 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;
6. History of joint instability in either knee within 12 months prior to screening, such as anterior cruciate ligament rupture or recent trauma;
7. 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;
8. Presence of symptomatic hip osteoarthritis at the time of screening, with the exception of those who have undergone hip replacement surgery;
9. 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);
10. Change of body weight \>5% within 3 months prior to screening (selfreported);
11. Diagnosis of diabetes (excluding gestational diabetes), or with a history of diabetic ketoacidosis or hyperosmolar state/coma
Primary outcome measure(s)
- Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score — Baseline, week 68
- Percentage Change in Body Weight — Baseline, week 68
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07734311 on ClinicalTrials.gov ↗ ← All trials in China