A Study of Econoglutide Injection in Obese Participants With Knee Osteoarthritis (KOA)
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)
Lead sponsor
Asset
Ecnoglutide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
1
Estimated enrollment
360
Study population
Obesity / overweight, Osteoarthritis
Eligibility highlights
•BMI ≥28
Primary endpoints
•Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain•Body Weight
Registered trial locations
Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
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:
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
Endpoints (34)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
8 endpointsPercentage Change in Body Weight
Time frame:Baseline, week 68
percent change from baseline, improvement
Percentage of Participants with ≥5% of Body Weight Loss
Time frame:Baseline, week 68
threshold achievement, improvement
Percentage of Participants with ≥10% of Body Weight Loss
Time frame:Baseline, week 68
threshold achievement, improvement
Absolute Change in Body Weight
Time frame:Baseline, week 68
change from baseline, improvement
Percentage of Participants with ≥15% of Body Weight Loss
Time frame:Baseline, week 68
threshold achievement, improvement
Change in Body Mass Index (BMI)
Time frame:Baseline, week 68
change from baseline, improvement
Change in Waist Circumference
Time frame:Baseline, week 68
change from baseline, improvement
Change in Waist-to-hip Ratio
Time frame:Baseline, week 68
change from baseline, improvement
Glycemic / diabetes
5 endpointsChange in Fasting Plasma Glucose (FPG)
Time frame:Baseline, week 68
change from baseline, improvement
Change in HbA1c
Time frame:Baseline, week 68
change from baseline, improvement
Change in Fasting Insulin
Time frame:Baseline, week 68
change from baseline, improvement
Change in Fasting C-peptide
Time frame:Baseline, week 68
change from baseline, improvement
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Time frame:Baseline, week 68
change from baseline, improvement
Heart failure
1 endpointChange in Walking Distance During the 6-minute Walk Test
Time frame:Baseline, week 68
change from baseline, improvement
Cardiometabolic biomarkers
2 endpointsChange in Lipid Profile
Time frame:Baseline, week 68
change from baseline, improvement
Change in Blood Pressure
Time frame:Baseline, week 68
change from baseline, improvement
Patient-reported / QoL
5 endpointsChange in Short Form 36 (SF36) V2 Physical Function Subscale Score
Time frame:Baseline, week 68
change from baseline, improvement
Change in SF36V2 Score
Time frame:Baseline, week 68
change from baseline, improvement
Change in PGI-S Pain and Function Score of the Target Knee Joint
Time frame:Baseline, week 68
change from baseline, improvement
Change in PGI-C Pain and Function Score of the Target Knee Joint
Time frame:Baseline, week 68
change from baseline, improvement
Change in Patient Health Questionnaire-9 (PHQ-9) Score
Time frame:Baseline to week 73 (EOS)
change from baseline, improvement
Safety / tolerability / PK
2 endpointsAdverse events
Time frame:Week 1 to week 73 (EOS)
descriptive
Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Time frame:Baseline to week 73 (EOS)
change from baseline, event
Other (unclassified)
11 endpointsChange in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
Time frame:Baseline, week 68
change from baseline, improvement
Percentage of Participants with ≥50% of Reduction in WOMAC Pain Subscale Score
Time frame:Baseline, week 68
change from baseline, improvement
Change in WOMAC Physical Function Subscale Score
Time frame:Baseline, week 68
change from baseline, improvement
Change in WOMAC Total Score
Time frame:Baseline, week 68
change from baseline, improvement
Percentage of Participants with ≥50% of Reduction in WOMAC Physical Function Subscale Score
Time frame:Baseline, week 68
change from baseline, improvement
Percentage of Participants Using Allowed Analgesics During Wash Out
Time frame:Baseline, week 68
threshold achievement, improvement
Amount of Allowed Analgesics Used During Wash Out
Time frame:Baseline, week 68
descriptive
Percentage of Participants Using Analgesics
Time frame:Baseline, week 68
threshold achievement, improvement
Change in Amount of Analgesics Used
Time frame:Baseline, week 68
change from baseline, improvement
Change in Hip Circumference
Time frame:Baseline, week 68
change from baseline, improvement
Trough Concentration of Ecnoglutide
Time frame:Week 1 to week 73 (EOS)
concentration, descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.