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RecruitingPhase 3

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)

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

NCT IDNCT07734311
Org study IDSCW0502-6031

Timeline

Milestones

Study first posted2026-07-29actual
Study start2026-08-03actual
Last update posted2026-08-31actual
Primary completion2028-05-31estimated
Study completion2028-06-30estimated

Assets

Investigational agents

Who this study enrolls

Obesity / overweightOsteoarthritis

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

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

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

Other (unclassified)
11
Weight & body composition
8
Glycemic / diabetes
5
Patient-reported / QoL
5
Cardiometabolic biomarkers
2
Safety / tolerability / PK
2
Heart failure
1

Weight & body composition

8 endpoints
Primary/protocol endpoint

Percentage Change in Body Weight

Time frame:Baseline, week 68

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants with ≥5% of Body Weight Loss

Time frame:Baseline, week 68

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants with ≥10% of Body Weight Loss

Time frame:Baseline, week 68

threshold achievement, improvement

Secondary/protocol endpoint

Absolute Change in Body Weight

Time frame:Baseline, week 68

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants with ≥15% of Body Weight Loss

Time frame:Baseline, week 68

threshold achievement, improvement

Secondary/protocol endpoint

Change in Body Mass Index (BMI)

Time frame:Baseline, week 68

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:Baseline, week 68

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist-to-hip Ratio

Time frame:Baseline, week 68

change from baseline, improvement

Glycemic / diabetes

5 endpoints
Secondary/protocol endpoint

Change in Fasting Plasma Glucose (FPG)

Time frame:Baseline, week 68

change from baseline, improvement

Secondary/protocol endpoint

Change in HbA1c

Time frame:Baseline, week 68

change from baseline, improvement

Secondary/protocol endpoint

Change in Fasting Insulin

Time frame:Baseline, week 68

change from baseline, improvement

Secondary/protocol endpoint

Change in Fasting C-peptide

Time frame:Baseline, week 68

change from baseline, improvement

Secondary/protocol endpoint

Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

Time frame:Baseline, week 68

change from baseline, improvement

Heart failure

1 endpoint
Secondary/protocol endpoint

Change in Walking Distance During the 6-minute Walk Test

Time frame:Baseline, week 68

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Change in Lipid Profile

Time frame:Baseline, week 68

change from baseline, improvement

Secondary/protocol endpoint

Change in Blood Pressure

Time frame:Baseline, week 68

change from baseline, improvement

Patient-reported / QoL

5 endpoints
Secondary/protocol endpoint

Change in Short Form 36 (SF36) V2 Physical Function Subscale Score

Time frame:Baseline, week 68

change from baseline, improvement

Secondary/protocol endpoint

Change in SF36V2 Score

Time frame:Baseline, week 68

change from baseline, improvement

Secondary/protocol endpoint

Change in PGI-S Pain and Function Score of the Target Knee Joint

Time frame:Baseline, week 68

change from baseline, improvement

Secondary/protocol endpoint

Change in PGI-C Pain and Function Score of the Target Knee Joint

Time frame:Baseline, week 68

change from baseline, improvement

Secondary/protocol endpoint

Change in Patient Health Questionnaire-9 (PHQ-9) Score

Time frame:Baseline to week 73 (EOS)

change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

Adverse events

Time frame:Week 1 to week 73 (EOS)

descriptive

Secondary/protocol endpoint

Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Score

Time frame:Baseline to week 73 (EOS)

change from baseline, event

Other (unclassified)

11 endpoints
Primary/protocol endpoint/low confidence

Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score

Time frame:Baseline, week 68

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Percentage of Participants with ≥50% of Reduction in WOMAC Pain Subscale Score

Time frame:Baseline, week 68

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in WOMAC Physical Function Subscale Score

Time frame:Baseline, week 68

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in WOMAC Total Score

Time frame:Baseline, week 68

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Percentage of Participants with ≥50% of Reduction in WOMAC Physical Function Subscale Score

Time frame:Baseline, week 68

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Percentage of Participants Using Allowed Analgesics During Wash Out

Time frame:Baseline, week 68

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Amount of Allowed Analgesics Used During Wash Out

Time frame:Baseline, week 68

descriptive

Secondary/protocol endpoint/low confidence

Percentage of Participants Using Analgesics

Time frame:Baseline, week 68

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Change in Amount of Analgesics Used

Time frame:Baseline, week 68

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Hip Circumference

Time frame:Baseline, week 68

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Trough Concentration of Ecnoglutide

Time frame:Week 1 to week 73 (EOS)

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.