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

NCT07734311 | Not Yet Recruiting Phase 3

• 1 other identifier: SCW0502-6031
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Knee Osteoarthritis; Obesity

Keywords

Ecnoglutide; KOA; Obesity

Outcome Measures

Primary Outcomes (2)

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

  Baseline, week 68

• Percentage Change in Body Weight

  Baseline, week 68

Secondary Outcomes (32)

• Percentage of Participants with ≥5% of Body Weight Loss

  Baseline, week 68

• Percentage of Participants with ≥10% of Body Weight Loss

  Baseline, week 68

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

  Baseline, week 68

• Change in WOMAC Physical Function Subscale Score

  Baseline, week 68

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

  Baseline, week 68

Study Arms (2)

Ecnoglutide Injection

EXPERIMENTAL

Once weekly

Drug: Ecnoglutide Injection

Placebo

PLACEBO COMPARATOR

Once weekly

Drug: placebo with matching volume

Interventions

Ecnoglutide Injection DRUG

subcutaneous injection

Ecnoglutide Injection

placebo with matching volume DRUG

subcutaneous injection

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hangzhou Sciwind Biosciences Co., Ltd.: lead

Study Sites (1)

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

Wuhan, Hubei, China

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Obesity

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Weihua XU

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yao Li

CONTACT

010-67889255; yao.li@sciwindbio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 29, 2026
• Study Start: July 31, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)