Knee OsteoarthritisPhase 3NCT07734311
A Study of Econoglutide Injection in Obese Participants With Knee Osteoarthritis (KOA)
A Phase 3 study testing Ecnoglutide Injection in people with Knee Osteoarthritis and Obesity, run by Hangzhou Sciwind Biosciences Co., Ltd. at 1 site in China.
Trial summary
The main purpose of the study is to evaluate the efficacy and safety of ecnoglutide injections versus placebo in obese participants with KOA. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Knee Osteoarthritis, Obesity
- What is being tested?
- Ecnoglutide Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 3 Aug 2026to 30 Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Weihua XU, Dr, xuweihua@hust.edu.cn
About this study
Official title: 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)
The main purpose of the study is to evaluate the efficacy and safety of ecnoglutide injections versus placebo in obese participants with KOA.
Read the detailed description
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.
- Conditions
- Knee Osteoarthritis, Obesity
- Being tested
- Ecnoglutide Injection, placebo with matching volume
- Keywords
- Ecnoglutide, KOA, Obesity
- Medical subject headings
- Osteoarthritis, Knee, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecnoglutide InjectionDrug
subcutaneous injection
placebo with matching volumeDrug
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Ecnoglutide Injection | Experimental | Once weekly Receives: Drug: Ecnoglutide Injection |
| Placebo | Placebo comparator | Once weekly Receives: Drug: placebo with matching volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
Measured: Baseline, week 68
Percentage Change in Body Weight
Measured: Baseline, week 68
Secondary outcomes (32)
Percentage of Participants with ≥5% of Body Weight Loss
Measured: Baseline, week 68
Percentage of Participants with ≥10% of Body Weight Loss
Measured: Baseline, week 68
Percentage of Participants with ≥50% of Reduction in WOMAC Pain Subscale Score
Measured: Baseline, week 68
Change in WOMAC Physical Function Subscale Score
Measured: Baseline, week 68
Change in Short Form 36 (SF36) V2 Physical Function Subscale Score
Measured: Baseline, week 68
Absolute Change in Body Weight
Measured: Baseline, week 68
Percentage of Participants with ≥15% of Body Weight Loss
Measured: Baseline, week 68
Change in WOMAC Total Score
Measured: Baseline, week 68
Percentage of Participants with ≥50% of Reduction in WOMAC Physical Function Subscale Score
Measured: Baseline, week 68
Change in SF36V2 Score
Measured: Baseline, week 68
Change in PGI-S Pain and Function Score of the Target Knee Joint
PGI-S stands for Patient Global Impressions Scale - Severity
Measured: Baseline, week 68
Change in PGI-C Pain and Function Score of the Target Knee Joint
PGI-C stands for Patient Global Impressions Scale - Change
Measured: Baseline, week 68
Change in Body Mass Index (BMI)
Measured: Baseline, week 68
Change in Walking Distance During the 6-minute Walk Test
Measured: Baseline, week 68
Percentage of Participants Using Allowed Analgesics During Wash Out
Measured: Baseline, week 68
Amount of Allowed Analgesics Used During Wash Out
Amount of allowed analgesics used during wash out at end of treatment (week 68)is presented. Allowed analgesic during washout should be taken within 72 hour before the visit and prior to WOMAC assessment.
Measured: Baseline, week 68
Percentage of Participants Using Analgesics
Measured: Baseline, week 68
Change in Amount of Analgesics Used
Measured: Baseline, week 68
Change in Lipid Profile
Include triglicerides, LDL-C, HDL-C, total cholesterol
Measured: Baseline, week 68
Change in Fasting Plasma Glucose (FPG)
Measured: Baseline, week 68
Change in HbA1c
Measured: Baseline, week 68
Change in Fasting Insulin
Measured: Baseline, week 68
Change in Fasting C-peptide
Measured: Baseline, week 68
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Measured: Baseline, week 68
Change in Blood Pressure
Measured: Baseline, week 68
Adverse events
Measured: Week 1 to week 73 (EOS)
Change in Patient Health Questionnaire-9 (PHQ-9) Score
PHQ-9 questionnaire will be used to monitor status of mental health of the participants.
Measured: Baseline to week 73 (EOS)
Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Score
C-SSRS questionnaire will be used to monitor status of mental health of the participants.
Measured: Baseline to week 73 (EOS)
Change in Waist Circumference
Measured: Baseline, week 68
Change in Hip Circumference
Measured: Baseline, week 68
Change in Waist-to-hip Ratio
Measured: Baseline, week 68
Trough Concentration of Ecnoglutide
Measured: Week 1 to week 73 (EOS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start3 Aug 2026
- Primary completion31 May 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Sciwind Biosciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Weihua XU, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734311
- Sponsor's protocol ID
- SCW0502-6031
- Status last verified
- May 2026
- First submitted
- 21 Jul 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07734311
- Acronym / sponsor ID
- SCW0502-6031
- Conditions
- Knee Osteoarthritis, Obesity
- Keywords
- Ecnoglutide, KOA, Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Hangzhou Sciwind Biosciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Aug 2026 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of the study is to evaluate the efficacy and safety of ecnoglutide injections versus placebo in obese participants with KOA.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ecnoglutide Injection | Experimental | Drug: Ecnoglutide InjectionOnce weekly |
| Placebo | Placebo comparator | Drug: placebo with matching volumeOnce weekly |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ecnoglutide Injectionsubcutaneous injection | Drug | Ecnoglutide Injection |
| placebo with matching volumesubcutaneous injection | Drug | Placebo |
Primary outcome
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
Time frame: Baseline, week 68
Percentage Change in Body Weight
Time frame: Baseline, week 68
32 secondary outcomes
Percentage of Participants with ≥5% of Body Weight Loss
Time frame: Baseline, week 68
Percentage of Participants with ≥10% of Body Weight Loss
Time frame: Baseline, week 68
Percentage of Participants with ≥50% of Reduction in WOMAC Pain Subscale Score
Time frame: Baseline, week 68
Change in WOMAC Physical Function Subscale Score
Time frame: Baseline, week 68
Change in Short Form 36 (SF36) V2 Physical Function Subscale Score
Time frame: Baseline, week 68
Absolute Change in Body Weight
Time frame: Baseline, week 68
Percentage of Participants with ≥15% of Body Weight Loss
Time frame: Baseline, week 68
Change in WOMAC Total Score
Time frame: Baseline, week 68
Percentage of Participants with ≥50% of Reduction in WOMAC Physical Function Subscale Score
Time frame: Baseline, week 68
Change in SF36V2 Score
Time frame: Baseline, week 68
Change in PGI-S Pain and Function Score of the Target Knee Joint
Time frame: Baseline, week 68
Change in PGI-C Pain and Function Score of the Target Knee Joint
Time frame: Baseline, week 68
Change in Body Mass Index (BMI)
Time frame: Baseline, week 68
Change in Walking Distance During the 6-minute Walk Test
Time frame: Baseline, week 68
Percentage of Participants Using Allowed Analgesics During Wash Out
Time frame: Baseline, week 68
Amount of Allowed Analgesics Used During Wash Out
Time frame: Baseline, week 68
Percentage of Participants Using Analgesics
Time frame: Baseline, week 68
Change in Amount of Analgesics Used
Time frame: Baseline, week 68
Change in Lipid Profile
Time frame: Baseline, week 68
Change in Fasting Plasma Glucose (FPG)
Time frame: Baseline, week 68
Change in HbA1c
Time frame: Baseline, week 68
Change in Fasting Insulin
Time frame: Baseline, week 68
Change in Fasting C-peptide
Time frame: Baseline, week 68
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Time frame: Baseline, week 68
Change in Blood Pressure
Time frame: Baseline, week 68
Adverse events
Time frame: Week 1 to week 73 (EOS)
Change in Patient Health Questionnaire-9 (PHQ-9) Score
Time frame: Baseline to week 73 (EOS)
Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Time frame: Baseline to week 73 (EOS)
Change in Waist Circumference
Time frame: Baseline, week 68
Change in Hip Circumference
Time frame: Baseline, week 68
Change in Waist-to-hip Ratio
Time frame: Baseline, week 68
Trough Concentration of Ecnoglutide
Time frame: Week 1 to week 73 (EOS)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Weihua XU principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ecnoglutide Injection in people with Knee Osteoarthritis and Obesity, run by Hangzhou Sciwind Biosciences Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yao Li (010-67889255, ra@sciwindbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score (time frame: Baseline, week 68). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.