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The study is being conducted to evaluate the efficacy and safety of Ribupatide Injection in participants with obesity and knee osteoarthritis, and to explore its improvement on knee joint structure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ribupatide Injection | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ribupatide Injection | Drug | Ribupatide Injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain score after 68 weeks of treatment | after 68 weeks of continuous treatment, assessed every few weeks | |
| Percentage change from baseline in body weight after 68 weeks of treatment | after 68 weeks of continuous treatment, assessed every few weeks |
| Measure | Description | Time Frame |
|---|---|---|
| After 68 weeks of treatment, changes from baseline in WOMAC joint function score; | from first dose to 68 weeks after treatment | |
| After 68 weeks of treatment, changes from baseline in WOMAC stiffness score; | from first dose to 68 weeks after treatment |
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Inclusion Criteria:
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1、Voluntarily sign the informed consent form, agree to comply with the protocol requirements, and be willing and able to complete the study;
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yiming Li | Contact | +0518-82342973 | yiming.li@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Sixth People's Hospital | Shanghai | Shanghai Municipality | 200233 | China |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Placebo |
| Drug |
Placebo |
|
| After 68 weeks of treatment, changes from baseline in Average Pain Intensity Numerical Rating Scale (API-NRS); | from first dose to 68 weeks after treatment |
| After 68 weeks of treatment, changes from baseline in Worst Pain Intensity Numerical Rating Scale (WPI-NRS); | from first dose to 68 weeks after treatment |
| Use of analgesics during the treatment period; | from first dose up to week 72 |
| After 68 weeks of treatment, changes from baseline in body weight | from first dose to 68 weeks after treatment |
| After 68 weeks of treatment, changes from baseline in body mass index (BMI) | from first dose to 68 weeks after treatment |
| After 68 weeks of treatment, changes from baseline in waist circumference | from first dose to 68 weeks after treatment |
| Adverse events (AE). | from first dose up to week 76 |
| D012216 |
| Rheumatic Diseases |