Participants With Obesity and Knee OsteoarthritisPhase 3NCT07709910
A Trial of Ribupatide Injection in Participants With Obesity and Knee Osteoarthritis
A Phase 3 study testing Ribupatide Injection in people with Participants With Obesity and Knee Osteoarthritis, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Participants With Obesity and Knee Osteoarthritis
- What is being tested?
- Ribupatide Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 382 participants
- Where
- 1 siteChina
- Study dates
- Jul 2026to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
- 1、Voluntarily sign the informed consent form, agree to comply with the protocol requirements, and be willing and able to complete the study;
- 2、Aged ≥18 years on the date of signing the informed consent form, male or female;
- 3、BMI ≥28.0 kg/m² at screening;
- 4、Self-reported dietary and exercise control for 3 months or more prior to screening, and body weight change (difference between maximum and minimum body weight within 3 months) ≤5.0 kg in the 3 months prior to screening;
- 5、Based on the American College of Rheumatology criteria, the clinical diagnosis is knee osteoarthritis, and the target knee joint X-ray examination shows a K-L grade of 2-3 at screening.
Who cannot join
- Existence of endocrine diseases that may significantly affect body weight;
- Existence of any conditions affecting gastric emptying;
- Known history of acute or chronic pancreatitis, pancreatic injury, acute cholecystitis, or symptomatic/treated gallbladder diseases;
- Known history or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2);
- Severe infection, major trauma, or major/medium surgery within 1 month prior to screening;
- History of severe cardiovascular or cerebrovascular diseases within 6 months prior to screening;
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- History of malignancy in any organ system within 5 years prior to screening;
- Existence or suspicion of depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illnesses;
- Known or suspected history of alcohol and/or drug abuse or addiction;
- Symptoms or signs of acute or chronic hepatitis, or any liver disease other than metabolic dysfunction-associated fatty liver disease;
- Existence of serious hematologic diseases or any conditions causing hemolysis or red blood cell instability;
- Existence of autoimmune diseases requiring systemic glucocorticoid or immunosuppressive therapy during the study period;
- Known or suspected allergy to GLP-1 and/or GIP receptor agonists or their excipients;
- Participation in any drug or medical device clinical trial within 3 months prior to screening;
- Blood donation or cumulative blood loss ≥400 mL within 3 months prior to screening, or receipt of blood transfusion within 3 months;
- Participants with mental incompetence or language impairments that prevent full understanding or participation in the trial process.
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
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
Changqing Zhang
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-parallel-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Ribupatide Injection in Participants With Obesity and Knee Osteoarthritis
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.
- Being tested
- Ribupatide Injection, Placebo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ribupatide InjectionDrug
Ribupatide Injection
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Ribupatide Injection | Experimental | Not described Receives: Drug: Ribupatide Injection |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain score after 68 weeks of treatment
Measured: after 68 weeks of continuous treatment, assessed every few weeks
Percentage change from baseline in body weight after 68 weeks of treatment
Measured: after 68 weeks of continuous treatment, assessed every few weeks
Secondary outcomes (9)
After 68 weeks of treatment, changes from baseline in WOMAC joint function score;
Measured: from first dose to 68 weeks after treatment
After 68 weeks of treatment, changes from baseline in WOMAC stiffness score;
Measured: from first dose to 68 weeks after treatment
After 68 weeks of treatment, changes from baseline in Average Pain Intensity Numerical Rating Scale (API-NRS);
Measured: 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);
Measured: from first dose to 68 weeks after treatment
Use of analgesics during the treatment period;
Measured: from first dose up to week 72
After 68 weeks of treatment, changes from baseline in body weight
Measured: from first dose to 68 weeks after treatment
After 68 weeks of treatment, changes from baseline in body mass index (BMI)
Measured: from first dose to 68 weeks after treatment
After 68 weeks of treatment, changes from baseline in waist circumference
Measured: from first dose to 68 weeks after treatment
Adverse events (AE).
Measured: from first dose up to week 76
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Participants With Obesity and Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Fujian Shengdi Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 382 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709910
- Sponsor's protocol ID
- HRS9531-311
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-parallel-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Ribupatide Injection in Participants With Obesity and Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07709910
- Acronym / sponsor ID
- HRS9531-311
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 382 participants (estimated)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2026 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 17 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ribupatide Injection | Experimental | Drug: Ribupatide Injection |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- -
- 1、Voluntarily sign the informed consent form, agree to comply with the protocol requirements, and be willing and able to complete the study;
- 2、Aged ≥18 years on the date of signing the informed consent form, male or female;
- 3、BMI ≥28.0 kg/m² at screening;
- 4、Self-reported dietary and exercise control for 3 months or more prior to screening, and body weight change (difference between maximum and minimum body weight within 3 months) ≤5.0 kg in the 3 months prior to screening;
Key exclusion criteria (16 listed)
- Existence of endocrine diseases that may significantly affect body weight;
- Existence of any conditions affecting gastric emptying;
- Known history of acute or chronic pancreatitis, pancreatic injury, acute cholecystitis, or symptomatic/treated gallbladder diseases;
- Known history or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2);
- Severe infection, major trauma, or major/medium surgery within 1 month 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 |
|---|---|---|
| Ribupatide InjectionRibupatide Injection | Drug | Ribupatide Injection |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Change from baseline in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain score after 68 weeks of treatment
Time frame: after 68 weeks of continuous treatment, assessed every few weeks
Percentage change from baseline in body weight after 68 weeks of treatment
Time frame: after 68 weeks of continuous treatment, assessed every few weeks
9 secondary outcomes
After 68 weeks of treatment, changes from baseline in WOMAC joint function score;
Time frame: from first dose to 68 weeks after treatment
After 68 weeks of treatment, changes from baseline in WOMAC stiffness score;
Time frame: from first dose to 68 weeks after treatment
After 68 weeks of treatment, changes from baseline in Average Pain Intensity Numerical Rating Scale (API-NRS);
Time frame: 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);
Time frame: from first dose to 68 weeks after treatment
Use of analgesics during the treatment period;
Time frame: from first dose up to week 72
After 68 weeks of treatment, changes from baseline in body weight
Time frame: from first dose to 68 weeks after treatment
After 68 weeks of treatment, changes from baseline in body mass index (BMI)
Time frame: from first dose to 68 weeks after treatment
After 68 weeks of treatment, changes from baseline in waist circumference
Time frame: from first dose to 68 weeks after treatment
Adverse events (AE).
Time frame: from first dose up to week 76
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 17 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 Ribupatide Injection in people with Participants With Obesity and Knee Osteoarthritis, run by Fujian Shengdi Pharmaceutical 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 6 inclusion and 16 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: opening soon, as of the sponsor's last update on 17 Jul 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 Yiming Li (+0518-82342973, yiming.li@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain score after 68 weeks of treatment (time frame: after 68 weeks of continuous treatment, assessed every few weeks). 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 17 Jul 2026.