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Not yet recruitingPhase 3

A Trial of Ribupatide Injection in Participants With Obesity and Knee Osteoarthritis

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

Asset

HRS9531

GLP-1 / GIP dual

Listed sites

1

Recruiting sites

-

Estimated enrollment

382

Study population

Obesity / overweight, Osteoarthritis

Eligibility highlights

•BMI ≥28

Primary endpoints

•WOMAC pain score after 68 weeks of treatment•Body weight after 68 weeks of treatment

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 IDNCT07709910
Org study IDHRS9531-311

Timeline

Milestones

Study first posted2026-07-17actual
Last update posted2026-07-17actual
Study start2026-07estimated (month precision)
Primary completion2028-11estimated (month precision)
Study completion2028-12estimated (month precision)

Assets

Investigational agents

Who this study enrolls

Obesity / overweightOsteoarthritis

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1、Voluntarily sign the informed consent form, agree to comply with the protocol requirements, and be willing and able to complete the study;

1. 2、Aged ≥18 years on the date of signing the informed consent form, male or female;

2. 3、BMI ≥28.0 kg/m² at screening;

3. 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;

4. 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.

Exclusion criteria

1. Existence of endocrine diseases that may significantly affect body weight;

2. Existence of any conditions affecting gastric emptying;

3. Known history of acute or chronic pancreatitis, pancreatic injury, acute cholecystitis, or symptomatic/treated gallbladder diseases;

4. Known history or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2);

5. Severe infection, major trauma, or major/medium surgery within 1 month prior to screening;

6. History of severe cardiovascular or cerebrovascular diseases within 6 months prior to screening;

7. History of malignancy in any organ system within 5 years prior to screening;

8. Existence or suspicion of depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illnesses;

9. Known or suspected history of alcohol and/or drug abuse or addiction;

10. Symptoms or signs of acute or chronic hepatitis, or any liver disease other than metabolic dysfunction-associated fatty liver disease;

11. Existence of serious hematologic diseases or any conditions causing hemolysis or red blood cell instability;

12. Existence of autoimmune diseases requiring systemic glucocorticoid or immunosuppressive therapy during the study period;

13. Known or suspected allergy to GLP-1 and/or GIP receptor agonists or their excipients;

14. Participation in any drug or medical device clinical trial within 3 months prior to screening;

15. Blood donation or cumulative blood loss ≥400 mL within 3 months prior to screening, or receipt of blood transfusion within 3 months;

16. Participants with mental incompetence or language impairments that prevent full understanding or participation in the trial process.

Endpoints (11)

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)
6
Weight & body composition
4
Safety / tolerability / PK
1

Weight & body composition

4 endpoints
Primary/protocol endpoint

Percentage change from baseline in body weight after 68 weeks of treatment

Time frame:after 68 weeks of continuous treatment, assessed every few weeks

percent change from baseline, improvement

Secondary/protocol endpoint

After 68 weeks of treatment, changes from baseline in body weight

Time frame:from first dose to 68 weeks after treatment

descriptive

Secondary/protocol endpoint

After 68 weeks of treatment, changes from baseline in body mass index (BMI)

Time frame:from first dose to 68 weeks after treatment

descriptive

Secondary/protocol endpoint

After 68 weeks of treatment, changes from baseline in waist circumference

Time frame:from first dose to 68 weeks after treatment

descriptive

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Adverse events (AE).

Time frame:from first dose up to week 76

descriptive

Other (unclassified)

6 endpoints
Primary/protocol endpoint/low confidence

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

change from baseline, improvement

Secondary/protocol endpoint/low confidence

After 68 weeks of treatment, changes from baseline in WOMAC joint function score;

Time frame:from first dose to 68 weeks after treatment

descriptive

Secondary/protocol endpoint/low confidence

After 68 weeks of treatment, changes from baseline in WOMAC stiffness score;

Time frame:from first dose to 68 weeks after treatment

descriptive

Secondary/protocol endpoint/low confidence

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

descriptive

Secondary/protocol endpoint/low confidence

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

descriptive

Secondary/protocol endpoint/low confidence

Use of analgesics during the treatment period;

Time frame:from first dose up to week 72

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.