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
Lead sponsor
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
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
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
Weight & body composition
4 endpointsPercentage 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
After 68 weeks of treatment, changes from baseline in body weight
Time frame:from first dose to 68 weeks after treatment
descriptive
After 68 weeks of treatment, changes from baseline in body mass index (BMI)
Time frame:from first dose to 68 weeks after treatment
descriptive
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 endpointAdverse events (AE).
Time frame:from first dose up to week 76
descriptive
Other (unclassified)
6 endpointsChange 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
After 68 weeks of treatment, changes from baseline in WOMAC joint function score;
Time frame:from first dose to 68 weeks after treatment
descriptive
After 68 weeks of treatment, changes from baseline in WOMAC stiffness score;
Time frame:from first dose to 68 weeks after treatment
descriptive
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
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
Use of analgesics during the treatment period;
Time frame:from first dose up to week 72
descriptive
Provenance
Sources
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.