Clinical trial
A Trial of Ribupatide Injection in Participants With Obesity and Knee Osteoarthritis
Opening soon · Phase 3 · 1 countries · Registry ID NCT07709910
Opening soonPhase 3Interventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionParticipants With Obesity and Knee Osteoarthritis
Full registry criteria
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.
Treatments and study arms
Ribupatide Injection
Drug
Ribupatide Injection
Placebo
Drug
Placebo
Primary outcomes
Change from baseline in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain score after 68 weeks of treatmentafter 68 weeks of continuous treatment, assessed every few weeks
Percentage change from baseline in body weight after 68 weeks of treatmentafter 68 weeks of continuous treatment, assessed every few weeks
Study locations
1 locations were listed when this page was built. The first 40 are shown.
Shanghai Sixth People's Hospital🇨🇳 Shanghai, Shanghai Municipality, China
Changqing ZhangPrincipal Investigator