Not yet recruiting NCT07709910
A Trial of Ribupatide Injection in Participants With Obesity and Knee Osteoarthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ribupatide Injection, Placebo.
- Who it may be relevant to
- Registry conditions: Participants With Obesity and Knee Osteoarthritis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug Ribupatide Injection
Ribupatide Injection - Drug Placebo
Placebo
Primary outcome measures
- 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]
Secondary outcome measures (9)
- 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]
Eligibility 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;
- 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.
Exclusion criteria
- 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;
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Sixth People's Hospital — Shanghai
Identifiers
NCT: NCT07709910 · HRS9531-311