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

Inclusion criteria

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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.