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

NCT07709910 | Not Yet Recruiting Phase 3

• 1 other identifier: HRS9531-311
• Study Type: interventional
• Target: 382
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Participants With Obesity and Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Change from baseline in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain score after 68 weeks of treatment

  after 68 weeks of continuous treatment, assessed every few weeks

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

  after 68 weeks of continuous treatment, assessed every few weeks

Secondary Outcomes (9)

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

  from first dose to 68 weeks after treatment

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

  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);

  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);

  from first dose to 68 weeks after treatment

• Use of analgesics during the treatment period;

  from first dose up to week 72

Study Arms (2)

Ribupatide Injection

EXPERIMENTAL

Drug: Ribupatide Injection

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ribupatide Injection DRUG

Ribupatide Injection

Ribupatide Injection

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 、Voluntarily sign the informed consent form, agree to comply with the protocol requirements, and be willing and able to complete the study;
• 、Aged ≥18 years on the date of signing the informed consent form, male or female;
• 、BMI ≥28.0 kg/m² at screening;
• 、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;
• 、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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Yiming Li

CONTACT

+0518-82342973; yiming.li@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 17, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 17, 2026

Record last verified: 2026-07

Locations

CN (1)