A Trial of Ribupatide Injection in Participants With Obesity and Knee Osteoarthritis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorFujian Shengdi Pharmaceutical Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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);
Trial design
Treatments tested in this trial
- Ribupatide Injection
- Placebo
Treatment groups
382 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov