Health TrialsbyHealthPanel

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

ConditionParticipants 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Ribupatide Injection

    Drug

    Ribupatide Injection

  • Placebo

    Drug

    Placebo

Treatment groups

382 Participants
are divided into 2 treatment groups
Group A: Ribupatide InjectionExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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 outcomes

1

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

Time frame
from first dose to 68 weeks after treatment
2

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

Time frame
from first dose to 68 weeks after treatment
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fujian Shengdi Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: