A Randomized, Double-Blind, Multicenter, Placebo Parallel-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of TJ0113 Capsule in the Treatment of Patients With Sarcopenia
This study is a randomized, double-blind, multicenter, placebo parallel-controlled Phase II clinical study designed to evaluate the clinical efficacy and safety of TJ0113 Capsule in patients with sarcopenia. The entire study plans to enroll 204 participants with sarcopenia. Eligible participants will be stratified by age (\< 70 years or ≥ 70 years to ≤ 80 years or \> 80 years) and block-randomized in a 1:1:1:1 ratio into 4 groups (TJ0113 Capsule 100 mg dose group; TJ0113 Capsule 200 mg dose group; TJ0113 Capsule 400 mg dose group; placebo group), with 51 participants per group. Participants in the placebo group will then be re-randomized in a 1:1:1 ratio to the respective dose groups (100 mg, 200 mg, and 400 mg). After randomization, study participants will receive continuous oral administration for 26 weeks with efficacy and safety evaluations, followed by a 1-week follow-up period after the end of treatment.
• Voluntarily participate in the clinical study and sign the informed consent form (ICF), willing and able to comply with the study protocol (e.g., able to understand and complete questionnaires, adhere to visit schedules, and use study medication);
• Male or female aged ≥60 years at the time of signing the ICF;
• Meet the diagnostic criteria of the Guideline for Diagnosis and Treatment of Sarcopenia in China (2024 Edition), specifically as follows:
⁃ 1Low muscle mass: DXA measurement of muscle mass \< 7.0 kg/m2 in males / \< 5.4 kg/m2 in females, or BIA measurement of muscle mass \< 7.0 kg/m2 in males / \< 5.7 kg/m2 in females; 3.2Low muscle strength (grip strength \< 28.0 kg in males, grip strength \< 18.0 kg in females); and/or physical dysfunction (walking speed in free state \< 1 m/s, or 5 Times Sit-to-Stand Test ≥ 12 s, or Short Physical Performance Battery score ≤ 9).
• Able to complete the 400-meter Walk Test within 15 minutes without sitting down, leaning against a wall, requiring assistance from others, or using a walker or cane.
• Participants of childbearing potential (including spouses of male participants) must have no plans for pregnancy or sperm donation from the screening period until 6 months after the last dose, and must be willing to use at least one effective contraceptive method (see Appendix 1) for contraception.
• Individuals whose results from comprehensive physical examination, vital signs, routine laboratory tests (complete blood count, blood biochemistry, urinalysis, coagulation), 12-lead electrocardiogram, chest X-ray, etc., are normal, or although abnormal, are determined by the investigator to be in the following condition: conditions considered stable and controlled by the investigator,planned during the studypatients with chronic diseases (e.g., hypertension and hyperlipidemia controlled within normal range, well-controlled non-insulin-dependent diabetes, etc.) who are taking medication regularly according to the established regimen and whose condition does not affect the study observation indicators after enrollment; abnormal items in screening tests determined by the investigator to be related to the patient's age or the aforementioned chronic diseases.