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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TJ0113 100mg | Experimental | Subjects will receive 100 mg of TJ0113 capsules for 26 consecutive weeks |
|
| TJ0113 200mg | Experimental | Subjects will receive 200 mg of TJ0113 capsules for 26 consecutive weeks |
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| TJ0113 400mg | Experimental | Subjects will receive 400 mg of TJ0113 capsules for 26 consecutive weeks |
|
| Placebo | Placebo Comparator | Subjects will receive 100mg or 200mg or 400 mg of placebo for 26 consecutive weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TJ0113 | Drug | 100mg or 200 mg or 400 mg Capsule, Once Daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in gait speed on the 400-meter Walk Test at Week 26 | After 26 weeks of treatment |
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Inclusion Criteria:
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:
3.1Low 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.
Results of comprehensive physical examination, vital signs, routine laboratory tests (hematology, blood biochemistry, urinalysis, coagulation), 12-lead ECG, chest X-ray, etc., are normal or, if abnormal, are judged by the investigator to be in the following condition: chronic diseases (e.g., hypertension, hyperlipidemia controlled within normal range, well-controlled non-insulin-dependent diabetes mellitus, etc.) that are judged by the investigator to be stably controlled, with regular medication according to a defined regimen for 4 weeks before screening, and that do not affect the study observation parameters after enrollment; abnormal screening test items judged by the investigator to be related to the participant's age or the aforementioned chronic diseases.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dong Liu | Contact | +86-571-88779811 | dong.liu@phecdamed.com | |
| Yasu Zhang | Contact | yasu.zhang@phecdamed.com |
| Name | Affiliation | Role |
|---|---|---|
| Qin Zhang | Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310006 | China |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| TJ0113 |
| Drug |
100mg or 200 mg or 400 mg Capsule, Once Daily |
|
| TJ0113 | Drug | 100mg or 200 mg or 400 mg Capsule, Once Daily |
|
| Placebo | Drug | Capsule, Once Daily |
|
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |