Clinical Study of TJ0113 Capsule in the Treatment of Patients With Sarcopenia

Sponsor
Hangzhou PhecdaMed Co., Ltd.
Study ID
NCT07620938
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Sarcopenia

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TJ0113 — DRUG
    100mg or 200 mg or 400 mg Capsule, Once Daily
  • 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

Study Details

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.

Key Dates

First listed
Jun 2, 2026
Start date
Jun 3, 2026
Status verified
May 2026
Primary completion
Aug 22, 2027
Completion
Oct 22, 2027

Study Design

Enrollment
204 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TJ0113 100mg
    Subjects will receive 100 mg of TJ0113 capsules for 26 consecutive weeks
  • Experimental: TJ0113 200mg
    Subjects will receive 200 mg of TJ0113 capsules for 26 consecutive weeks
  • Experimental: TJ0113 400mg
    Subjects will receive 400 mg of TJ0113 capsules for 26 consecutive weeks
  • Placebo Comparator: Placebo
    Subjects will receive 100mg or 200mg or 400 mg of placebo for 26 consecutive weeks

Primary Outcome Measure

Change from baseline in gait speed on the 400-meter Walk Test at Week 26 [ Time Frame: After 26 weeks of treatment ]

Central Contacts

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