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

NCT07620938 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2026-08-05

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

TJ0113

100mg or 200 mg or 400 mg Capsule, Once Daily

DRUG

TJ0113

100mg or 200 mg or 400 mg Capsule, Once Daily

DRUG

TJ0113

100mg or 200 mg or 400 mg Capsule, Once Daily

DRUG

Placebo

Capsule, Once Daily

Sponsors & Collaborators

  • Hangzhou PhecdaMed Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Qin Zhang · First Affiliated Hospital of Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-12
Primary Completion
2027-08-22
Completion
2027-10-22

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07620938 on ClinicalTrials.gov