Clinical Study of TJ0113 Capsule in the Treatment of Patients With Sarcopenia
ConditionSarcopenia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorHangzhou PhecdaMed Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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;
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.
Disqualifiers
Presence of any medical condition that may interfere with adequate participation in the study, including but not limited to: history of epilepsy or complications, hemolytic anemia, pulmonary embolism or history of malignancy;
Participants who have experienced a New York Heart Association (NYHA) Class III or above congestive heart failure, unstable angina pectoris, acute myocardial infarction, hemorrhagic stroke (stroke), and ischemic stroke (including transient ischemic attack) within 6 months before screening; or those who have undergone any percutaneous coronary intervention or coronary artery bypass grafting, heart valve repair/replacement; or those with severe arrhythmia as judged by the investigator at the time of screening;
Personal or family history of long QT syndrome, family history of sudden death before the age of 40 in first-degree relatives (parents, children, and siblings); and/or personal history of unexplained syncope within 1 year prior to screening; and/or based on resting ECG results at screening: QT interval corrected for heart rate using Fridericia's formula, QTcF > 450 ms (males), QTcF > 470 ms (females) [Fridericia's formula: QTc = QT/(RR0.33), where RR represents the standard heart rate value, calculated as 60 divided by heart rate];
Presence of uncontrolled hypertension at screening, defined as systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg (confirmed before randomization);
Trial design
Treatments tested in this trial
- TJ0113
- TJ0113
- TJ0113
- Placebo
Treatment groups
204 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov