SarcopeniaPhase 2NCT07620938
Clinical Study of TJ0113 Capsule in the Treatment of Patients With Sarcopenia
A Phase 2 study testing TJ0113 in people with Sarcopenia, run by Hangzhou PhecdaMed Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- TJ0113
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 1 siteChina
- Study dates
- 12 Jun 2026to 22 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- Any medical condition that may interfere with adequate participation in the trial, including but not limited to the following: a history of epilepsy or complications, a history of hemolytic anemia, pulmonary embolism, or malignant tumors, or a positive tumor marker test result during the screening period that is assessed by the investigator as clinically significant;
- New York Heart Association (NYHA) Class III or above congestive heart failure, unstable angina pectoris, acute myocardial infarction, hemorrhagic stroke, ischemic stroke (including transient ischemic attack) occurring within 6 months prior to screening; or Within 6 months prior to screening, undergone percutaneous coronary intervention, coronary artery bypass grafting, or cardiac valve repair/replacement; or at the time of screening, the presence of ventricular tachycardia, ventricular fibrillation, polymorphic ventricular tachycardia, etc., as judged by the investigator that may be life-threatening or lead to hemodynamic instability arrhythmia;
- 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);
- During screening chest pain, severe dyspnea, or other safety issues occurring during functional testing (e.g., 400-meter walk test), as assessed by the investigator to be unsuitable for participation in this study;
- Presence of clinically significant hepatic impairment, defined as total bilirubin (TBIL) >2× upper limit of normal (ULN) and/or alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2× ULN;
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- Presence of clinically significant renal impairment (creatinine clearance rate [Ccr] <30 mL/min). The formula for calculating Ccr is provided in Appendix II;
- Suffering from underlying diseases that may cause malnutrition, including chronic diarrhea (defined as a significant increase in bowel movement frequency compared to usual habits [>3 times/day], lasting >4 weeks, or recurrent diarrhea with intervals of 2-4 weeks), Crohn's disease and other digestive system diseases, neuropsychiatric disorders such as anorexia nervosa, uncontrolled diabetes mellitus (fasting blood glucose >8.3 mmol/L after treatment) and other metabolic diseases, chronic obstructive pulmonary disease (Modified Medical Research Council Dyspnea Scale [MMRC] score ≥2), chronic heart failure (diagnosed according to the Chinese Guidelines for the Diagnosis and Treatment of Heart Failure, 2024, NYHA class III or above), and other chronic wasting diseases, which, in the investigator's judgment, make the patient unsuitable for participation in this study;
- Individuals with neuromuscular diseases (e.g., Parkinson's disease), or other muscle system disorders such as muscular atrophy or myositis that could affect the diagnostic parameters of sarcopenia;
- Patients with implanted cardiac pacemakers or stents who, upon investigator assessment, are deemed unsuitable for participation in this study (Note: BIA testing is not recommended for individuals with implanted electronic devices such as cardiac pacemakers);
- Individuals with physical disabilities or injuries/surgeries to the upper or lower limbswithin 3 months prior to screeningthat may affect grip strength or gait speed measurements;
- Participants with a history of severe allergy, or known hypersensitivity/allergic reaction or intolerance to any component of the investigational product;
- Use of drugs affecting bone and muscle metabolism (bisphosphonates, estrogens, calcitonin, teriparatide, long-term oral or injectable corticosteroids [use for ≥2 weeks or requiring long-term use as determined by the investigator]) within 7 days or 5 half-lives prior to screening, whichever is longer (Note: Patients who have received a stable dose of denosumab for ≥6 months prior to screening and do not intend to change the dose during the study are permitted for enrollment; patients who plan to receive stable doses of bone mineralization promoters such as calcium, vitamin D, active vitamin D and its analogs [including calcitriol, alfacalcidol, etc.] within 4 weeks prior to the first dose and during the study period are permitted for enrollment);
- Evidence of alcohol abuse (average weekly consumption of ≥14 units of alcohol, where 1 unit ≈ 360 mL of beer, or 45 mL of liquor, or 150 mL of wine) or alcohol dependence within 6 months before screening, which in the investigator's opinion would interfere with the participant's understanding or completion of the study;
- Patients with a history of drug dependence/substance abuse within the past 1 year prior to screening;
- Positive for hepatitis B surface antigen (HBsAg) with HBV-DNA ≥ 1000 copies/mL or 200 IU/mL, or positive for hepatitis C virus (HCV) antibody with HCV RNA ≥ the lower limit of detection of the study site, or positive for human immunodeficiency virus (HIV) antibody, or positive for Treponema pallidum antibody at screening;
- Participation in a clinical study involving administration of an investigational drug, device, or surgery within 3 months or 5 half-lives (whichever is longer) before the first dose;
- Inability to swallow oral medications, or, in the investigator's judgment, presence of any condition that could significantly affect drug absorption, distribution, metabolism, or excretion (e.g., active enteropathy, partial or complete intestinal obstruction, chronic diarrhea), or any condition that could pose a risk to the participant;
- Subjects who have a history of organ transplantation (excluding corneal transplantation);
- Donated blood (including blood products) (including blood products) or experienced blood loss ≥400 mL within 1 month prior to screening, or received a blood transfusion (including blood products);
- Pregnant or breastfeeding women;
- Other reasons deemed by the investigator that the participant has poor compliance or is unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yasu Zhang contact
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310006
About this study
Official title: 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.
- Conditions
- Sarcopenia
- Being tested
- TJ0113, Placebo
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TJ0113Drug
100mg or 200 mg or 400 mg Capsule, Once Daily
TJ0113Drug
100mg or 200 mg or 400 mg Capsule, Once Daily
TJ0113Drug
100mg or 200 mg or 400 mg Capsule, Once Daily
PlaceboDrug
Capsule, Once Daily
| Study group | Role | What they receive |
|---|---|---|
| TJ0113 100mg | Experimental | Subjects will receive 100 mg of TJ0113 capsules for 26 consecutive weeks Receives: Drug: TJ0113 |
| TJ0113 200mg | Experimental | Subjects will receive 200 mg of TJ0113 capsules for 26 consecutive weeks Receives: Drug: TJ0113 |
| TJ0113 400mg | Experimental | Subjects will receive 400 mg of TJ0113 capsules for 26 consecutive weeks Receives: Drug: TJ0113 |
| Placebo | Placebo comparator | Subjects will receive 100mg or 200mg or 400 mg of placebo for 26 consecutive weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in gait speed on the 400-meter Walk Test at Week 26
Measured: After 26 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start12 Jun 2026
- Primary completion22 Aug 2027 (estimated)
- Study completion22 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou PhecdaMed Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qin Zhang, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620938
- Sponsor's protocol ID
- TJJS01-601
- Status last verified
- Aug 2026
- First submitted
- 27 May 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07620938
- Acronym / sponsor ID
- TJJS01-601
- Conditions
- Sarcopenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Hangzhou PhecdaMed Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Jun 2026 (actual)
- Primary completion
- 22 Aug 2027 (estimated)
- Study completion
- 22 Oct 2027 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TJ0113 100mg | Experimental | Drug: TJ0113Subjects will receive 100 mg of TJ0113 capsules for 26 consecutive weeks |
| TJ0113 200mg | Experimental | Drug: TJ0113Subjects will receive 200 mg of TJ0113 capsules for 26 consecutive weeks |
| TJ0113 400mg | Experimental | Drug: TJ0113Subjects will receive 400 mg of TJ0113 capsules for 26 consecutive weeks |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will receive 100mg or 200mg or 400 mg of placebo for 26 consecutive weeks |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (22 listed)
- Any medical condition that may interfere with adequate participation in the trial, including but not limited to the following: a history of epilepsy or complications, a history of hemolytic anemia, pulmonary embolism, or malignant tumors, or a positive tumor marker test result during the screening period that is assessed by the investigator as clinically significant;
- New York Heart Association (NYHA) Class III or above congestive heart failure, unstable angina pectoris, acute myocardial infarction, hemorrhagic stroke, ischemic stroke (including transient ischemic attack) occurring within 6 months prior to screening; or Within 6 months prior to screening, undergone percutaneous coronary intervention, coronary artery bypass grafting, or cardiac valve repair/replacement; or at the time of screening, the presence of ventricular tachycardia, ventricular fibrillation, polymorphic ventricular tachycardia, etc., as judged by the investigator that may be life-threatening or lead to hemodynamic instability arrhythmia;
- 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);
- During screening chest pain, severe dyspnea, or other safety issues occurring during functional testing (e.g., 400-meter walk test), as assessed by the investigator to be unsuitable for participation in this study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TJ0113100mg or 200 mg or 400 mg Capsule, Once Daily | Drug | TJ0113 100mg |
| TJ0113100mg or 200 mg or 400 mg Capsule, Once Daily | Drug | TJ0113 200mg |
| TJ0113100mg or 200 mg or 400 mg Capsule, Once Daily | Drug | TJ0113 400mg |
| PlaceboCapsule, Once Daily | Drug | Placebo |
Primary outcome
Change from baseline in gait speed on the 400-meter Walk Test at Week 26
Time frame: After 26 weeks of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yasu Zhang contact
Qin Zhang principal investigator
First Affiliated Hospital of Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TJ0113 in people with Sarcopenia, run by Hangzhou PhecdaMed Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dong Liu (+86-571-88779811, dong.liu@phecdamed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.