A Study of AMC6156 in People With Sarcopenia (NCT07072195) | Clinical Trial Compass
RecruitingPhase 2
A Study of AMC6156 in People With Sarcopenia
South Korea80 participantsStarted 2025-07-01
Plain-language summary
This clinical trial aims to find out whether AMC6156 can improve physical function and is safe in older adults with sarcopenia. Participants will take AMC6156 or a placebo daily for 12 weeks, and their movement, strength, and safety will be regularly monitored through tests and checkups.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Voluntary participation with written informed consent
* Male ≥ 65 years or postmenopausal female
* Diagnosed with sarcopenia:
* ASM \< 7.0 kg/m² (men) or \< 5.4 kg/m² (women)
* Plus low handgrip strength or SPPB ≤ 9
* MNA screening score ≥ 8
* Body weight ≥ 35 kg, BMI between 15-30 kg/m²
* Willing and able to follow exercise and nutrition guidance
Exclusion Criteria:
* Allergy to investigational drug
* History of GI bleeding, ulcers, or severe liver/kidney/heart disease
* QTc ≥ 450 ms with symptoms
* Severe COPD, uncontrolled diabetes or thyroid disease
* Diseases causing cachexia or muscle wasting (e.g., ALS, Parkinson's)
* Vitamin D deficiency (\<10 ng/mL), hemoglobin \<10 g/dL
* Severe psychiatric disorders or MMSE \< 21
* Inability to walk or recent fracture/surgery affecting mobility
* Use of prohibited medications or recent participation in other clinical trials
* Investigator deems the subject unsuitable for the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Short Physical Performance Battery (SPPB) Score from Baseline to Week 12