AMC6156 for older adults with sarcopenia
A Multicenter, Randomized, Double-Blind, Placebo-controlled, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of AMC6156 in Patients With Sarcopenia
This trial will try once-daily AMC6156 pills or a placebo for 12 weeks to see if they improve strength and mobility in older adults with sarcopenia.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Animuscure Inc. Industry-sponsored |
| Locations | 4 sites (Seongnam-si, Gyeonggi-do and 3 other locations) |
| Trial ID | NCT07072195 on ClinicalTrials.gov |
What this trial studies
Older adults diagnosed with sarcopenia will take one of three oral doses of AMC6156 or a matching placebo every day for 12 weeks. Movement and muscle strength (including handgrip and physical performance tests) and safety labs will be measured at regular visits. Participants will follow exercise and nutrition guidance during the treatment period. The trial compares outcomes across dose groups and monitors for adverse events.
Who should consider this trial
Good fit: Men aged 65 or older and postmenopausal women diagnosed with sarcopenia by low appendicular skeletal muscle mass plus low grip strength or reduced physical performance who can walk and follow exercise/nutrition guidance are ideal candidates.
Not a fit: People with serious organ disease, active conditions that cause muscle wasting (like ALS or Parkinson's), recent fractures or surgery limiting mobility, severe psychiatric or cognitive impairment, or very low vitamin D/hemoglobin are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, AMC6156 could improve muscle strength and mobility and reduce disability in older adults with sarcopenia.
How similar studies have performed: While exercise and nutrition interventions show benefit and a few drugs have shown modest effects, pharmacologic treatments for sarcopenia remain limited and new agents like AMC6156 are still largely unproven in large clinical trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seongnam-si, Gyeonggi-do and 3 other locations
- CHA Bundang Medical Center — Seongnam-si, Gyeonggi-do, South Korea (Recruiting)
- Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea (Not_yet_recruiting)
- Ajou University Hospital — Suwon, Gyeonggi-do, South Korea (Recruiting)
- Seoul National University Hospital — Seoul, Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Jooyeon Kim
- Email: yeoooonee@animuscure.com
- Phone: +82-70-4105-6414
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.