AMC6156 for older adults with sarcopenia
Official title: A Multicenter, Randomized, Double-Blind, Placebo-controlled, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of AMC6156 in Patients With Sarcopenia
Run by Animuscure Inc. · NCT07072195 · Data updated 2026-11-12
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 |
| Ages | 65 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Animuscure Inc. Industry-sponsored |
| Locations | 4 sites (Seongnam-si, Gyeonggi-do and 3 other locations) |
| Status | Recruiting |
| Started | July 1, 2025 |
| Main results expected | October 31, 2026 |
| Study ends | February 15, 2027 |
| Registry record updated | August 3, 2026 |
| Trial ID | NCT07072195 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea Recruiting -
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea 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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.