Sarcopenia, Sarcopenia in Elderly
Conditions
Keywords
sarcopenia
Brief 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.
Interventions
DRUGAMC6156 0.1mg
Oral administration of AMC6156 in tablet form at a dose of 0.1 mg once daily for 12 weeks.
DRUGAMC6156 0.3mg
Oral administration of AMC6156 in tablet form at a dose of 0.3 mg once daily for 12 weeks.
DRUGAMC6156 1.0mg
Oral administration of AMC6156 in tablet form at a dose of 1.0 mg once daily for 12 weeks.
DRUGPlacebo
Oral administration of placebo tablets matching AMC6156 in appearance, once daily for 12 weeks.
Sponsors
Animuscure Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Short Physical Performance Battery (SPPB) Score from Baseline to Week 12 | At Visit 1 (Screening), Visit 2 (Week 0, Baseline), Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12) |
Secondary
| Measure | Time frame |
|---|---|
| Change in Short Physical Performance Battery (SPPB) Score at Week 4 and Week 8 | At Visit 1 (Screening), Visit 2 (Week 0, Baseline), Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12) |
| Change in Timed Up and Go (TUG) Test Time | At Visit 2 (Week 0), Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12) |
| Change in Appendicular Skeletal Muscle Mass (ASM) Measured by DXA | At Visit 1 (Screening) and Visit 5 (Week 12) |
| Change in Handgrip Strength | At Visit 1 (Screening), Visit 2 (Week 0) ,Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12) |
| Change in SARC-F Score | At Visit 2 (Week 0) and Visit 5 (Week 12) |
| Change in Sarcopenia Quality of Life (SarQoL) Score | At Visit 2 (Week 0) and Visit 5 (Week 12) |
Countries
South Korea
Contacts
CONTACTJooyeon Kim
Outcome results
None listed