Actively Recruiting
A Multicenter, Randomized, Double-Blind, Placebo-controlled Phase 2 Trial to Evaluate AMC6156 for Sarcopenia in Older Adults
Led by Animuscure Inc. · Updated on 2025-07-29
80
Participants Needed
4
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of AMC6156 on physical function and safety in older adults diagnosed with sarcopenia, a condition characterized by reduced muscle mass and strength. This phase 2 clinical trial aims to determine if AMC6156 can improve movement and muscle strength in this population. The study is randomized, double-blind, and placebo-controlled, ensuring reliable comparison between treatment groups. Participants will be randomly assigned to one of four groups: receiving AMC6156 at doses of 0.1 mg, 0.3 mg, or 1.0 mg once daily, or a matching placebo, all taken orally for 12 weeks. The study includes regular visits at screening, baseline, and weeks 4, 8, and 12 to monitor progress and safety throughout the treatment period. During the study, participants will undergo tests to measure physical performance using the Short Physical Performance Battery (SPPB), Timed Up and Go (TUG) test, handgrip strength, and muscle mass via DXA scans. Quality of life and sarcopenia-specific assessments will also be completed. Safety evaluations and monitoring will occur at regular intervals, with total participation lasting approximately 12 weeks.
CONDITIONS
Brief Title
A Study of AMC6156 in People With Sarcopenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with written informed consent
- Male aged 65 years or older, or postmenopausal female
- Diagnosed with sarcopenia with appendicular skeletal muscle mass less than 7.0 kg/m² for men or less than 5.4 kg/m² for women
- Low handgrip strength or Short Physical Performance Battery (SPPB) score of 9 or less
- Mini Nutritional Assessment (MNA) screening score of 8 or higher
- Body weight of at least 35 kg and body mass index (BMI) between 15 and 30 kg/m²
- Willing and able to follow exercise and nutrition guidance
You will not qualify if you...
- Allergy to the investigational drug
- History of gastrointestinal bleeding, ulcers, or severe liver, kidney, or heart disease
- QTc interval of 450 ms or more with symptoms
- Severe chronic obstructive pulmonary disease (COPD), uncontrolled diabetes, or thyroid disease
- Diseases causing cachexia or muscle wasting such as amyotrophic lateral sclerosis (ALS) or Parkinson's disease
- Vitamin D deficiency below 10 ng/mL or hemoglobin less than 10 g/dL
- Severe psychiatric disorders or Mini-Mental State Examination (MMSE) score below 21
- Inability to walk or recent fracture or surgery affecting mobility
- Use of prohibited medications or recent participation in other clinical trials
- Investigator's judgment deeming the subject unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive oral AMC6156 or placebo tablets once daily for 12 weeks.
5 visits (Baseline at Week 0, Week 4, Week 8, Week 12, plus Screening visit not included here)
Trial Site Locations
Total: 4 locations
1
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea, 13496
Actively Recruiting
2
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620
Not Yet Recruiting
3
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea, 16499
Actively Recruiting
4
Seoul National University Hospital
Seoul, Seoul, South Korea, 03080
Actively Recruiting
Research Team
J
Jooyeon Kim
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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