A Multicenter, Randomized, Double-Blind, Placebo-controlled, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of AMC6156 in Patients With Sarcopenia
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Republic of Korea
CHA Bundang Medical Center
RECRUITING
Seongnam-si
Seoul National University Bundang Hospital
NOT_YET_RECRUITING
Seongnam-si
Seoul National University Hospital
RECRUITING
Seoul
Ajou University Hospital
RECRUITING
Suwon
Contact Information
Primary
Jooyeon Kim
yeoooonee@animuscure.com
+82-70-4105-6414
Time Frame
Start Date: 2025-07-01
Estimated Completion Date: 2026-06
Participants
Target number of participants: 80
Treatments
Experimental: AMC6156 0.1mg Treatment Group
Experimental: AMC6156 0.3mg Treatment Group
Experimental: AMC6156 1.0mg Treatment Group
Placebo_comparator: Placebo Control Group
Related Therapeutic Areas
Sponsors
Leads: Animuscure Inc.