A Phase 2 Clinical Trial Evaluating the Safety and Efficacy of AMC6156 in People With Sarcopenia

Launched by ANIMUSCURE INC. · Jul 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called AMC6156 to see if it can help improve muscle strength and physical abilities in older adults who have sarcopenia, a condition where muscles become weak and smaller with age. The study also wants to make sure the medicine is safe to use. Participants will take either AMC6156 or a dummy pill (placebo) every day for 12 weeks. During this time, doctors will regularly check their strength, movement, and overall health through tests and visits.

To join the trial, participants need to be men aged 65 or older or women who are past menopause, and they must have been diagnosed with sarcopenia based on muscle size and strength tests. They should also be generally healthy enough to follow exercise and nutrition advice provided during the study. People with serious health problems, allergies to the study drug, or recent surgeries affecting movement won’t be able to join. If you or a loved one fits these criteria, this study could offer a chance to try a new treatment aimed at improving muscle health and daily function.

Gender

ALL

Eligibility 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