A Study of AMC6156 in People With Sarcopenia

Animuscure Inc.

Status and phase: Enrolling; Phase 2

Conditions: Sarcopenia in Elderly; Sarcopenia

Treatments: Drug: AMC6156 0.3mg; Drug: AMC6156 0.1mg; Drug: AMC6156 1.0mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07072195

AMC6156_SP_P2A01

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 4 patient groups, including a placebo group

AMC6156 0.1mg Treatment Group

Experimental group

Treatment:

Drug: AMC6156 0.1mg

AMC6156 0.3mg Treatment Group

Experimental group

Treatment:

Drug: AMC6156 0.3mg

AMC6156 1.0mg Treatment Group

Experimental group

Treatment:

Drug: AMC6156 1.0mg

Placebo Control Group

Placebo Comparator group

Treatment:

Drug: Placebo