A Study of AMC6156 in People With Sarcopenia

NCT07072195 | Recruiting Phase 2

• 1 other identifier: AMC6156_SP_P2A01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

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.

Conditions

Sarcopenia in Elderly; Sarcopenia

Keywords

sarcopenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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)

Study Arms (4)

AMC6156 0.1mg Treatment Group

EXPERIMENTAL

Drug: AMC6156 0.1mg

AMC6156 0.3mg Treatment Group

EXPERIMENTAL

Drug: AMC6156 0.3mg

AMC6156 1.0mg Treatment Group

EXPERIMENTAL

Drug: AMC6156 1.0mg

Placebo Control Group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AMC6156 0.1mg DRUG

Oral administration of AMC6156 in tablet form at a dose of 0.1 mg once daily for 12 weeks.

AMC6156 0.1mg Treatment Group

AMC6156 0.3mg DRUG

Oral administration of AMC6156 in tablet form at a dose of 0.3 mg once daily for 12 weeks.

AMC6156 0.3mg Treatment Group

AMC6156 1.0mg DRUG

Oral administration of AMC6156 in tablet form at a dose of 1.0 mg once daily for 12 weeks.

AMC6156 1.0mg Treatment Group

Placebo DRUG

Oral administration of placebo tablets matching AMC6156 in appearance, once daily for 12 weeks.

Placebo Control Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Animuscure Inc.: lead

Study Sites (4)

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, 13496, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

NOT YET RECRUITING

Ajou University Hospital

Suwon, Gyeonggi-do, 16499, South Korea

RECRUITING

Seoul National University Hospital

Seoul, Seoul, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Jooyeon Kim

CONTACT

+82-70-4105-6414; yeoooonee@animuscure.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 18, 2025
• Study Start: July 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 29, 2025

Record last verified: 2025-07

Locations

KR (4)