Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07072195

A Study of AMC6156 in People With Sarcopenia

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHA Bundang Medical Center, Seongnam-si, Gyeonggi-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AMC6156 0.1mg

Drug

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

AMC6156 0.3mg

Drug

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

AMC6156 1.0mg

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Change in Short Physical Performance Battery (SPPB) Score from Baseline to Week 12

    Time frame: At Visit 1 (Screening), Visit 2 (Week 0, Baseline), Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12)

Secondary outcomes

  1. Change in Short Physical Performance Battery (SPPB) Score at Week 4 and Week 8

    Time frame: At Visit 1 (Screening), Visit 2 (Week 0, Baseline), Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12)

  2. Change in Timed Up and Go (TUG) Test Time

    Time frame: At Visit 2 (Week 0), Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12)

  3. Change in Appendicular Skeletal Muscle Mass (ASM) Measured by DXA

    Time frame: At Visit 1 (Screening) and Visit 5 (Week 12)

  4. Change in Handgrip Strength

    Time frame: At Visit 1 (Screening), Visit 2 (Week 0) ,Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12)

  5. Change in SARC-F Score

    Time frame: At Visit 2 (Week 0) and Visit 5 (Week 12)

  6. Change in Sarcopenia Quality of Life (SarQoL) Score

    Time frame: At Visit 2 (Week 0) and Visit 5 (Week 12)

Study contacts

Contact information is provided by the study sponsor or research team.

Jooyeon Kim

CONTACT

[email protected]

+82-70-4105-6414

Sponsors and collaborators

Lead sponsor

Animuscure Inc.

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Placebo-controlled, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of AMC6156 in Patients With Sarcopenia

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 18, 2025
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.