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Recruiting NCT07072195

A Study of AMC6156 in People With Sarcopenia

Phase II Interventional Sarcopenia in Elderly Sarcopenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AMC6156 0.1mg, AMC6156 0.3mg, AMC6156 1.0mg, Placebo.
Who it may be relevant to
Registry conditions: Sarcopenia in Elderly, Sarcopenia. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug AMC6156 0.1mg
    Oral administration of AMC6156 in tablet form at a dose of 0.1 mg once daily for 12 weeks.
  • Drug AMC6156 0.3mg
    Oral administration of AMC6156 in tablet form at a dose of 0.3 mg once daily for 12 weeks.
  • Drug AMC6156 1.0mg
    Oral administration of AMC6156 in tablet form at a dose of 1.0 mg once daily for 12 weeks.
  • Drug Placebo
    Oral administration of placebo tablets matching AMC6156 in appearance, once daily for 12 weeks.

Primary outcome measures

  • 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 outcome measures (6)
  • 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)]
  • 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)]
  • Change in Appendicular Skeletal Muscle Mass (ASM) Measured by DXA [Time frame: At Visit 1 (Screening) and Visit 5 (Week 12)]
  • 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)]
  • Change in SARC-F Score [Time frame: At Visit 2 (Week 0) and Visit 5 (Week 12)]
  • Change in Sarcopenia Quality of Life (SarQoL) Score [Time frame: At Visit 2 (Week 0) and Visit 5 (Week 12)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

South Korea · 4 centers
  • CHA Bundang Medical Center — Seongnam-si
  • Seoul National University Bundang Hospital — Seongnam-si
  • Ajou University Hospital — Suwon
  • Seoul National University Hospital — Seoul

Identifiers

NCT: NCT07072195 · AMC6156_SP_P2A01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗