Health TrialsbyHealthPanel

A Study of AMC6156 in People With Sarcopenia

ConditionsSarcopenia in ElderlySarcopenia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorAnimuscure Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntary participation with written informed consent

Male ≥ 65 years or postmenopausal female

ASM < 7.0 kg/m² (men) or < 5.4 kg/m² (women)

Plus low handgrip strength or SPPB ≤ 9

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: AMC6156 0.1mg Treatment GroupExperimental treatment 1 intervention
Group B: AMC6156 0.3mg Treatment GroupExperimental treatment 1 intervention
Group C: AMC6156 1.0mg Treatment GroupExperimental treatment 1 intervention
Group D: Placebo Control GroupPlacebo comparator 1 intervention

Trial outcomes

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Animuscure Inc.

Lead sponsor

Source ClinicalTrials.gov
Apply now