Sarcopenia in ElderlyPhase 2NCT07072195
A Study of AMC6156 in People With Sarcopenia
A Phase 2 study testing AMC6156 0.1mg, AMC6156 0.3mg and AMC6156 1.0mg in people with Sarcopenia in Elderly and Sarcopenia, run by Animuscure Inc. at 4 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia in Elderly, Sarcopenia
- What is being tested?
- AMC6156 0.1mg, AMC6156 0.3mg and AMC6156 1.0mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 1 Jul 2025to 15 Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea4 sites, 4 recruiting
- Recruiting
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, 13496
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
- Recruiting
Seoul National University Hospital
Seoul, Seoul, 03080
- Recruiting
Ajou University Hospital
Suwon, Gyeonggi-do, 16499
About this study
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
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
- Being tested
- AMC6156 0.1mg, AMC6156 0.3mg, AMC6156 1.0mg, Placebo
- Keywords
- sarcopenia
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMC6156 0.1mgDrug
Oral administration of AMC6156 in tablet form at a dose of 0.1 mg once daily for 12 weeks.
AMC6156 0.3mgDrug
Oral administration of AMC6156 in tablet form at a dose of 0.3 mg once daily for 12 weeks.
AMC6156 1.0mgDrug
Oral administration of AMC6156 in tablet form at a dose of 1.0 mg once daily for 12 weeks.
PlaceboDrug
Oral administration of placebo tablets matching AMC6156 in appearance, once daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| AMC6156 0.1mg Treatment Group | Experimental | Not described Receives: Drug: AMC6156 0.1mg |
| AMC6156 0.3mg Treatment Group | Experimental | Not described Receives: Drug: AMC6156 0.3mg |
| AMC6156 1.0mg Treatment Group | Experimental | Not described Receives: Drug: AMC6156 1.0mg |
| Placebo Control Group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Short Physical Performance Battery (SPPB) Score from Baseline to Week 12
Measured: 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
Measured: 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
Measured: 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
Measured: At Visit 1 (Screening) and Visit 5 (Week 12)
Change in Handgrip Strength
Measured: 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
Measured: At Visit 2 (Week 0) and Visit 5 (Week 12)
Change in Sarcopenia Quality of Life (SarQoL) Score
Measured: At Visit 2 (Week 0) and Visit 5 (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start1 Jul 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcopenia in ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Animuscure Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072195
- Sponsor's protocol ID
- AMC6156_SP_P2A01
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2025
- Last updated
- 3 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07072195
- Acronym / sponsor ID
- AMC6156_SP_P2A01
- Conditions
- Sarcopenia in Elderly, Sarcopenia
- Keywords
- sarcopenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Animuscure Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 18 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMC6156 0.1mgOral administration of AMC6156 in tablet form at a dose of 0.1 mg once daily for 12 weeks. | Drug | AMC6156 0.1mg Treatment Group |
| AMC6156 0.3mgOral administration of AMC6156 in tablet form at a dose of 0.3 mg once daily for 12 weeks. | Drug | AMC6156 0.3mg Treatment Group |
| AMC6156 1.0mgOral administration of AMC6156 in tablet form at a dose of 1.0 mg once daily for 12 weeks. | Drug | AMC6156 1.0mg Treatment Group |
| PlaceboOral administration of placebo tablets matching AMC6156 in appearance, once daily for 12 weeks. | Drug | Placebo Control Group |
Primary outcome
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)
6 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AMC6156 0.1mg, AMC6156 0.3mg and AMC6156 1.0mg in people with Sarcopenia in Elderly and Sarcopenia, run by Animuscure Inc. at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jooyeon Kim (+82-70-4105-6414, yeoooonee@animuscure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.