Sarcopenia in ElderlyPhase 2PLH-2301_P2NCT07390552
A Study of PLH-2301 in Subjects With Sarcopenia
A Phase 2 study testing PLH-2301 in people with Sarcopenia in Elderly, run by Pluto Inc. at 5 sites in South Korea.
Trial summary
This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of PLH-2301 in subjects with sarcopenia. Eligible subjects aged 65 years and older will be randomized to receive placebo or one of three dose levels of PLH-2301 once daily for 12 weeks. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia in Elderly
- What is being tested?
- PLH-2301
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 8 May 2026to 30 Jun 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
- Male or female subjects aged 65 years or older at the time of consent
- Diagnosis of sarcopenia based on predefined diagnostic criteria
- Short Physical Performance Battery (SPPB) total score within the protocol-defined range at screening
- Stable body weight for at least 3 months prior to screening
- Able to walk independently with or without assistive devices
- Willing and able to comply with study procedures
- Provided written informed consent prior to any study-specific procedures
Who cannot join
- History of clinically significant neuromuscular or musculoskeletal disorders that could affect muscle function
- Uncontrolled cardiovascular, hepatic, renal, or metabolic disease
- Use of medications known to affect muscle mass or function within the protocol-defined washout period
- Participation in another interventional clinical trial within 3 months prior to screening
- Any medical or psychiatric condition that, in the investigator's opinion, would interfere with study participation
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
South Korea5 sites, 5 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do
Clinical Research Coordinator, +82-10-8140-8670, seungahyu0101@gmail.com
- Recruiting
Korea University Anam Hospital
Seoul, Seoul, 02841
Clinical Research Coordinator, +82-10-4981-6641, sy92675@naver.com
- Recruiting
Seoul St. Mary's Hospital
Seoul, Seoul, 06591
Clinical Research Coordinator, +82-10-3370-2206, t33702206@cmcnu.or.kr
- Recruiting
Korea University Guro Hospital
Seoul, Seoul, 08308
Clinical Research Coordinator, +82-10-5445-6587, grkmcgrfm001@kumc.or.kr
- Recruiting
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do
Clinical Research Coordinator, +82-10-4274-6399, nanjingmei@kakao.com
About this study
Official title: A Prospective, Randomized, Double-blinded, Placebo-controlled, 4-Parallel Arm, Multi-center, Phase 2 Trial to Evaluate Efficacy and Safety of Orally Administered PLH-2301 in Elderly Patients With Sarcopenia
This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of PLH-2301 in subjects with sarcopenia.
Eligible subjects aged 65 years and older will be randomized to receive placebo or one of three dose levels of PLH-2301 once daily for 12 weeks.
The primary objective is to assess the effect of PLH-2301 on physical function compared with placebo.
Read the detailed description
Sarcopenia is a progressive and generalized skeletal muscle disorder associated with loss of muscle strength, physical performance, and quality of life in older adults. Currently, there are limited approved pharmacological treatment options for sarcopenia.
This Phase 2 study is designed to evaluate the efficacy and safety of PLH-2301 in subjects with sarcopenia. Approximately 168 eligible subjects will be randomized in a 1:1:1:1 ratio to receive placebo or PLH-2301 at dose levels of 200 mg, 400 mg, or 600 mg administered orally once daily for 12 weeks.
The primary efficacy endpoint is the change from baseline in the Short Physical Performance Battery (SPPB) total score at Week 12. Secondary endpoints include changes in gait speed, chair stand performance, handgrip strength, appendicular skeletal muscle mass, and health-related quality of life. Safety will be assessed throughout the study by monitoring adverse events, laboratory tests, vital signs, and physical examinations.
- Conditions
- Sarcopenia in Elderly
- Being tested
- PLH-2301, 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.
PLH-2301Drug
PLH-2301 administered orally according to assigned dosing regimen.
PlaceboDrug
Matching placebo administered orally according to assigned dosing regimen.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Subjects receive placebo orally in the morning, afternoon, and evening for 12 weeks. Receives: Drug: Placebo |
| PLH-2301 200mg | Experimental | Subjects receive PLH-2301 in the morning and placebo in the afternoon and evening for 12 weeks. Receives: Drug: PLH-2301; Drug: Placebo |
| PLH-2301 400mg | Experimental | Subjects receive PLH-2301 in the morning and evening and placebo in the afternoon for 12 weeks. Receives: Drug: PLH-2301; Drug: Placebo |
| PLH-2301 600mg | Experimental | Subjects receive PLH-2301 in the morning, afternoon, and evening for 12 weeks. Receives: Drug: PLH-2301 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Short Physical Performance Battery (SPPB) total score
Change from baseline in the Short Physical Performance Battery (SPPB) total score.
The Short Physical Performance Battery is a composite measure of lower extremity function with total scores ranging from 0 to 12, where higher scores indicate better physical performance.
Measured: Baseline to Week 12
Secondary outcomes (5)
Change from baseline in gait speed
Change from baseline in chair stand test time as a component of physical performance
Measured: Baseline to Week 12
Change from baseline in chair stand test time
Change from baseline in chair stand test time as a component of physical performance
Measured: Baseline to Week 12
Change from baseline in handgrip strength
Change from baseline in handgrip strength measured using a dynamometer
Measured: Baseline to Week 12
Change from baseline in appendicular skeletal muscle mass
Change from baseline in appendicular skeletal muscle mass measured by bioelectrical impedance analysis
Measured: Baseline to Week 12
Change from baseline in Sarcopenia Quality of Life (SarQoL-K) total score
Change from baseline in the Sarcopenia Quality of Life questionnaire (SarQoL-K) total score.
The SarQoL-K total score ranges from 0 to 100, with higher scores indicating better quality of life.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start8 May 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 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
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pluto Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Symyoo
- Responsible party
- Sponsor
- Investigators
- Sun Ahe Lee, Study director, Pluto Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390552
- Sponsor's protocol ID
- PLH-2301_P2
- Acronym
- PLH-2301_P2
- Status last verified
- May 2026
- First submitted
- 29 Jan 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blinded, Placebo-controlled, 4-Parallel Arm, Multi-center, Phase 2 Trial to Evaluate Efficacy and Safety of Orally Administered PLH-2301 in Elderly Patients With Sarcopenia
- ClinicalTrials.gov ID
- NCT07390552
- Acronym / sponsor ID
- PLH-2301_P2 / PLH-2301_P2
- Conditions
- Sarcopenia in Elderly
- Keywords
- Sarcopenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Pluto Inc.Industry (pharma, biotech, devices)
- Collaborators
- Symyoo
- Study start
- 8 May 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 5 Feb 2026 (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 is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of PLH-2301 in subjects with sarcopenia.
Eligible subjects aged 65 years and older will be randomized to receive placebo or one of three dose levels of PLH-2301 once daily for 12 weeks.
The primary objective is to assess the effect of PLH-2301 on physical function compared with placebo.
Detailed description
Sarcopenia is a progressive and generalized skeletal muscle disorder associated with loss of muscle strength, physical performance, and quality of life in older adults. Currently, there are limited approved pharmacological treatment options for sarcopenia.
This Phase 2 study is designed to evaluate the efficacy and safety of PLH-2301 in subjects with sarcopenia. Approximately 168 eligible subjects will be randomized in a 1:1:1:1 ratio to receive placebo or PLH-2301 at dose levels of 200 mg, 400 mg, or 600 mg administered orally once daily for 12 weeks.
The primary efficacy endpoint is the change from baseline in the Short Physical Performance Battery (SPPB) total score at Week 12. Secondary endpoints include changes in gait speed, chair stand performance, handgrip strength, appendicular skeletal muscle mass, and health-related quality of life. Safety will be assessed throughout the study by monitoring adverse events, laboratory tests, vital signs, and physical examinations.
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboSubjects receive placebo orally in the morning, afternoon, and evening for 12 weeks. |
| PLH-2301 200mg | Experimental | Drug: PLH-2301, Drug: PlaceboSubjects receive PLH-2301 in the morning and placebo in the afternoon and evening for 12 weeks. |
| PLH-2301 400mg | Experimental | Drug: PLH-2301, Drug: PlaceboSubjects receive PLH-2301 in the morning and evening and placebo in the afternoon for 12 weeks. |
| PLH-2301 600mg | Experimental | Drug: PLH-2301Subjects receive PLH-2301 in the morning, afternoon, and evening for 12 weeks. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Male or female subjects aged 65 years or older at the time of consent
- Diagnosis of sarcopenia based on predefined diagnostic criteria
- Short Physical Performance Battery (SPPB) total score within the protocol-defined range at screening
- Stable body weight for at least 3 months prior to screening
- Able to walk independently with or without assistive devices
Key exclusion criteria (5 listed)
- History of clinically significant neuromuscular or musculoskeletal disorders that could affect muscle function
- Uncontrolled cardiovascular, hepatic, renal, or metabolic disease
- Use of medications known to affect muscle mass or function within the protocol-defined washout period
- Participation in another interventional clinical trial within 3 months prior to screening
- Any medical or psychiatric condition that, in the investigator's opinion, would interfere with study participation
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 |
|---|---|---|
| PLH-2301PLH-2301 administered orally according to assigned dosing regimen. | Drug | PLH-2301 200mg, PLH-2301 400mg, PLH-2301 600mg |
| PlaceboMatching placebo administered orally according to assigned dosing regimen. | Drug | PLH-2301 200mg, PLH-2301 400mg, Placebo |
Primary outcome
Change from baseline in Short Physical Performance Battery (SPPB) total score
Time frame: Baseline to Week 12
Change from baseline in the Short Physical Performance Battery (SPPB) total score. The Short Physical Performance Battery is a composite measure of lower extremity function with total scores ranging from 0 to 12, where higher scores indicate better physical performance.
5 secondary outcomes
Change from baseline in gait speed
Time frame: Baseline to Week 12
Change from baseline in chair stand test time
Time frame: Baseline to Week 12
Change from baseline in handgrip strength
Time frame: Baseline to Week 12
Change from baseline in appendicular skeletal muscle mass
Time frame: Baseline to Week 12
Change from baseline in Sarcopenia Quality of Life (SarQoL-K) total score
Time frame: Baseline to 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 12 May 2026.
- Individual participant dataSharing planned: No
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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.
Sun Ahe Lee study director
Pluto Inc.
5 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 PLH-2301 in people with Sarcopenia in Elderly, run by Pluto Inc. at 5 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 7 inclusion and 5 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 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 CRO PM (+82-70-4335-4755, mskim1@symyoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Short Physical Performance Battery (SPPB) total score (time frame: Baseline to 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 12 May 2026.