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New pill aims to help seniors regain strength and mobility

NCT ID NCT07390552

Disease control Sponsor: Pluto Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental oral medication, PLH-2301, in 168 adults aged 65 and older who have sarcopenia (age-related muscle loss). Participants take either a placebo or one of three doses daily for 12 weeks. The main goal is to see if the drug improves physical function, such as walking speed and balance, compared to placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 168 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

Sarcopenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sarcopenia in elderly

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Korea University Anam Hospital

    RECRUITING

    Seoul, Seoul, 02841, South Korea

  • Korea University Guro Hospital

    RECRUITING

    Seoul, Seoul, 08308, South Korea

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam-si, Gyeonggi-do, South Korea

  • Seoul St. Mary's Hospital

    RECRUITING

    Seoul, Seoul, 06591, South Korea

  • The Catholic University of Korea, St. Vincent's Hospital

    RECRUITING

    Suwon, Gyeonggi-do, South Korea

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