A Study of PLH-2301 in Subjects With Sarcopenia
Recruiting
Phase 2
Interventional Study
Sarcopenia in Elderly
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 65 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 168 (estimated)
- Sponsor
- Pluto Inc. · Industry
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About This Trial
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 wi…
Trial Locations
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Eligibility Criteria
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 mo…
Contacts