A Study of PLH-2301 in Subjects With Sarcopenia
ConditionSarcopenia in Elderly
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorPluto Inc.
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 with placebo.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- PLH-2301
- Placebo
Treatment groups
168 Participants
are divided into 4 treatment groupsSponsors and collaborators
Pluto Inc.
Lead sponsor
Symyoo
Collaborator
Source ClinicalTrials.gov