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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
PLH-2301
DrugPLH-2301 administered orally according to assigned dosing regimen.
Placebo
DrugMatching placebo administered orally according to assigned dosing regimen.
Treatment groups
168 Participants
are divided into 4 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: PLH-2301 200mgExperimental treatment 2 interventions
Group C: PLH-2301 400mgExperimental treatment 2 interventions
Group D: PLH-2301 600mgExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline to Week 12Secondary outcomes
1
Change from baseline in gait speed
Change from baseline in chair stand test time as a component of physical performance
Time frame
Baseline to Week 122
Change from baseline in chair stand test time
Change from baseline in chair stand test time as a component of physical performance
Time frame
Baseline to Week 123
Change from baseline in handgrip strength
Change from baseline in handgrip strength measured using a dynamometer
Time frame
Baseline to Week 124
Change from baseline in appendicular skeletal muscle mass
Change from baseline in appendicular skeletal muscle mass measured by bioelectrical impedance analysis
Time frame
Baseline to Week 12Other outcomes
1
Treatment compliance rate
Compliance with study medication, dietary intervention, and exercise program was monitored throughout the study.
Time frame
Throughout the 12-week treatment periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
Pluto Inc.
Lead sponsor
Symyoo
Collaborator
Source ClinicalTrials.gov