RecruitingPhase 2NCT07390552

A Study of PLH-2301 in Subjects With Sarcopenia

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

Sponsor

Pluto Inc.

Enrollment

168 participants

Start Date

May 8, 2026

Study Type

INTERVENTIONAL

Conditions

Sarcopenia in Elderly

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. The primary objective is to assess the effect of PLH-2301 on physical function compared with placebo.

Eligibility

Min Age: 65 Years

Inclusion Criteria7

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 Criteria5

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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