Trial intelligence / Profile preview

AMC6156 in Patients With Sarcopenia

NCT07072195Phase 2

Key facts

Status: Recruiting
Start: Jul 2025
Primary completion: Oct 2026
Countries: 1
Sponsor: Animuscure
Modality: Small Molecules

Drugs: AMC6156
Conditions: Sarcopenia

Overview

Phase 2, randomised, double-blind trial of AMC6156 in Sarcopenia (4 arms), sponsored by Animuscure. Primary endpoint: Short Physical Performance Battery at 12 weeks. Started Jul 2025; status: recruiting.

Design

4 arms

Study design: RandomizedDouble-blind

AMC6156 0.1mg Treatment Group
AMC6156 0.1mg once daily
AMC6156 0.3mg Treatment Group
AMC6156 0.3mg once daily
AMC6156 1.0mg Treatment Group
AMC6156 1.0mg once daily
Placebo Control Group
Placebo once daily

Who it enrols

Older adults (males >= 65 years, postmenopausal females) diagnosed with sarcopenia (low ASM and low handgrip strength or SPPB <= 9), BMI 15-30, without severe comorbidities.

Endpoints

Primary

Short Physical Performance Battery12 weeks

Secondary

Short Physical Performance Battery8 weeks
Timed Up and Go12 weeks
Appendicular Skeletal Muscle Mass12 weeks
Handgrip Strength12 weeks
SARC-F12 weeks
Sarcopenia Quality of Life12 weeks

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