SARA-31: A phase 3 trial to evaluate the efficacy and safety of BIO-101 in elderly patients suffering from severe SARcopeniA: an interventional, randomized double-blind placebo- controlled, clinical trial.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502417-28-01

Acronym

BIO101-CL07

Enrollment

Registered

2025-08-13

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcopenia

Brief summary

Time to onset of Major Mobility Disability (MMD)

Detailed description

Gait speed 4-m from Short Physical Performance Battery SSPB Change from Baseline (CFB) at week 52, Handgrip Strength (HGS) CFB at week 52, Sarcopenia – Quality of Life (SarQol) Patient Reported Outcome (PRO) CFB at week 52

Interventions

DRUGPlacebo hard capsules

DRUG20-hydroxyecdysone

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Time to onset of Major Mobility Disability (MMD)	—

Secondary

Measure	Time frame
Gait speed 4-m from Short Physical Performance Battery SSPB Change from Baseline (CFB) at week 52, Handgrip Strength (HGS) CFB at week 52, Sarcopenia – Quality of Life (SarQol) Patient Reported Outcome (PRO) CFB at week 52	—

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026