A Double-blind, Placebo Controlled, Randomized INTerventional Clinical Trial (SARA-INT)
Status:
Completed
Trial end date:
2021-01-20
Target enrollment:
Participant gender:
Summary
SARA-INT is a phase 2 interventional study performed in Europe and USA aimed to evaluate the
clinical benefits, safety and tolerability of the investigational drug BIO101 administered
orally for a six-month (26 weeks) duration to older patients, community dwelling men and
women aged ≥65 years, suffering from age-related sarcopenia (including sarcopenic obesity),
and at risk of mobility disability.
The double-blind, placebo controlled clinical trial will collect and analyse data on physical
performance and body composition and will specifically focus on the change of one functional
measurement, the gait speed measured during the 400MW test plus the change of a highly
standardised patient reported outcome (PRO), the physical function domain PF-10 at the SF-36
auto-evaluation questionnaire, in order to estimate the efficacy of BIO101 administered over
26 weeks, in preventing mobility disability in the target population.