NCT03452488

A Double-blind, Placebo-controlled, Randomized INTerventional Clinical Trial (SARA-INT)

Safety and Efficacy of BIO-101 175 mg b.i.d. and 350 mg b.i.d. 26-week Oral Administration to Patients Suffering From Age-related SARcopenia, Including Sarcopenic Obesity, Aged ≥65 Years and at Risk of Mobility Disability

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 233 (actual)
• Sponsor: Biophytis · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The main objective of the study is to evaluate the effect of two daily doses of BIO101 versus placebo on mobility function as measured by gait speed using the 400MW test. The absolute change from baseline in meters/second observed in each treatment group at 6 Month was compared to the placebo group. Due to the Covid pandemic \>50% of data at endpoint was missing, which may have affected the ability of the study to deliver the expected results. Additionally, although the planned duration of treatment was 6 months, it was extended up to 9 months for some participants as a result of the pandemic.

Detailed description

The aim of this phase 2 double-blind, placebo-controlled, randomized interventional clinical trial (SARA-INT) is to evaluate the safety and efficacy of BIO-101 175 mg b.i.d. and 350 mg b.i.d. 9 months oral administration to participants suffering from age-related sarcopenia, including sarcopenic obesity, aged ≥65 years and at risk of mobility disability. There are 3-arms (2 doses versus placebo). This comparative clinical trial evaluated the effects up to 9 month treatment duration, based on the hypothesis that physical function of sarcopenic, older participants with an initial degree of mobility disability (SPPB) may be improved by BIO101. Included participants were randomized in a 1:1:1 ratio, to one of the 3 arms of treatment in a blinded manner. The randomization was stratified by gender and by center. Based on absence of long-term toxicology data, the investigational drug exposure was initially capped at 6 months.

Conditions

• Sarcopenia
• Gait Disorders in Old Age
• Muscle Weakness

Interventions

Type	Name	Description
DRUG	BIO101	Oral capsules
DRUG	Placebo	Oral capsules

Timeline

• Start date: 2017-02-07
• Primary completion: 2020-04-26
• Completion: 2020-04-26
• First posted: 2018-03-02
• Last updated: 2024-10-01
• Results posted: 2024-10-01

Locations

22 sites across 2 countries: United States, Belgium

Regulatory

• FDA-regulated drug study