SYF5d0cac5322784de7a09c79c820cfce82

Not Yet RecruitingPhase 3

SARA-31: A phase 3 trial to evaluate the efficacy and safety...

Biophytis Source

Biophytis

CTIS (EMA)

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Study Type

interventional

Reported enrollment (type unavailable)

N/A

Locations

2 countries

Sites

1

Brief Summary

To evaluate the efficacy of BIO101 350 mg b.i.d. administered orally versus placebo on the hazard of major mobility disability (MMD) in non-disabled older patients suffering from sarcopenia.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: not yet recruiting
Reported enrollment (type unavailable): Not reported
Study completion date: Not reported
Date not reported
Listed locations: 2 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
May 9, 2025
Actual (reported)

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

Time to onset of Major Mobility Disability (MMD)

Secondary Outcomes (3)

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

Placebo hard capsulesType not reported

20-hydroxyecdysoneType not reported

Eligibility Criteria

Sexall

Age GroupsOlder Adult (65+)

You may qualify if:

Aged 65 and older.
Living in the community (living at home, able to walk outside)
Reporting a loss of motor function over the last year

Sponsors & Collaborators

Biophytis
Industrylead

Study Sites (1)

Vrije Universiteit Brussel

Jette, 1090, Belgium

Ivan Bautmans+3224774207 ivan.bautmans@vub.be

Central Study Contacts

medical desk

+330785041699 cendrine.tourette@biophytis.com

Study Design

Study Type: interventional
Phase: phase 3

Study Record Dates

First Submitted

May 9, 2025

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2022-502417-28-01
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-28 03:20:10 UTC

Documents

bio101-cl-07-protocol-v1_final_3 countries

NCT03405727

Improvement of Sarcopenia in Patients Following Two Different Diets

Not ApplicableWithdrawn

NCT03417609

Interest of a Tongue Strength Measurement in the Screening for Sarcopenia in Hospitalized Elderly Patients

Completed

NCT05008770

Trial in Elderly With Musculoskeletal Problems Due to Underlying Sarcopenia - Faeces to Unravel Gut and Inflammation Translationally

Unknown

NCT00690534

Insulin and Sarcopenia in the Elderly

Phase 1Completed

NCT03740061

Muscle Assessment Through Ultrasound in the Evaluation of Acute Sarcopenia

Unknown

NCT04772586

Sarcopenia and Mechanical Ventilation in Older Patients Admitted Due to COVID-19

Completed

Short Physical Performance Battery (SPPB) score between 3 (included) and 7 (included).

Able to complete the 400-m walk test within 15 min without sitting down, help fromanother person, or use of a walker, a cane is accepted.

Hand grip strength in the dominant hand <35.5 kg for men, <20 kg for women

Gait speed from 4-m walking test ≤ 0.8 m/s.

You may not qualify if:

Severe arthritis or osteoarthritis in the lower limbs which would impact abilityto perform 400 MWT.
Parkinson’s disease or other progressive neurological disorder
Lung disease requiring regular use of supplemental oxygen.
Severe cardiovascular disease(including New York Heart Association [NYHA]class III or IV congestive heart failure, clinically significant valvular disease,(history of cardiac arrest, presence of an implantable defibrillator, oruncontrolled angina).
Chest pain, severe shortness of breath, or occurrence of other safety concernsduring the baseline functional tests such as the 400MW test.
Renal disease requiring dialysis or known renal insufficiency (moderate orsevere reduction of eGFR≤30 ml/min/1.73 m2, based on Cockroft & Gaultformula).
Current use of anabolic drugs (e.g., testosterone); current use of Erythropoietin; current use of systemic corticosteroid agents (except local administration route, like eye drops or dermatologic formulations).
Treatment with another investigational drug, 20-hydroxyecdysone food supplements,
Sarcopenia and/or muscle weakness occurring after bedrest or immobilization (with full recovery less than 6 month before screening).
Start of participation in a structured physical/rehabilitation therapy less than 3 months before screening (except for passive physical therapy. However, this should not be initiated the week before an evaluation visit and once started, it should be maintained over the study duration).
Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months

Contact the study team to confirm eligibility.

Biophytis_Protocol_BIO101-CL-07_final_20230712_trk

BIO 101CL07 SARA31 ENG synopsis 17 April 2023 final

BIO 101CL07 SARA31 FR synopsis 21 April 2023 final

BIO 101CL07 SARA31 DE synopsis 21 April 2023 final

BIO 101CL07 SARA31 NL synopsis 21 April 2023 final

D1 protocol synopsis CT2022-502417-28-01_DE

D1 protocol synopsis CT2022-502417-28-01_NL

D1 protocol synopsis CT2022-502417-28-01_FR

K1 Advertising material_Patient leaflet_French_Biophytis

K1_Advertising_material-Patient_leaflet-NL-Biophytis

K2 Advertising material_Patient Poster_French_Biophytis

K2 Advertising material_Patient Poster_NL_Biophytis

L3 BIO101-CL07_Master_PK sampling_ICF_FR

L3 BIO101-CL07_Master_PK sampling_ICF_DE

L3 BIO101-CL07_Master_PK_sampling_ICF_NL

L1-BIO101-CL07 Main ICF_V3 Belgium BAREC 18 avr 25_DE Final_clean

L1-BIO101-CL07 Main ICF_V3 Belgium BAREC 18 avr 25_DE Final_trackchanges

L1-BIO101-CL07 Main ICF_V3 Belgium BAREC 18 avr 25_Fre Final_clean

L1-BIO101-CL07 Main ICF_V3 Belgium BAREC 18 avr 25_Fre Final_trackchanges

L1-BIO101-CL07 Main ICF_V3 Belgium BAREC 18 avr 25NL Final_clean

L1-BIO101-CL07 Main ICF_V3 Belgium BAREC 18 avr 25NL Final_trackchanges

L2 BIO101-CL07_Biobanking_ICF_V2_7 Apr 2025_Fre_FINAL

L4-BIO101-CL07_Pregnant partner_ICF_V1_final EN 16 Apr 2025 final fr

L2 BIO101-CL07_Biobanking_ICF_V2_7Apr_2025 -NL_ FINAL

L4-BIO101-CL07_Pregnant partner_ICF_V1_final EN 16 Apr 2025 final nl

L2 BIO101-CL07_Biobanking_ICF_V2 -7 Apr 2025_DE_final

L3 ICF Procedure BE Biophytis

L4-BIO101-CL07_Pregnant partner_ICF_V1_final EN 16 Apr 2025 final de

Locations

BE(1)US(0)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations