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.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Biophytis

Participant type

Patients

Age range

65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Decision date (initial)

2025-08-13

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Biophytis S.A.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

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.

Secondary objectives 2

1. To assess the efficacy of BIO101 treatment versus placebo for a minimum of 52 weeks (365 days) on relevant health-related outcomes in non-disabled older patients suffering from sarcopenia and at the end of the follow-up period.These include physical performance and quality of life. To assess the safety and tolerability of BIO101.
2. To assess the safety and tolerability of BIO101.

Conditions and MedDRA coding

Sarcopenia

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Aged 65 and older.
2. Living in the community (living at home, able to walk outside)
3. Reporting a loss of motor function over the last year
4. Short Physical Performance Battery (SPPB) score between 3 (included) and 7 (included).
5. 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.
6. Hand grip strength in the dominant hand <35.5 kg for men, <20 kg for women
7. Gait speed from 4-m walking test ≤ 0.8 m/s.

Exclusion criteria 13

1. Non-menopaused women (however, ongoing hormonal replacement treatment is notan exclusion criterion)
2. Severe arthritis or osteoarthritis in the lower limbs which would impact abilityto perform 400 MWT.
3. Parkinson’s disease or other progressive neurological disorder
4. Lung disease requiring regular use of supplemental oxygen.
5. 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).
6. Chest pain, severe shortness of breath, or occurrence of other safety concernsduring the baseline functional tests such as the 400MW test.
7. Renal disease requiring dialysis or known renal insufficiency (moderate orsevere reduction of eGFR≤30 ml/min/1.73 m2, based on Cockroft & Gaultformula).
8. History or active signs or symptoms of gallbladder/biliary disease (e.g., previousepisodes of cholestasis/biliary tract obstruction, cholelithiasis, cholecystitis,etc.). Of note, history of cholecystectomy and no active biliary signs orsymptoms, is not an exclusion criterion.
9. 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).
10. Treatment with another investigational drug, 20-hydroxyecdysone food supplements,
11. Sarcopenia and/or muscle weakness occurring after bedrest or immobilization (with full recovery less than 6 month before screening).
12. 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).
13. Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Time to onset of Major Mobility Disability (MMD)

Secondary endpoints 3

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Biophytis

Sponsor organisation

Biophytis

Address

14 Avenue De L Opera

City

Paris

Postcode

75001

Country

France

Scientific contact point

Organisation

Biophytis

Contact name

medical desk

Public contact point

Organisation

Biophytis

Contact name

medical desk

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 29 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications