20-HYDROXYECDYSONE for Sarcopenia

Inclusion criteria

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

Exclusion criteria

• {"criterion_text":"- Non-menopaused women (however, ongoing hormonal replacement treatment is notan exclusion criterion)\n- Treatment with another investigational drug, 20-hydroxyecdysone food supplements,\n- Sarcopenia and/or muscle weakness occurring after bedrest or immobilization (with full recovery less than 6 month before screening).\n- 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).\n- Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months\n- Severe arthritis or osteoarthritis in the lower limbs which would impact abilityto perform 400 MWT.\n- Parkinson’s disease or other progressive neurological disorder\n- Lung disease requiring regular use of supplemental oxygen.\n- 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).\n- Chest pain, severe shortness of breath, or occurrence of other safety concernsduring the baseline functional tests such as the 400MW test.\n- Renal disease requiring dialysis or known renal insufficiency (moderate orsevere reduction of eGFR≤30 ml/min/1.73 m2, based on Cockroft & Gaultformula).\n- 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.\n- 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)."}

Primary endpoints

• {"endpoint_text":"- Time to onset of Major Mobility Disability (MMD)","definition_or_measurement_approach":"Time-to-event endpoint measuring time to onset of Major Mobility Disability (MMD); main objective refers to effect on the hazard of MMD."}

Secondary endpoints

• {"endpoint_text":"- Gait speed 4-m from Short Physical Performance Battery SSPB Change from Baseline (CFB) at week 52","definition_or_measurement_approach":"Change from baseline (CFB) at week 52 measured using 4-m gait speed from the SPPB."}
• {"endpoint_text":"- Handgrip Strength (HGS) CFB at week 52","definition_or_measurement_approach":"Change from baseline (CFB) at week 52 measured by handgrip strength."}
• {"endpoint_text":"- Sarcopenia – Quality of Life (SarQol) Patient Reported Outcome (PRO) CFB at week 52","definition_or_measurement_approach":"Change from baseline (CFB) at week 52 measured by the SarQol patient-reported outcome instrument."}

Methods

• Site-based recruitment via participating clinical sites (example site: Vrije Universiteit Brussel, Gerontology department).
• Advertising material: patient leaflet (French, Dutch) (document: K1 Advertising material_Patient leaflet_French_Biophytis and NL version).
• Advertising material: patient poster (French, Dutch) (documents: K2 Advertising material_Patient Poster_French_Biophytis and NL version).

Belgium

Earliest CTIS Part Ii Submission Date

20-05-2025

Latest Decision Or Authorization Date

13-08-2025

Processing Time Days

85

Number Of Sites

1

Number Of Participants

50

Primary sponsor

Full Name

Biophytis

Organisation Type

Pharmaceutical company

Country Of Registered Address

France