Sarcopenia including sarcopenic obesity MedDRA version: 20.1 Level: PT Classification code 10063024 Term: Sarcopenia System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Code: BIO-101
Pharmaceutical Form: Capsule
INN or Proposed INN: BIO101
CAS Number: 5289-74-7
Current Sponsor code: BIO101
Other descriptive name: 20-hydroxyecdysone
Concentration unit: mg mill
Sponsors
Biophytis S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of signed and dated informed consent form (ICF) 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female aged = 65 years, living in the community (living at home, able to walk outside from time to time. Homes can include any living community that may or may not offer optional services for the convenience of the residents. Older adults living in nursing homes or in medicalized residences where caretaker services are mandatory are not eligible) and reporting a loss of physical function over the last 6-12 months 4. SPPB score = 8 5. ALM/BMI =65 years) yes F.1.3.1 Number of subjects for this age range 231
Exclusion criteria
Exclusion criteria: 1. Current use of anabolic drugs (e.g. testosterone); current use of Erythropoietin; current use of corticosteroid agents (except ocal administration route, like eye drops or dermatologic formulations) 2. Non-menopaused women (however, ongoing hormonal replacement hormonal treatment is not an exclusion criterion) 3. Known allergic reactions to sourcing components of the investigational drug (i.e. Cyanotis species; e.g. Cyanotis arachnoidea C.B. Clarke or Cyanotis vaga Lour. (Shultes) leaves and roots) 4. Treatment with another investigational drug or other interventions within three months 5. Unable to understand and perform the functional tests, as judged by the Investigator 6. Inability to perform the 400MW test within 15 minutes 7. Clinical conditions: a. Current diagnosis of major psychiatric disorders. b. Alcohol abuse or dependence c. Severe arthritis d. Cancer requiring active treatment (cancer previously treated with chemotherapy and/or radiotherapy and participants currently on remission is not an exclusion criterion) e. Lung disease requiring regular use of supplemental oxygen f. Inflammatory conditions requiring regular use of oral or parenteral corticosteroid agents g. 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, or uncontrolled angina) h. Parkinson’s disease or other progressive neurological disorder i. Renal disease requiring dialysis, or known renal insufficiency (moderate or severe reduction of eGFR=30 ml/min/1.73 m2, based on Cockroft & Gault formula) j. Chest pain, severe shortness of breath, or occurrence of other safety concerns during the baseline functional tests such as the 400MW test k. History or active signs or symptoms of gallbladder/biliary disease (e.g. previous episodes of cholestasis/biliary tract obstruction, cholelithiasis, cholecystitis, etc.). Of note, history of cholecystectomy and no active biliary signs or symptoms, is not an exclusion criterion. 8. Current physical/rehabilitation therapy (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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To evaluate the safety and efficacy of two doses of BIO101 (175 mg b.i.d. and 350 mg b.i.d.) orally administered for 26 weeks versus placebo in a population of community dwelling older men and women (aged = 65 years) living at home and at risk of mobility disability. 2. To estimate treatment effect on improvement of physical function after a six-month treatment versus placebo in the target population. 3. To estimate treatment effect on reduced risk of mobility disability after a six-month treatment versus placebo in the target population.;Secondary Objective: a. To compare the change from baseline of a standardized patient reported outcome (PRO): the PF-10 sub-score of the SF-36. A minimum clinically significant benefit is set at 2-point difference of the change at M6 from baseline versus placebo in the mean difference between groups. b. To compare the change from baseline to month 6 of the muscle strength using the handgrip strength test. A minimum clinically significant benefit is set at 2 kg difference of the change at M6 from baseline versus placebo in the mean difference between groups;Primary end point(s): Gait speed measured during the 400MW test, the change from baseline to month 6 will be compared between groups of treatment (each dose versus placebo).;Timepoint(s) of evaluation of this end point: during trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PF-10 subscore of the SF-36: the change from baseline to month 6 will be compared between groups of treatment (each dose versus placebo). Muscle strength as measured by the handgrip test: the change from baseline to month 6 will be compared between groups of treatment (each dose versus placebo);Timepoint(s) of evaluation of this end point: during the trial | — |
Countries
Belgium, United States
Contacts
Public ContactWaly Dioh
Biophytis
Outcome results
None listed