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

• Status: Completed
• Trial end date: 2021-01-20
• Target enrollment: 0
• Participant gender: All

Summary

SARA-INT is a phase 2 interventional study performed in Europe and USA aimed to evaluate the clinical benefits, safety and tolerability of the investigational drug BIO101 administered orally for a six-month (26 weeks) duration to older patients, community dwelling men and women aged ≥65 years, suffering from age-related sarcopenia (including sarcopenic obesity), and at risk of mobility disability.

The double-blind, placebo controlled clinical trial will collect and analyse data on physical performance and body composition and will specifically focus on the change of one functional measurement, the gait speed measured during the 400MW test plus the change of a highly standardised patient reported outcome (PRO), the physical function domain PF-10 at the SF-36 auto-evaluation questionnaire, in order to estimate the efficacy of BIO101 administered over 26 weeks, in preventing mobility disability in the target population.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biophytis

Criteria

Inclusion Criteria:

1. Provision of signed and dated informed consent form

2. Stated willingness to comply with all study procedures and availability for the duration of the study

3. Male or female, aged ≥ 65 years and living in the community, reporting loss of physical function over the last 6-12 months

4. Short Physical Performance Battery (SPPB) score ≤ 8

5. ALM/BMI < 0.789 in men and 0.512 in women, or ALM < 19.75kg in men and <15.02kg in women, as measured by DEXA scan

6. Ability to take oral medication and be willing to adhere to the study intervention regimen.

7. Agreement to adhere to Lifestyle Considerations throughout study duration

8. In the US, women and members of minority groups must be included in accordance with the NIH Policy on Inclusion of Women and Minorities as Participants In Research Involving Human Subjects.

Exclusion Criteria:

1. Current use of anabolic drugs e.g. testosterone; current use of Erythropoietin; current use of corticosteroid agents (except local administration route, like eye drops or dermatologic formulations)

2. Non-menopausal women (however ongoing replacement hormonal treatment is not an exclusion criterion)

3. Known allergic reactions to components of the investigational drug (i.e. stemmacantha carthamoides leaves and roots).

4. Febrile illness within 7 days

5. Treatment with another investigational drug or other intervention within three months

6. Unable to understand and perform the functional tests, as judged by the Investigator

7. Inability to perform the 400MW test within 15 minutes

8. Clinical conditions:

1. Current diagnosis of major psychiatric disorders.

2. Alcohol abuse or dependence

3. Severe arthritis

4. Cancer requiring active treatment (cancer treated with chemotherapy, or radiotherapy and currently on remission is not an exclusion criterion)

5. Lung disease requiring regular use of supplemental oxygen

6. Inflammatory conditions requiring regular use of oral or parenteral corticosteroid agents

7. 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)

8. Parkinson's disease or other progressive neurological disorder

9. Renal disease requiring dialysis, or known renal insufficiency (moderate or severe reduction in GFR≤30 ml/min/1.73 m2)

10. Chest pain, severe shortness of breath, or occurrence of other safety concerns during the baseline functional tests 400-meter walk test or 6MWT

11. 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.

9. 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).