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

Completed · Phase 2 · Has a placebo group

Conditions studied: Sarcopenia, Gait Disorders in Old Age, Muscle Weakness

In brief

The main objective of the study is to evaluate the effect of two daily doses of BIO101 versus placebo on mobility function as measured by gait speed using the 400MW test. The absolute change from baseline in meters/second observed in each treatment group at 6 Month was compared to the placebo group. Due to the Covid pandemic \>50% of data at endpoint was missing, which may have affected the ability of the study to deliver the expected results. Additionally, although the planned duration of treatment was 6 months, it was extended up to 9 months for some participants as a result of the pandemic.

Key facts

Study ID

NCT03452488

Run by

Biophytis

People needed

233

Starts

2017-02-07

Expected to finish

2020-04-26

Last updated by the study team

2024-10-01

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged ≥ 65 years and living in the community, reporting loss of physical function over the last 6-12 months
• Short Physical Performance Battery (SPPB) score ≤ 8
• 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
• Ability to take oral medication and be willing to adhere to the study intervention regimen.
• Agreement to adhere to Lifestyle Considerations throughout study duration
• 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 participants.

You may not qualify if…

• 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)
• Non-menopaused women (however ongoing replacement hormonal treatment is not an exclusion criterion)
• Known allergic reactions to components of the investigational drug.
• Treatment with another investigational drug or other intervention within three months
• Unable to understand and perform the functional tests, as judged by the Investigator
• Inability to perform the 400MW test within 15 minutes
• Clinical conditions:
• Current diagnosis of major psychiatric disorders.
• Alcohol abuse or dependence
• Severe arthritis
• Cancer requiring active treatment (cancer treated with chemotherapy, or radiotherapy and currently on remission is not an exclusion criterion)
• Lung disease requiring regular use of supplemental oxygen
• Inflammatory conditions requiring regular use of oral or parenteral corticosteroid agents
• 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)
• Parkinson's disease or other progressive neurological disorder
• Renal disease requiring dialysis, or known renal insufficiency (moderate or severe reduction in GFR≤30 ml/min/1.73 m2)
• Chest pain, severe shortness of breath, or occurrence of other safety concerns during the baseline functional tests 400-meter walk test or 6MWT
• 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.
• 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).

Where it is running

• Advanced Clinical Research — Banning, California, United States
• SC Clinical Research, Inc — Garden Grove, California, United States
• California Research Foundation — San Diego, California, United States
• Institut On Aging — Gainesville, Florida, United States
• Jax-Ascent University of Florida — Jacksonville, Florida, United States
• PANAX Clinical Research — Miami Lakes, Florida, United States
• Clinical Research of Central Florida — Plant City, Florida, United States
• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States
• Jean Mayer USDA Human Nutrition research Center on Aging Tufts University — Boston, Massachusetts, United States
• New Mexico Clinical Research & Osteoporosis Center — Albuquerque, New Mexico, United States
• Columbia University — New York, New York, United States
• PMJ Research of Wilmington — Wilmington, North Carolina, United States
• Bowman Gray Center for Medical Education-of- Wake Forest School of Medicine — Winston-Salem, North Carolina, United States
• Tekton Research — Yukon, Oklahoma, United States
• Tekton Research — Austin, Texas, United States
• Medical Center — Houston, Texas, United States
• Science Advancing Medicine Clinical Research Center — San Antonio, Texas, United States
• The University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
• Advanced Clinical Research — West Jordan, Utah, United States
• Vrije Universiteit Brussel — Brussels, Belgium
• Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg - Centrum voor metabole botziekten — Leuven, Belgium
• Université de Liège — Liège, Belgium

Full record on ClinicalTrials.gov

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