A Double-blind, Placebo-controlled, Randomized INTerventional Clinical Trial (SARA-INT)
Public ClinicalTrials.gov record NCT03452488. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Safety and Efficacy of BIO-101 175 mg b.i.d. and 350 mg b.i.d. 26-week Oral Administration to Patients Suffering From Age-related SARcopenia, Including Sarcopenic Obesity, Aged ≥65 Years and at Risk of Mobility Disability
Study identification
- NCT ID
- NCT03452488
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Biophytis
- Industry
- Enrollment
- 233 participants
Conditions and interventions
Conditions
Interventions
- BIO101 Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 65 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 6, 2017
- Primary completion
- Apr 25, 2020
- Completion
- Apr 25, 2020
- Last update posted
- Sep 30, 2024
2017 – 2020
United States locations
- U.S. sites
- 19
- U.S. states
- 10
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Advanced Clinical Research | Banning | California | 92221 | — |
| SC Clinical Research, Inc | Garden Grove | California | 92844 | — |
| California Research Foundation | San Diego | California | 92123 | — |
| Institut On Aging | Gainesville | Florida | 32611 | — |
| Jax-Ascent University of Florida | Jacksonville | Florida | 32209 | — |
| PANAX Clinical Research | Miami Lakes | Florida | 33014 | — |
| Clinical Research of Central Florida | Plant City | Florida | 33563 | — |
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | — |
| Jean Mayer USDA Human Nutrition research Center on Aging Tufts University | Boston | Massachusetts | 02111 | — |
| New Mexico Clinical Research & Osteoporosis Center | Albuquerque | New Mexico | 87106 | — |
| Columbia University | New York | New York | 10032 | — |
| PMJ Research of Wilmington | Wilmington | North Carolina | 28401 | — |
| Bowman Gray Center for Medical Education-of- Wake Forest School of Medicine | Winston-Salem | North Carolina | 27101 | — |
| Tekton Research | Yukon | Oklahoma | 73099 | — |
| Tekton Research | Austin | Texas | 78745 | — |
| Medical Center | Houston | Texas | 77030 | — |
| Science Advancing Medicine Clinical Research Center | San Antonio | Texas | 78229 | — |
| The University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78245 | — |
| Advanced Clinical Research | West Jordan | Utah | 84088 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03452488, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 30, 2024 · Synced Jul 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03452488 live on ClinicalTrials.gov.