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

NCT03452488 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: BIO101-CL03
• Study Type: interventional
• Target: 233
• Locations: 2 countries
• Sites: 22

Brief Summary

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.

Conditions

Sarcopenia; Gait Disorders in Old Age; Muscle Weakness

Keywords

Sarcopenia; Sarcopenic Obesity; 6-minute walking distance; 400 meters walking test; BIO101; Short Physical Performance Battery; Appendicular lean mass

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to 6 Months in Gait Speed for 400 Meter Walking (MW) Test

  Gait speed was measured using the 400 MW test, which measured how long it took the participant to walk a distance of 400 meters. Missing data imputed using adjusted Bayesian Multiple Imputation (MI) methods for Non-Completers who failed to perform the Test feasibility and Multiple Imputation for participants who without data on on-Site visit. Data up to 9 months was used where 6 months data were unavailable for participants enrolled during the COVID-19 pandemic.

  Baseline and 6 Months

Secondary Outcomes (11)

• Change From Baseline to 6 Months in Short Form-36 (SF-36) 10 Item Physical Function Domain (PF-10) Sub-score

  Baseline and 6 Months

• Change From Baseline to 6 Months in Handgrip Strength Test

  Baseline and 6 Months

• Change From Baseline to 6 Months in Appendicular Lean Body Mass (ALM) Based on Dual-energy X-ray Absorptiometry (DEXA) Measurements

  Baseline and 6 Months

• Rate of Response for Completing 400 MW Test After 6 Months

  Baseline and 6 Months

• Change From Baseline to 6 Months in Muscle Strength Based on Knee Extension

  Baseline and 6 Months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo was taken orally, two capsules twice daily (BID), 12 hours apart, up to 9 months.

Drug: Placebo

175mg BIO101

EXPERIMENTAL

BIO101 was taken orally, two capsules BID, 12 hours apart, up to 9 months.

Drug: BIO101

350mg BIO101

EXPERIMENTAL

BIO101 was taken orally, two capsules BID, 12 hours apart, up to 9 months.

Drug: BIO101

Interventions

BIO101 DRUG

Oral capsules

Also known as: 20 hydroxyecdysone (20E)

175mg BIO101; 350mg BIO101

Placebo DRUG

Oral capsules

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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

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)
• 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
• 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

Sponsors & Collaborators

• Biophytis: lead

Study Sites (22)

Advanced Clinical Research

Banning, California, 92221, United States

Location

SC Clinical Research, Inc

Garden Grove, California, 92844, United States

Location

California Research Foundation

San Diego, California, 92123, United States

Location

Institut On Aging

Gainesville, Florida, 32611, United States

Location

Jax-Ascent University of Florida

Jacksonville, Florida, 32209, United States

Location

PANAX Clinical Research

Miami Lakes, Florida, 33014, United States

Location

Clinical Research of Central Florida

Plant City, Florida, 33563, United States

Location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Jean Mayer USDA Human Nutrition research Center on Aging Tufts University

Boston, Massachusetts, 02111, United States

Location

New Mexico Clinical Research & Osteoporosis Center

Albuquerque, New Mexico, 87106, United States

Location

Columbia University

New York, New York, 10032, United States

Location

PMJ Research of Wilmington

Wilmington, North Carolina, 28401, United States

Location

Bowman Gray Center for Medical Education-of- Wake Forest School of Medicine

Winston-Salem, North Carolina, 27101, United States

Location

Tekton Research

Yukon, Oklahoma, 73099, United States

Location

Tekton Research

Austin, Texas, 78745, United States

Location

Medical Center

Houston, Texas, 77030, United States

Location

Science Advancing Medicine Clinical Research Center

San Antonio, Texas, 78229, United States

Location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78245, United States

Location

Advanced Clinical Research

West Jordan, Utah, 84088, United States

Location

Vrije Universiteit Brussel

Brussels, 1090, Belgium

Location

Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg - Centrum voor metabole botziekten

Leuven, 3000, Belgium

Location

Université de Liège

Liège, 4020, Belgium

Location

MeSH Terms

Conditions

Sarcopenia; Muscle Weakness

Interventions

Ecdysterone

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Ecdysteroids; Cholestenones; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Insect Hormones; Invertebrate Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Limitations and Caveats

Due to the coronavirus disease 2019 (COVID-19) outbreak, the implementation of the clinical protocol was affected, including but not limited to the scheduled site visit for safety and/or efficacy, site visits for monitoring, investigational product delivery, collection of adverse events (AEs) and concomitant medications. This led to \>50% loss of efficacy data for the primary endpoint and other performance assessments.

Results Point of Contact

• Title: Cendrine Tourette
• Organization: Biophytis S.A.

cendrine.tourette@biophytis.com

+331 44 27 33 00

Study Officials

• Rob Van Maanen

  Biophytis

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Each treatment kit showed a preprinted kit number affixed on the primary, secondary and tertiary container. The kit number was assigned via the eCRF after a participant is qualified and was randomized. Neither the Investigator and his staff, nor the Sponsor was aware of the treatment that corresponds to the kit number. The assigned treatment cannot be retrieved from the system, unless a specific unblinding procedure was engaged by the investigator when this was judged necessary by the responsible physician of the investigator center in the context of a severe or serious adverse event.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: March 2, 2018
• Study Start: February 7, 2017
• Primary Completion: April 26, 2020
• Study Completion: April 26, 2020
• Last Updated: October 1, 2024
• Results First Posted: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3); US (19)