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Phase 1

• Conditions: Sarcopenia including sarcopenic obesity; MedDRA version: 20.1Level: PTClassification code 10063024Term: SarcopeniaSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2017-003932-35-BE
• Lead Sponsor: Biophytis S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-02
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 231

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 < 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 (see section 6)
7. Agreement to adhere to the outlined Lifestyle Considerations
(see section 5.4) throughout the study duration
8. In the US, women and members of minority groups should not
be excluded, in accordance with the NIH Policy on Inclusion of
Women and Minorities as Participants In Research Involving
Human Subjects.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 231

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified