The goal of this clinical trial is to learn if BIO101 treatment can improve the muscle strength of participants males and females, aged 18 to 84 years old, suffering from obesity (BMI≥30) or overweight (BMI ≥ 27) with one or more sequelae (e.g., hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease, but excluding diabetes), and treated with semaglutide, a GLP1 agonist for 21 weeks. The main questions it aims to answer are: * Is BIO101 administered orally improving muscle strength, as measured with knee extension strength (using isokinetic dynamometry)? * Is BIO101 administration leading to additional medical problems for patients suffering from obesity or overweight with sequelae and treated with semaglutide? After the end of the study (after last patient did the last visit at the clinic), researchers will compare the BIO101-treated arm to the placebo control arm to see if the candidate drug has an effect on muscle strength, physical function, lean body mass and health related quality of life compared to placebo. BIO101 is the candidate drug and placebo is a look-alike substance that does not contain any active drug Participants will be asked to: * Take 2 pills every morning and every evening of BIO101 or placebo orally for 21 weeks. * Simultaneously, take semaglutide for 21 weeks while being on caloric restriction, following the doctor recommendation and approved prescribing information for semaglutide, with dose increasing up to at least a dose level of 1.7 mg and a maximum dose level of 2.4 mg. * Come to investigational site at screening, baseline, week 6, 13, 21 and week 33 (12 weeks after the end of treatment) for checkups and tests. * Answer to phone calls at week 25 and 29 as well (4 and 8 weeks after the end of treatment) on global health status and quality of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
164
Oral capsules of 175 mg BIO101 containing 20-hydroxyecdysone (20E) at 97% as the active principle
Oral capsules of Placebo
Glucagon-like peptide-1 (GLP-1) receptor agonist
Change from baseline in the knee extension strength at 21 weeks
Knee extension strength will be evaluated by isokinetic dynamometry
Time frame: Baseline and 21 weeks
Change from baseline in the knee flexion strength at 21 weeks
Knee flexion strength will be evaluated by isokinetic dynamometry
Time frame: Baseline and 21 weeks
Change from baseline in handgrip strength at 21 weeks
Handgrip strength will be measured using a Jamar dynamometer handle.
Time frame: baseline and 21 weeks
Change from baseline in the 6-minute walking distance test (6MWD) at 21 weeks
The 6MWD test is measuring the distance a participant can cover within the allotted time of 6 minutes.
Time frame: Baseline and 21 weeks
Change from baseline in Stair Climb Power Test (SCPT) at 21 weeks
The SCPT measures time (in seconds) taken to ascend and descend a flight of stairs (10 steps with a 20 cm step heigh).
Time frame: Baseline and 21 weeks
Change from baseline of five times Sit to Stand Test (5xSST) at 21 weeks
Participants are asked to stand up and sit down 5 times, as quickly as possible. The time to complete this task is recorded.
Time frame: Baseline and 21 weeks
Change from baseline in appendicular and total lean body mass and fat mass at 21 weeks
Body composition will be measured by Dual energy X-ray absorptiometry (DXA).
Time frame: Baseline and 21 weeks
Change from baseline in SF-36 questionnaire at 21 weeks
The Short Form-36 (SF-36) questionnaire measures health-related quality of life.
Time frame: Baseline and 21 weeks
Change from Baseline in WQOL-Lite-CT physical function score
The Weight-Related Quality of Life Lite Clinical Trials (WQOL-Lite-CT) instrument is a validated questionnaire designed to assess the quality of life in individuals with obesity. It contains 21 questions and cover 5 domains: physical function, self-esteem, sexual life, public distress, and work.
Time frame: Baseline and 21 weeks
Change from baseline in body weight at 21 weeks
Body weight will be measured and reported in kg.
Time frame: Baseline and 21 weeks
Change from baseline in BMI at 21 weeks
Height will be measured (m) and agregated to body weight (kg) to report BMI in kg/m².
Time frame: Baseline and 21 weeks
Change from baseline in waist circumference at 21 weeks
Waist circumference will be measured and reported in cm.
Time frame: Baseline and 21 weeks.
Change from baseline in hip circumference at 21 weeks
Hip circumference will be measured and reported in cm.
Time frame: Baseline and 21 weeks.
Change from baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at 21 weeks
HOMA-IR will be derived from fasting plasma glucose level (nmol/L) and fasting plasma insulin level (µU/mL).
Time frame: Baseline ans 21 weeks
Change from baseline in glycated hemoglobin (HbA1c) at 21 weeks
HbA1c will be measured from blood sample and expressed in mmol/mol.
Time frame: Baseline and 21 weeks
Change from baseline in low-density lipoprotein (LDL) cholesterol at 21 weeks
LDL cholesterol will be measured in fasting serum and expressed in mmol/L.
Time frame: Baseline and 21 weeks
Change from baseline in High-Dentsity Lipoprotein (HDL) cholesterol at 21 weeks
HDL cholesterol will be measured in fasting serum and expressed in mmol/L.
Time frame: Baseline and 21 weeks.
Change from baseline in triglycerides at 21 weeks
Triglycerides will be measured in fasting serum and expressed in mmol/l.
Time frame: Baseline and 21 weeks.
Change from baseline in systolic and diastolic pressure (SBP and DBP) at 21 weeks
Blood pressure will be measured using a validated sphygmomanometer; SBP and DBP will be recorded in mmHg.
Time frame: Baseline and 21 weeks.
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