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.
Willing to participate and able to sign an ICF
BMI ≥30 or BMI ≥27 with one or more weight-associated co-morbidities (e.g. hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease)
Start of treatment with semaglutide for weight loss at Day 3 after the start of the study treatment
Willing to maintain a diet with an average intake of at least 1 gr/kg body weight protein daily
Participant not able to take medications by mouth (as capsules)
Use of disallowed concomitant medications or herbal products: Any herbal products containing 20-hydroxyecdysone and derived from Leuzea carthamoides, Cyanotis vaga, or Cyanotis arachnoidea are not allowed and any other anabolic products, GH/IGF-1 products, spironolactone, metformin, chemotherapeutic agents, antidepressants, and systemic glucocorticoids within three months prior to study enrollment or strong inhibitors of the Organic Anion Transporting Polypeptide (OATP1B3) e.g. rifampicin and cyclosporine. Use of muscle strength-supporting food supplements
Any known hypersensitivity to any of the active substances (20E), and its excipients (the study medication) and the active substance and the excipients of semaglutide.
History or present cholelithiasis or cholecystectomy from medical history or sludge or stones observed on gallbladder ultrasound or any other method.
Parallel
BIO101
DrugOral capsules of 175 mg BIO101 containing 20-hydroxyecdysone (20E) at 97% as the active principle
Placebo
Other interventionOral capsules of Placebo
Semaglutide
DrugGlucagon-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
Change from baseline in the knee flexion strength at 21 weeks
Knee flexion strength will be evaluated by isokinetic dynamometry
Change from baseline in handgrip strength at 21 weeks
Handgrip strength will be measured using a Jamar dynamometer handle.
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.
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).
Maximum Plasma concentration (Cmax) of 20-hydroxyecdysone (20E) and main metabolites when given concomitantly to GLP-1 receptor agonist
Cmax will be derived from plasma concentration of 20E and main metabolites measured at different timepoints and analysed before and after administration of GLP-1 receptor agonist
Time to reach maximum plasma concentration (Tmax) of 20-hydroxyecdysone when given concomitantly to GLP-1 receptor agonist
Tmax will be derived from plasma concentration of 20E measured at different timepoints and analysed before and after administration of GLP-1 receptor agonist
Area under the plasma concentration-time curve from Time zero to last quantifiable concentration (AUC0-t) of 20-hydroxyecdysone when given concomitantly to GLP-1 receptor agonist
AUC0-t will be derived from plasma concentration of 20E measured at different timepoints and analysed before and after administration of GLP-1 receptor agonist.
Elimination half-life (t1/2) of 20-hydroxyecdysone when given concomitantly to GLP-1 receptor agonist
t1/2 will be derived from plasma concentration of 20E measured at different timepoints and analysed before and after administration of GLP-1 receptor agonist.
This trial is not recruiting at the moment. You can still explore other options:
