Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as 20 hydroxyecdysone (20E)
BIO101 · 2 trials · 6 indications
Knee extension strength will be evaluated by isokinetic dynamometry
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.
| Arm | Type | Description |
|---|---|---|
| BIO101 | EXPERIMENTAL | 4 capsules taken orally twice a day (2 experimental study drug per administration) in the morning and in the evening with the meal approximately at 12-hour distance for 21 weeks. Study Drug Component : 251 mg per capsule including 175 mg of active principle 20E containing also the following compendial excipients: colloidal silica, microcrystalline cellulose and magnesium stearate. |
| Placebo | PLACEBO_COMPARATOR | 4 capsules taken twice a day: two in the morning and two in the evening with the meal approximately at 12-hour distance for 21 weeks. Component : Microcrystalline cellulose, Colloidal anhydrous silica |
| 175mg BIO101 | EXPERIMENTAL | BIO101 was taken orally, two capsules BID, 12 hours apart, up to 9 months. |
| 350mg BIO101 | EXPERIMENTAL | BIO101 was taken orally, two capsules BID, 12 hours apart, up to 9 months. |
| Name | Type | Description |
|---|---|---|
| BIO101 | DRUG | Oral capsules of 175 mg BIO101 containing 20-hydroxyecdysone (20E) at 97% as the active principle |
| Placebo | OTHER | Oral capsules of Placebo |
| Semaglutide | DRUG | Glucagon-like peptide-1 (GLP-1) receptor agonist |
Inclusion Criteria: * 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 s...