Testing the Efficacy, Safety, and PK of 20E in Patients With Obesity Who Are Starting Treatment With the GLP-1 Agonist Semaglutide for Weight Loss.

Sponsor
Biophytis
Study ID
NCT07411378
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Muscle Wasting
  • Obesity
  • Obesity & Overweight

Eligibility Criteria

Sex
ALL
Age
18 Years - 84 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
Feb 2026
Primary completion
Jun 30, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
164 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BIO101
    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 Comparator: Placebo
    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

Primary Outcome Measure

Change from baseline in the knee extension strength at 21 weeks [ Time Frame: Baseline and 21 weeks ]

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