NCT07411378

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.

A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of 20-hydroxyecdysone (20E) in Reducing the Muscle Strength Loss From the GLP1 Agonist Semaglutide in Combination With Dieting in Obese and Overweight Adult Patients (OBA).

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 164 (estimated)
• Sponsor: Biophytis · Industry
• Sex: All
• Age: 18 Years – 84 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Muscle Wasting
• Obesity & Overweight
• Obesity

Interventions

Type	Name	Description
DRUG	BIO101	Oral capsules of 175 mg BIO101 containing 20-hydroxyecdysone (20E) at 97% as the active principle
OTHER	Placebo	Oral capsules of Placebo
DRUG	Semaglutide	Glucagon-like peptide-1 (GLP-1) receptor agonist

Timeline

• Start date: 2026-07-01
• Primary completion: 2027-06-01
• Completion: 2027-08-01
• First posted: 2026-02-13
• Last updated: 2026-02-13

Regulatory

• FDA-regulated drug study