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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.

NCT07411378 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2026-02-13

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Biophytis

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-06-30
Completion
2027-08-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07411378 on ClinicalTrials.gov