Muscle WastingPhase 2OBANCT07411378
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 study testing BIO101 and Semaglutide in people with Muscle Wasting and Obesity & Overweight, run by Biophytis.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Muscle Wasting, Obesity & Overweight, Obesity
- What is being tested?
- BIO101 and Semaglutide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Willing to maintain sufficient exercise, i.e. at least 150 minutes per week moderate-vigorous exercise
- Body weight stable (within a 5 kg range) in the 3 months prior to enrolment
- Female participants should be at least 12 months post-menopausal) or surgically sterile OR have a negative urine pregnancy test at screening and be willing to use a contraceptive method from screening to 90 days after last dose.
- Based on Semaglutide long half-life, participants should consent to use a contraception method 3 months after administration of the last dose intake of semaglutide.
Who cannot join
- 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.
- Presence of contra-indications to semaglutide per current semaglutide Prescribing Information / Summary of Product Characteristics
- Current diabetes (both insulin dependent and T2DM)
Show all 28Show fewer
- A history of chronic pancreatitis or acute pancreatitis
- Previous surgical obesity treatment or planned obesity surgery during the study period
- Use of anti-obesity (weight-loss) medication or use of any GLP-1 RA for diabetes within 90 days before enrollment
- BMI >40
- Uncontrolled hypertension (RR above 150/100 mmHg)
- NYHA Class III or IV CHF
- History of stroke, myocardial infarction, life-threatening arrhythmia, or coronary revascularization within 6 months prior to screening
- Clinically significant liver disease, ALT/AST >5x ULN, or total bilirubin > 2x ULN, unless the patient has known Gilbert's syndrome
- Neuromuscular disorder or CK >5x ULN
- Autoimmune/inflammatory disorders that may cause muscle wasting
- Use of antipsychotics, amphetamines, or any other treatments that can affect weight
- Clinically significant ECG abnormalities
- History of major depressive disorder within the last 2 years
- Any lifetime history of suicide attempt
- History of any suicidal behavior in the last month
- History of other severe psychiatric disorders, e.g., schizophrenia, bipolar disorder
- Baseline PHQ-9 score ≥15 or any suicidal ideation of level 4 or level 5 on the Columbia-Suicide Severity Rating Scale
- History or current gastroparesis (from medical history)
- Patients with obesity due to other endocrinologic disorders
- eGFR ≤60 mL/min/1.73 m2, based on Cockcroft \& Gault formula OR Participant requiring renal dialysis
- Patients with clinically Recognized Eating Disorders
- Patients with clinically significant, uncontrolled hyperthyroidism or hypothyroidism, or those with newly diagnosed thyroid disease within the past 3 months.
About this study
Official title: 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).
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
Read more
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
- Being tested
- BIO101, Placebo, Semaglutide
- Keywords
- obesity, overweight, muscle, strength, physical performance
- Medical subject headings
- Muscular Atrophy, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIO101Drug
Oral capsules of 175 mg BIO101 containing 20-hydroxyecdysone (20E) at 97% as the active principle
PlaceboOther
Oral capsules of Placebo
SemaglutideDrug
Also called Wegovy, Ozempic
Glucagon-like peptide-1 (GLP-1) receptor agonist
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: BIO101; Drug: Semaglutide |
| 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 Receives: Other: Placebo; Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the knee extension strength at 21 weeks
Knee extension strength will be evaluated by isokinetic dynamometry
Measured: Baseline and 21 weeks
Secondary outcomes (18)
Change from baseline in the knee flexion strength at 21 weeks
Knee flexion strength will be evaluated by isokinetic dynamometry
Measured: Baseline and 21 weeks
Change from baseline in handgrip strength at 21 weeks
Handgrip strength will be measured using a Jamar dynamometer handle.
Measured: baseline and 21 weeks
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.
Measured: Baseline and 21 weeks
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).
Measured: Baseline and 21 weeks
Change from baseline of five times Sit to Stand Test (5xSST) at 21 weeks
Participants are asked to stand up and sit down 5 times, as quickly as possible. The time to complete this task is recorded.
Measured: Baseline and 21 weeks
Change from baseline in appendicular and total lean body mass and fat mass at 21 weeks
Body composition will be measured by Dual energy X-ray absorptiometry (DXA).
Measured: Baseline and 21 weeks
Change from baseline in SF-36 questionnaire at 21 weeks
The Short Form-36 (SF-36) questionnaire measures health-related quality of life.
Measured: Baseline and 21 weeks
Change from Baseline in WQOL-Lite-CT physical function score
The Weight-Related Quality of Life Lite Clinical Trials (WQOL-Lite-CT) instrument is a validated questionnaire designed to assess the quality of life in individuals with obesity. It contains 21 questions and cover 5 domains: physical function, self-esteem, sexual life, public distress, and work.
Measured: Baseline and 21 weeks
Change from baseline in body weight at 21 weeks
Body weight will be measured and reported in kg.
Measured: Baseline and 21 weeks
Change from baseline in BMI at 21 weeks
Height will be measured (m) and agregated to body weight (kg) to report BMI in kg/m².
Measured: Baseline and 21 weeks
Change from baseline in waist circumference at 21 weeks
Waist circumference will be measured and reported in cm.
Measured: Baseline and 21 weeks.
Change from baseline in hip circumference at 21 weeks
Hip circumference will be measured and reported in cm.
Measured: Baseline and 21 weeks.
Change from baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at 21 weeks
HOMA-IR will be derived from fasting plasma glucose level (nmol/L) and fasting plasma insulin level (µU/mL).
Measured: Baseline ans 21 weeks
Change from baseline in glycated hemoglobin (HbA1c) at 21 weeks
HbA1c will be measured from blood sample and expressed in mmol/mol.
Measured: Baseline and 21 weeks
Change from baseline in low-density lipoprotein (LDL) cholesterol at 21 weeks
LDL cholesterol will be measured in fasting serum and expressed in mmol/L.
Measured: Baseline and 21 weeks
Change from baseline in High-Dentsity Lipoprotein (HDL) cholesterol at 21 weeks
HDL cholesterol will be measured in fasting serum and expressed in mmol/L.
Measured: Baseline and 21 weeks.
Change from baseline in triglycerides at 21 weeks
Triglycerides will be measured in fasting serum and expressed in mmol/l.
Measured: Baseline and 21 weeks.
Change from baseline in systolic and diastolic pressure (SBP and DBP) at 21 weeks
Blood pressure will be measured using a validated sphygmomanometer; SBP and DBP will be recorded in mmHg.
Measured: Baseline and 21 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study startJul 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WastingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biophytis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411378
- Sponsor's protocol ID
- BIO101-CL10
- Acronym
- OBA
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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).
- ClinicalTrials.gov ID
- NCT07411378
- Acronym / sponsor ID
- OBA / BIO101-CL10
- Conditions
- Muscle Wasting, Obesity & Overweight, Obesity
- Keywords
- obesity, overweight, muscle, strength, physical performance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- BiophytisIndustry (pharma, biotech, devices)
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIO101 | Experimental | Drug: BIO101, Drug: Semaglutide4 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 | Other: Placebo, Drug: Semaglutide4 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 |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- Willing to maintain sufficient exercise, i.e. at least 150 minutes per week moderate-vigorous exercise
Key exclusion criteria (28 listed)
- 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.
- Presence of contra-indications to semaglutide per current semaglutide Prescribing Information / Summary of Product Characteristics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIO101Oral capsules of 175 mg BIO101 containing 20-hydroxyecdysone (20E) at 97% as the active principle | Drug | BIO101 |
| PlaceboOral capsules of Placebo | Other | Placebo |
| SemaglutideAlso: Wegovy, OzempicGlucagon-like peptide-1 (GLP-1) receptor agonist | Drug | BIO101, Placebo |
Primary outcome
Change from baseline in the knee extension strength at 21 weeks
Time frame: Baseline and 21 weeks
Knee extension strength will be evaluated by isokinetic dynamometry
18 secondary outcomes
Change from baseline in the knee flexion strength at 21 weeks
Time frame: Baseline and 21 weeks
Change from baseline in handgrip strength at 21 weeks
Time frame: baseline and 21 weeks
Change from baseline in the 6-minute walking distance test (6MWD) at 21 weeks
Time frame: Baseline and 21 weeks
Change from baseline in Stair Climb Power Test (SCPT) at 21 weeks
Time frame: Baseline and 21 weeks
Change from baseline of five times Sit to Stand Test (5xSST) at 21 weeks
Time frame: Baseline and 21 weeks
Change from baseline in appendicular and total lean body mass and fat mass at 21 weeks
Time frame: Baseline and 21 weeks
Change from baseline in SF-36 questionnaire at 21 weeks
Time frame: Baseline and 21 weeks
Change from Baseline in WQOL-Lite-CT physical function score
Time frame: Baseline and 21 weeks
Change from baseline in body weight at 21 weeks
Time frame: Baseline and 21 weeks
Change from baseline in BMI at 21 weeks
Time frame: Baseline and 21 weeks
Change from baseline in waist circumference at 21 weeks
Time frame: Baseline and 21 weeks.
Change from baseline in hip circumference at 21 weeks
Time frame: Baseline and 21 weeks.
Change from baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at 21 weeks
Time frame: Baseline ans 21 weeks
Change from baseline in glycated hemoglobin (HbA1c) at 21 weeks
Time frame: Baseline and 21 weeks
Change from baseline in low-density lipoprotein (LDL) cholesterol at 21 weeks
Time frame: Baseline and 21 weeks
Change from baseline in High-Dentsity Lipoprotein (HDL) cholesterol at 21 weeks
Time frame: Baseline and 21 weeks.
Change from baseline in triglycerides at 21 weeks
Time frame: Baseline and 21 weeks.
Change from baseline in systolic and diastolic pressure (SBP and DBP) at 21 weeks
Time frame: Baseline and 21 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BIO101 and Semaglutide in people with Muscle Wasting and Obesity & Overweight, run by Biophytis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the knee extension strength at 21 weeks (time frame: Baseline and 21 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.