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New pill aims to save your muscles while you shed pounds

NCT ID NCT07411378

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests if an experimental drug called BIO101 can help prevent muscle weakness in people taking the weight-loss drug semaglutide. About 164 obese or overweight adults will take either BIO101 or a placebo pill twice daily for 21 weeks, along with semaglutide and a reduced-calorie diet. Researchers will measure changes in leg strength and overall physical function to see if BIO101 offers added benefit.

Why investors are watching

Biophytis is testing its drug BIO101 in a phase 2 trial to see if it can prevent muscle strength loss in people taking the weight-loss drug semaglutide while dieting. For a micro-cap company with few products, this readout could determine whether it has a viable candidate to address a known side effect of popular GLP-1 drugs.

If it works: If BIO101 shows it preserves muscle strength and lean mass in semaglutide users, Biophytis could position it as a companion treatment for the growing number of people on these weight-loss drugs. That result might attract a larger partner to fund later-stage development.

If it fails: Phase 2 trials often fail to show a clear benefit, and this one has only 164 participants, so the signal may be weak or inconclusive. A negative or muddy result would likely leave Biophytis without a clear path forward and could hurt its ability to raise more money.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 164 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 84 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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. Exclusion Criteria: * 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) * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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How to take part

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  1. The official record

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