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Study on BP1.4979 for Treating Binge Eating Disorder in Women with Moderate to Severe Symptoms

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as binge eating disorder, which involves regularly eating large amounts of food in a short period while feeling a lack of control over eating. The trial is testing a new treatment called BP1.4979, which is taken as a tablet. The purpose of the study is to evaluate how effective and safe this medication is for women with moderate to severe binge eating disorder.

Participants in the study will be given either the medication BP1.4979 or a matching film-coated placebo tablet. The study is designed to be "double-blind," meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not influenced by expectations about the treatment. The study will last for a period of eight weeks, during which participants will take the medication twice a day.

Throughout the study, participants will keep a diary to record their binge eating episodes. The main goal is to see if there is a change in the number of binge eating episodes per week from the start to the end of the study. Additionally, other aspects such as changes in dietary habits and overall impressions of improvement will be monitored. This trial aims to provide valuable information on whether BP1.4979 can be a helpful treatment for those struggling with binge eating disorder.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of binge eating disorder and ensuring the patient meets all inclusion criteria, such as age and frequency of binge-eating episodes.

  2. Step 2

    Baseline period

    A baseline period of 2 weeks is established, during which the patient documents binge-eating episodes in a diary. This period helps to establish a reference point for the study.

  3. Step 3

    Medication administration

    The patient begins taking the study medication, BP1.4979, at a dosage of 15 mg twice daily (BID). The medication is administered orally in the form of a tablet.

    A placebo, which is a tablet with no active ingredients, may also be administered to some patients as part of the study's double-blind design.

  4. Step 4

    Treatment period

    The treatment period lasts for 8 weeks. During this time, the patient continues to take the medication as prescribed and records any binge-eating episodes in a diary.

    The primary goal is to observe changes in the number of binge-eating episodes per week.

  5. Step 5

    Monitoring and assessments

    Throughout the study, various assessments are conducted to monitor the patient's progress. These include the use of a Continuous Glucose Monitoring System (CGMS) to track dietary intake patterns.

    Additional assessments involve the Yale Food Addiction Scale (YFAS) and the Clinical Global Impression (CGI) scale to evaluate changes in food addiction symptoms and overall clinical status.

  6. Step 6

    End of treatment evaluation

    At the end of the 8-week treatment period, a final evaluation is conducted. This includes comparing the number of binge-eating episodes recorded during the baseline period with those recorded in the last 2 weeks of treatment.

    The study aims to determine the efficacy and safety of the medication in reducing binge-eating episodes.

Who can join the trial?

6 criteria

  • The patient must willingly agree to take part in the study and sign a consent form before starting any study-related activities.
  • The patient must be a female between the ages of 18 and 65.
  • The patient must have a diagnosis of Binge Eating Disorder (BED) according to the DSM-5 criteria. The DSM-5 is a guide used by doctors to diagnose mental health conditions.
  • The patient must have at least two days of binge eating per week and at least 8 episodes in the two weeks before starting the study medication. This should be recorded in a binge diary that the patient keeps at home.
  • The patient must have a Body Mass Index (BMI) of less than 50 kg/m². BMI is a number calculated from a person's weight and height to see if they are in a healthy weight range.
  • The patient must have enough support, in the opinion of the study doctor, to follow all the study requirements. This includes being able to travel to the study site, understanding and completing self-rating scales, taking the study medication as instructed, attending scheduled visits, and fully understanding the study details.

Who cannot join the trial?

4 criteria

  • Patients who are not female cannot participate.
  • Patients who do not have a diagnosis of binge eating disorder cannot participate. Binge eating disorder is a condition where a person frequently eats large amounts of food and feels unable to stop.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined by the study, but it is not specified here.
  • Patients who are considered part of a vulnerable population may not be eligible. Vulnerable populations can include groups like children, pregnant women, or those with certain disabilities.
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Investigated drugs

BP1.4979 is a medication being studied for its potential to help treat binge eating disorder. This trial aims to evaluate how effective and safe BP1.4979 is for women who have moderate to severe symptoms of this condition. The medication is being tested to see if it can reduce the frequency and severity of binge eating episodes.

What is already known about the treatment

BP1.4979 – This medication is administered orally in the form of tablets, taken twice daily. It is currently being studied in clinical trials for its potential use in treating binge eating disorder, with a focus on its effectiveness and safety in female patients. The main therapeutic indication for BP1.4979 is to help manage symptoms of binge eating disorder. At the molecular level, BP1.4979 is believed to work by modulating neurotransmitter activity in the brain, which may help reduce the frequency and intensity of binge eating episodes. It is classified pharmacologically as a central nervous system agent.

Investigated diseases

Binge Eating Disorder – Binge eating disorder is characterized by recurrent episodes of eating large quantities of food, often quickly and to the point of discomfort. Individuals with this disorder may feel a lack of control during these episodes and experience feelings of shame or guilt afterward. Unlike other eating disorders, binge eating is not followed by purging behaviors such as vomiting or excessive exercise. The disorder can lead to weight gain and associated health issues over time. It often involves emotional distress and can affect a person's social and professional life. The frequency and severity of binge eating episodes can vary among individuals.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506511-17-00Protocol codeP20-08 / BP1.4979Estimated enrolment86 patientsSponsorBioprojet Pharma

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).