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

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Hopitaux Universitaires Pitie Salpetriere Paris France
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital Universitario Dr Peset Aleixandre Valencia Spain
Cflw Di Nmvej Vandoeuvre Les Nancy France
Crj Drtef Byelbcmgi Hxyfjdp Frvozyjb Mrumkoaam Dijon France
Haczdglc Ukboiicrlhdor Hcaebklq Tvxrt y Ptasyx Ifzvwrjl Ctnkwz dbfemwnloegdackrv (oils Badalona Spain
Hcvsoxvu Vkar dwikoffw Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
07.03.2022
Spain Spain
Not recruiting
07.03.2022

Trial locations

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.

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 ID:
2023-506511-17-00
Protocol code:
P20-08 / BP1.4979
NCT ID:
NCT05118906
Trial Phase:
Therapeutic exploratory (Phase II)

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