Evaluation of BP1.4979 in Female Patients with Moderate to Severe Binge Eating Disorder: A Double-Blind, Placebo-Controlled Pilot Study
- Trial ID
- 2023-506511-17-00
- Protocol
- P20-08 / BP1.4979
- Sponsor
- Bioprojet Pharma
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this double-blind, placebo-controlled pilot trial is to evaluate the **efficacy** and **safety** of BP1.4979, administered at a dosage of 15 mg twice daily, in female patients diagnosed with moderate to severe **binge eating disorder** (BED). This assessment is clinically relevant as it aims to determine the potential therapeutic benefits and safety profile of BP1.4979, which could offer a new treatment option for individuals suffering from BED, a condition characterized by recurrent episodes of eating large quantities of food, often quickly and to the point of discomfort.
Participants
The clinical trial focuses on assessing the efficacy and safety of BP1.4979 15 mg BID in **female** patients diagnosed with moderate to severe **binge eating disorder** (BED). The study population consists exclusively of females aged between 18 and 65 years, with a diagnosis of BED according to DSM-5 criteria. Participants are required to have experienced at least two binge-eating days per week and a minimum of eight episodes during the two weeks prior to the initiation of study medication, as documented in take-home binge diaries. The trial includes individuals with a body mass index (BMI) of less than 50 kg/m². The sponsor has not provided information regarding the total number of participants. The selection process ensures that participants have adequate support to comply with the study requirements, including transportation, understanding of self-rating scales, drug compliance, and availability for scheduled visits. The trial does not include male subjects, and the population is considered vulnerable. Lifestyle considerations such as diet and physical activity are not specified in the provided data.
Plans and Procedures
The clinical trial is designed to evaluate the **efficacy** and safety of BP1.4979, a chemical compound, in female patients diagnosed with moderate to severe **binge eating disorder** (BED). This study is a randomized, double-blind, placebo-controlled trial, which ensures that neither the participants nor the investigators know who is receiving the active treatment or the placebo, thereby minimizing bias. The trial is set to last for a total of 8 weeks, with the primary endpoint being the change in the total number of binge-eating episodes per week, as recorded in self-reported binge-eating diaries, from baseline to the end of the treatment period.
Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as age, diagnosis according to DSM-5 criteria, and body mass index (BMI). Following successful screening, participants will be randomized to receive either BP1.4979 or a matching placebo tablet, administered orally. The study includes regular follow-up visits to monitor safety and efficacy, with assessments such as the Continuous Glucose Monitoring System (CGMS) to evaluate dietary intake patterns, and changes in the Yale Food Addiction Scale (YFAS) and Clinical Global Impression (CGI) scales from baseline to Week 8.
The expected length of participant involvement is approximately 8 weeks, with conditions for early termination including adverse events, withdrawal of consent, or non-compliance with study procedures. The end-of-study visit will involve a final assessment of the primary and secondary endpoints, ensuring comprehensive data collection for analysis. The trial aims to provide valuable insights into the potential benefits of BP1.4979 for individuals with BED, contributing to the broader understanding of treatment options for this condition.
Treatment
The clinical trial involves the administration of the experimental medication **BP1.4979**, which is chemically known as **N-[4-[2-[4-(3-cyanophenyl)piperazin-1-yl]ethyl]cyclohexyl]-3-methoxypropanamide**. This medication is provided in the form of a **tablet** and is intended for **oral use**. The dosage regimen for BP1.4979 is 15 mg administered twice daily (BID), with a maximum daily dose of 30 mg. The total maximum dose over the treatment period is 1680 mg. The treatment duration is set for a maximum of 8 weeks. The medication is produced by BIOPROJET and is not a paediatric formulation. Compliance with the dosing schedule will be monitored throughout the study to ensure adherence to the protocol.
In addition to the experimental medication, the study includes a **matching film-coated placebo tablet**. The placebo is designed to be indistinguishable from the active medication in appearance and is used to maintain the double-blind nature of the trial. The placebo does not contain any active pharmaceutical ingredients and serves as a control to evaluate the efficacy and safety of BP1.4979 in treating moderate to severe **binge eating disorder**. Participants will receive either the active medication or the placebo according to the randomization schedule, and compliance will be similarly monitored to ensure accurate assessment of the treatment outcomes.
Efficacy
The efficacy of BP1.4979 in the treatment of **binge eating disorder** (BED) will be assessed through a double-blind, placebo-controlled pilot trial. The primary efficacy endpoint is the change in the total number of binge-eating episodes per week, as recorded in self-reported binge-eating diaries. This change will be measured from a 2-week baseline period (Day -14 to Day 0) to the last 2 weeks of the treatment period (Day 43 to Day 56).
Secondary efficacy endpoints include several measures: the use of a Continuous Glucose Monitoring System (CGMS) to assess the number of dietary intakes identified as binge-eating episodes, changes in the Yale Food Addiction Scale (YFAS) from baseline to Week 8, and changes in the Clinical Global Impression (CGI) scale, specifically CGI-Severity (CGI-S) and CGI-Improvement (CGI-I), from baseline to Week 8. Additionally, the change in the number of binge-eating days per week will be evaluated from baseline to Week 7 and Week 8.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Patient must voluntarily express a willingness to participate in this study, sign and date an informed consent prior to beginning any protocol required procedures.
- Female aged between 18 and 65 years, inclusive.
- Diagnosis of BED according to DSM-5 criteria.
- At least two binge-eating days per week and at least 8 episodes during the 2 weeks prior to initiation of study medication, prospectively documented in take-home binge diaries.
- BMI < 50 kg/m2.
- In the opinion of the investigator, the patient has adequate support to comply with the entire study requirements as described in the protocol (e.g.,transportation to and from trial site, ability to understand and fill in the self-rating scales, drug compliance, availability to attend to the scheduled visits, full understanding of the protocol etc..).
Exclusion Criteria
- Patient with a current diagnosis of bulimia nervosa or anorexia nervosa.
- History of bariatric surgery in the past 5 years before study entry.
- Clinically unstable and concomitant medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine, or other systemic disease.
- Concomitant prolactin-dependent tumors (e.g., pituitary gland prolactinomas or breast cancer).
- Severe hepatic impairment or liver function tests (AST, ALT) > 3 ULN, renal impairment, or abnormal clinical laboratory results (in most cases > 3 ULN) specifically including hypokalemia.
- Suicidal ideation as evidenced by positive answer to questions 4 or 5 in the Columbia-Suicide-Severity Rating Scale (C-SSRS) at screening or suicide risk as per BDI-13 (item G > 0).
- Psychological (e.g., supportive psychotherapy, cognitive behavior therapy, interpersonal therapy) or weight loss (e.g., Weight Watchers) intervention for BED that was begun within the 3 months before study entry. Patients on such treatment for more than 3 months prior to screening may be enrolled if they agree not to make any changes to the frequency or nature of their treatment during the course of the study.
- History of suspected substance abuse or dependence (except nicotine abuse or dependence) within the 6 months prior to screening or positive drug test at screening.
- Regular cannabis consumption.
- Use of psychostimulants to facilitate fasting or dieting as a part of the eating disorder within the past 6 months, misuse of psychostimulants within the past 6 months, or positive drug screen for psychostimulants at the screening visit.
- History (within the past year) of psychosis, severe mania or hypomania, or dementia or any other active clinically significant illness or any psychiatric disorder that might interfere with a diagnostic assessment, treatment, or study compliance.
- Ongoing alcohol or tobacco addiction treatment (except Nicotine Replacement Therapy [NRT] with at least one-month stable dose prior to screening visit).
- Patient who is pregnant, lactating, or of childbearing potential who is not using adequate contraceptive measures. The following are considered adequate methods of birth control: 1. intrauterine device (IUD); 2. contraceptive implantation system; 3. oral contraceptive pills; 4. surgically sterile patient; and 5. abstinence. Women are considered not to have childbearing potential before their menarche, at least 2 years after menopause (no menses) or if they have had a permanent sterilization that includes hysterectomy, bilateral salpingectomy and bilateral oophorectomy. All participants should have a negative pregnancy test prior to randomization. Birth control methods must be in place for the total duration of the study and until the end of exposure to the study treatment (i.e., 5 half-lives of the study drug corresponding to 4 days after last dose of BP1.4979).
- Uncontrolled hypertension (>160/100 mmHg).
- Known history of long QTc syndrome or presenting on ECG: - a QTcF interval strictly higher than 450 ms (electrocardiogram Fridericia’s corrected QT interval = QT / 3√ [60/HR]), - or any significant abnormality (e.g., within the last 3 months prior to screening: myocardial infarction, significant arrhythmias or conduction abnormalities) which in the opinion of the physician investigator precludes study participation.
- Prior (within 30 days or 5 half-lives prior to screening visit, whichever is longer) or current therapy with any psychotropic medications including monoamine oxidase inhibitors (MAOIs) antidepressants, antipsychotics, antiepileptics, dopamine antagonist antiemetics, dopamine agonists, mood stabilizers, or psychostimulants, GLP-1 receptor agonists, long-acting benzodiazepines and therapy with herbal preparations and over-the-counter medications.
- Known hypersensitivity to the tested treatment including active substance and excipients.
- Participation in clinical trial and receipt of investigational drug(s) during previous 60 days (or 5 half-lives, whichever is longer), except as explicitly approved by the Principal Investigator.
- No health insurance.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 France | Not Recruiting | 07 Mar 2022 | 66 |
 Spain | Not Recruiting | 07 Mar 2022 | 20 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
Matching film-coated placebo tablet | Placebo | N/A | — | — | — | N/A |