A double-blind, placebo-controlled pilot trial of BP1.4979 for the treatment of binge eating disorder

Phase 1

Conditions: Binge eating disorder (BED)
MedDRA version: 24.0Level: PTClassification code 10004716Term: Binge eatingSystem Organ Class: 10037175 - Psychiatric disorders
Therapeutic area: Psychiatry and Psychology [F] - Behaviours [F01]

Registration Number: EUCTR2021-000472-11-FR

Lead Sponsor: BIOPROJET PHARMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 66

Inclusion Criteria

1.Patient must voluntarily express a willingness to participate in this study, sign and date an informed consent prior to beginning any protocol required procedures.
2.Female aged between 18 and 65 years, inclusive.
3.Diagnosis of BED according to DSM-5 criteria. These criteria are:
a.Recurrent episodes of binge eating. Both of the following characterize a binge-eating episode: 1. Eating, in a discrete period of time (e.g., within any 2-hour period), an amount of food that is definitely larger than what most people would eat in a similar period of time under similar conditions; and 2. A sense of lack of control over the eating during the episode (e.g., a feeling that one cannot stop eating or control what or how much one is eating).
b.The binge-eating episodes are associated with at least three of the following: eating much more rapidly than normal; eating until uncomfortably full; eating large amounts of food when not feeling physically hungry; eating alone because of being embarrassed by how much one is eating; feeling disgusted with oneself, depressed, or feeling very guilty after overeating.
c.Marked distress regarding binge eating.
d.The binge eating occurs, on average, at least once a week for 3 months.
e.The episodes of binge eating do not occur exclusively during the course of bulimia nervosa or anorexia nervosa.
4.At least two binge-eating days per week with at least 4 episodes during the 2 weeks prior to initiation of study medication, prospectively documented in take-home binge diaries.
5.BMI < 50 kg/m2.
6.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..).
The following inclusion criterion is to be checked at randomization:
-Number of binge-eating days and number of episodes during the last 2 weeks.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

1.Patient with a current diagnosis of bulimia nervosa or anorexia nervosa.
2.History of bariatric surgery.
3.Clinically unstable and concomitant medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine, or other systemic disease.
4.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.
5.Suicidal ideation as evidenced by positive answer to questions 4 or 5 in the Columbia-Suicide-Severity Rating Scale (C-SSRS) at screening.
6.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.
7.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.
8.Regular cannabis consumption.
9.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.
10.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.
11.Ongoing alcohol or tobacco addiction treatment (except Nicotine Replacement Therapy [NRT] with at least one-month stable dose prior to screening visit).
12.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. barrier protection; 3. contraceptive implantation system; 4. oral contraceptive pills; 5. surgically sterile patient; and 6. abstinence. All participants should have a negative pregnancy test prior to randomization.
13.Uncontrolled hypertension (>160/100 mmHg).
14.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.
15.Prior (within the past 30 days prior to screening visit) or current therapy with any psychotropic medications including antidepressants (i.e., SSRIs, SNRIs, NRIs, monoamine oxidase inhibitors, either tricyclic or tetracyclic antidepressants), antipsychotics, antiepileptics, mood stabilizers, or psychostimulants, GLP-1 receptor agonists and therapy with herbal preparations and over-the-counter medications, except treatments for insomnia (e.g., hypnotics and sedative benzodiazepines).
16.Known hypersensitivity to the tested treatment including active substance and excipients.
17.Participation in clinical trial and receipt of investigational drug(s) during previous 60 days, except as explicitly approved by the Principal

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy and safety of BP1.4979 15 mg BID in patients with moderate to severe binge eating disorder (BED).;Secondary Objective: Not applicable;Primary end point(s): The primary efficacy endpoint will be the change in the total number of binge-eating (BE) episodes per week based on the self-reported BE diaries, from the 2-week baseline (Day-14 to Day 0) compared to the last 2 weeks at the end of treatment period (Day 43 to Day 56).;Timepoint(s) of evaluation of this end point: Evaluation performed at V2, V3 and V5

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary efficacy endpoints will include: <br>-Continuous Glucose Monitoring System (CGMS): to assess the number of dietary intakes (glycemic excursions) between meals identified as BE episodes by the Investigator.<br>-Change of the Yale Food Addiction Scale (YFAS) from baseline to Week 8.<br>-Change of the Clinical Global Impression (CGI) scale: CGI-Severity (CGI-S) and CGI-Improvement (CGI-I) from baseline to Week 8.<br>-Change in the number of BE days per week from baseline to Week 7 and Week 8.<br><br><br>;Timepoint(s) of evaluation of this end point: V0, V1, V2, V3, V5

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