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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bioprojet Pharma

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Psychiatry and Psychology [F] - Behavior and Behavior Mechanisms [F01]

Trial duration

7 Mar 2022 → 24 Nov 2025

Decision date (initial)

2023-10-19

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Bioprojet Pharma

External identifiers

EU CT number

2023-506511-17-00

EudraCT number

2021-000472-11

ClinicalTrials.gov

NCT05118906

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To assess the efficacy and safety of BP1.4979 15 mg BID in female patients with moderate to severe binge eating disorder (BED).

Conditions and MedDRA coding

Binge eating disorder

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

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.
4. 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.
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..).

Exclusion criteria 19

1. Patient with a current diagnosis of bulimia nervosa or anorexia nervosa.
2. History of bariatric surgery in the past 5 years before study entry.
3. Clinically unstable and concomitant medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine, or other systemic disease.
4. Concomitant prolactin-dependent tumors (e.g., pituitary gland prolactinomas or breast cancer).
5. 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.
6. 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).
7. 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.
8. 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.
9. Regular cannabis consumption.
10. 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.
11. 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.
12. Ongoing alcohol or tobacco addiction treatment (except Nicotine Replacement Therapy [NRT] with at least one-month stable dose prior to screening visit).
13. 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).
14. Uncontrolled hypertension (>160/100 mmHg).
15. 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.
16. 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.
17. Known hypersensitivity to the tested treatment including active substance and excipients.
18. 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.
19. No health insurance.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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).

Secondary endpoints 4

1. Continuous Glucose Monitoring System (CGMS): to assess the number of dietary intakes (glycemic excursions) between meals identified as BE episodes by the Investigator.
2. Change of the Yale Food Addiction Scale (YFAS) from baseline to Week 8.
3. Change of the Clinical Global Impression (CGI) scale: CGI-Severity (CGI-S) and CGI-Improvement (CGI-I) from baseline to Week 8.
4. Change in the number of BE days per week from baseline to Week 7 and Week 8.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bioprojet Pharma

Sponsor organisation

Bioprojet Pharma

Address

9 Rue Rameau

City

Paris

Postcode

75002

Country

France

Scientific contact point

Organisation

Bioprojet Pharma

Contact name

Regulatory affairs manager

Public contact point

Organisation

Bioprojet Pharma

Contact name

Regulatory affairs manager

Locations

2 EU/EEA countries · 13 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 58 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

10 submissions — initial application plus substantial / non-substantial modifications