Pilot Study on BP1.4979 Effect on Binge Eating Disorders

A Double-blind, Placebo-controlled Pilot Trial of BP1.4979 for the Treatment of Binge Eating Disorder

This pilot study is to assess the efficacy and safety of BP1.4979 15 mg BID in female patients with moderate to severe binge eating disorder (BED), as defined according to DSM-5 guidelines.

Study Overview

• Status: Recruiting
• Conditions: Binge-Eating Disorder
• Intervention / Treatment: Drug: BP1.4979 active drug; Drug: Placebo

Detailed Description

First clinical study to assess the effect of the BP1.4979 on BED in female patients over an 8 week-tretament period.

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Recruiting
    • Nutrition Department, La Pitié Salpêtrière Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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
• BMI < 50 kg/m2.

Exclusion Criteria:

• Current diagnosis of bulimia nervosa or anorexia nervosa.
• History of bariatric surgery.
• 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
• Ongoing alcohol or tobacco addiction treatment (except Nicotine Replacement Therapy [NRT] with at least one-month stable dose prior to screening visit).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; matching placebo	Drug: Placebo; 2 tablets of placebo per day
EXPERIMENTAL: BP1.4979; 15 mg BID active treatment	Drug: BP1.4979 active drug; 2 tablets 15 mg of BP1.4979 per day; Other Names: BP1.4979

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binge Eating episodes per week	Number of Binge Eating episodes per week as measured during baseline and at the end of the treatment period	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binge Eating days per week	Number of Binge Eating days per week as measured during baseline and at the end of the treatment period	8 weeks
Quality of Life improvement (CGI-I)	Quality of life as per assessment on the Clinical Global Improvement (CGI-I) scale measured at randomization and at the end of the treatment period. The CGI is a 7-point scale that requires the clinician to assessment of the patient's illness at the beginning of the intervention (Baseline state) and rated as: 1, Normal, not at all ill; 2, Borderline mentally ill; 3, Mildly ill; 4, Moderately ill; 5, Markedly ill; 6, Severely ill; 7, Among the most extremely ill patients. The Clinical Global Impression-Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.	8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety assessed by AEs collection	Safety of BP1.4979 based on AEs reporting during the treatment period.	8 weeks

Collaborators and Investigators

• Sponsor: Bioprojet

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 7, 2022
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: October 28, 2021
• First Submitted That Met QC Criteria: November 2, 2021
• First Posted (ACTUAL): November 12, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Hyperphagia; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
• Other Study ID Numbers: P20-08 / BP1.4979; 2021-000472-11 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No