Pilot Study on BP1.4979 Effect on Binge Eating Disorders

Phase 2

Recruiting

• Conditions: Binge-Eating Disorder
• Interventions: Drug: BP1.4979 active drug; Drug: Placebo

• Registration Number: NCT05118906
• Lead Sponsor: Bioprojet

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-10-28
• Study First Submitted QC: 2021-11-02
• Study First Posted: 2021-11-12
• Study Start: 2022-03-07
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-12
• Last Update Posted: 2024-04-15
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BP1.4979	BP1.4979 active drug	15 mg BID active treatment
Placebo	Placebo	matching placebo

Primary Outcome Measures

Name	Time	Method
Binge Eating episodes per week	8 weeks	Number of Binge Eating episodes per week as measured during baseline and at the end of the treatment period

Secondary Outcome Measures

Name	Time	Method
Binge Eating days per week	8 weeks	Number of Binge Eating days per week as measured during baseline and at the end of the treatment period
Quality of Life improvement (CGI-I)	8 weeks	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.

Trial Locations

Locations (1)

Nutrition Department, La Pitié Salpêtrière Hospital; 🇫🇷 Paris, France