Pilot Study on BP1.4979 Effect on Binge Eating Disorders

Last updated: April 12, 2024
Sponsor: Bioprojet
Overall Status: Active - Recruiting

Phase

2

Condition

Bulimia

Binge Eating Disorder

Treatment

BP1.4979 active drug

Placebo

Clinical Study ID

NCT05118906
P20-08 / BP1.4979
2021-000472-11
  • Ages 18-65
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient must voluntarily express a willingness to participate in this study, sign anddate 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

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 usingadequate contraceptive measures. The following are considered adequate methods ofbirth control: 1. intrauterine device (IUD); 2. barrier protection; 3. contraceptiveimplantation system; 4. oral contraceptive pills; 5. surgically sterile patient; and
  1. abstinence. All participants should have a negative pregnancy test prior torandomization
  • Ongoing alcohol or tobacco addiction treatment (except Nicotine Replacement Therapy [NRT] with at least one-month stable dose prior to screening visit).

Study Design

Total Participants: 66
Treatment Group(s): 2
Primary Treatment: BP1.4979 active drug
Phase: 2
Study Start date:
March 07, 2022
Estimated Completion Date:
March 31, 2025

Study Description

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

Connect with a study center

  • Nutrition Department, La Pitié Salpêtrière Hospital

    Paris, 75013
    France

    Active - Recruiting

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