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Completed

NCT Number: NCT05118906

Pilot Study on BP1.4979 Effect on Binge Eating Disorders

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.

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Key information

Conditions

Binge-Eating Disorder Feeding and Eating Disorders Mental Disorders

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Nutrition Department, La Pitié Salpêtrière Hospital

Paris, 75013, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

BP1.4979 active drug

Drug

2 tablets 15 mg of BP1.4979 per day

Other names: BP1.4979

Placebo

Drug

2 tablets of placebo per day

Primary outcomes

  1. Binge Eating episodes per week

    Time frame: 8 weeks

    Number of Binge Eating episodes per week as measured during baseline and at the end of the treatment period

Secondary outcomes

  1. Binge Eating days per week

    Time frame: 8 weeks

    Number of Binge Eating days per week as measured during baseline and at the end of the treatment period

  2. Quality of Life improvement (CGI-I)

    Time frame: 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.

Other outcomes

  1. Safety assessed by AEs collection

    Time frame: 8 weeks

    Safety of BP1.4979 based on AEs reporting during the treatment period.

Sponsors and collaborators

Lead sponsor

Bioprojet

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 12, 2021
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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