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
2 other identifiers
interventional
67
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2022
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2021
CompletedFirst Posted
Study publicly available on registry
November 12, 2021
CompletedStudy Start
First participant enrolled
March 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 14, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 21, 2025
CompletedNovember 25, 2025
November 1, 2025
3.4 years
October 28, 2021
November 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Binge Eating days per week
8 weeks
Quality of Life improvement (CGI-I)
8 weeks
Other Outcomes (1)
Safety assessed by AEs collection
8 weeks
Study Arms (2)
BP1.4979
EXPERIMENTAL15 mg BID active treatment
Placebo
PLACEBO COMPARATORmatching placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bioprojetlead
Study Sites (1)
Nutrition Department, La Pitié Salpêtrière Hospital
Paris, 75013, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karine Clément, MD, PhD
Nutrition Department, La Pitié Salpêtrière Hospital, Paris
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2021
First Posted
November 12, 2021
Study Start
March 7, 2022
Primary Completion
August 14, 2025
Study Completion
August 21, 2025
Last Updated
November 25, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share