Frontlight ResearchEarly access
CompletedPhase 2
Pilot Study on BP1.4979 Effect on Binge Eating Disorders
Key facts
- Who runs it
- Bioprojet
- Where
- France and Spain13 sites in 2 countriesChoose a country to see its sites
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 67 people enrolled
- Started
- 7 Mar 2022
- Ended
- 21 Aug 2025
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- BP1.4979 active drug
- Placebo
- Record updated
- 25 November 2025
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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)
- History of bariatric surgery
- Current diagnosis of bulimia nervosa or anorexia nervosa
This trial has no sites in United States.
It has sites in 2 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- BP1.4979Treatment being tested
15 mg BID active treatment
Treatment: BP1.4979 active drug
- PlaceboPlacebo, for comparison
matching placebo
Data and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Double-blind, Placebo-controlled Pilot Trial of BP1.4979 for the Treatment of Binge Eating Disorder
- Record updated
- 25 November 2025