Assessing BP1.4979 for treating binge eating disorder in women
A Double-blind, Placebo-controlled Pilot Trial of BP1.4979 for the Treatment of Binge Eating Disorder
This study is testing if a new medication called BP1.4979 can help women with binge eating disorder feel better over an 8-week period.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Bioprojet Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT05118906 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the efficacy and safety of BP1.4979, administered at a dose of 15 mg twice daily, in female patients diagnosed with moderate to severe binge eating disorder (BED) according to DSM-5 criteria. Over an 8-week treatment period, participants will receive either the active drug or a placebo to determine the drug's impact on their condition. The study aims to provide initial insights into the potential benefits of BP1.4979 for managing BED.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 to 65 with a diagnosis of moderate to severe binge eating disorder and a BMI under 50 kg/m2.
Not a fit: Patients with current diagnoses of bulimia nervosa or anorexia nervosa, or those who have undergone bariatric surgery, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for women suffering from binge eating disorder.
How similar studies have performed: This is the first clinical study assessing BP1.4979 for binge eating disorder, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Paris
- Nutrition Department, La Pitié Salpêtrière Hospital — Paris, France (Recruiting)
Study contacts
- Principal investigator: Karine Clément, MD, PhD — Nutrition Department, La Pitié Salpêtrière Hospital, Paris
- Study coordinator: Patricia Rodriguez, PhD
- Email: p.rodriguez@bioprojet.com
- Phone: +33147036633
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.