Pilot Study on BP1.4979 Effect on Binge Eating Disorders

• Status: Not yet recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bioprojet

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).