Pilot Study on BP1.4979 Effect on Binge Eating Disorders

Bioprojet

Status and phase: Active, not recruiting; Phase 2

Conditions: Binge-Eating Disorder

Treatments: Drug: Placebo; Drug: BP1.4979 active drug

Study type: Interventional

Funder types: Other

Identifiers

NCT05118906

P20-08 / BP1.4979

2021-000472-11 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 66 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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66 participants in 2 patient groups, including a placebo group

BP1.4979

Experimental group

Description:

15 mg BID active treatment

Treatment:

Drug: BP1.4979 active drug

Placebo

Placebo Comparator group

Description:

matching placebo

Treatment:

Drug: Placebo