Binge-Eating DisorderPhase 2NCT05118906
Pilot Study on BP1.4979 Effect on Binge Eating Disorders
A Phase 2 study testing BP1.4979 active drug in people with Binge-Eating Disorder, run by Bioprojet at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Binge-Eating Disorder
- What is being tested?
- BP1.4979 active drug
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteFrance
- Study dates
- 7 Mar 2022to 21 Aug 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Placebo-controlled Pilot Trial of BP1.4979 for the Treatment of Binge Eating Disorder
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.
Read the detailed description
First clinical study to assess the effect of the BP1.4979 on BED in female patients over an 8 week-tretament period.
- Conditions
- Binge-Eating Disorder
- Being tested
- BP1.4979 active drug, Placebo
- Medical subject headings
- Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BP1.4979 active drugDrug
Also called BP1.4979
2 tablets 15 mg of BP1.4979 per day
PlaceboDrug
2 tablets of placebo per day
| Study group | Role | What they receive |
|---|---|---|
| BP1.4979 | Experimental | 15 mg BID active treatment Receives: Drug: BP1.4979 active drug |
| Placebo | Placebo comparator | matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binge Eating episodes per week
Number of Binge Eating episodes per week as measured during baseline and at the end of the treatment period
Measured: 8 weeks
Secondary outcomes (2)
Binge Eating days per week
Number of Binge Eating days per week as measured during baseline and at the end of the treatment period
Measured: 8 weeks
Quality of Life improvement (CGI-I)
Quality of life as per assessment on the Clinical Global Improvement (CGI-I) scale measured at randomization and at the end of the treatment period. The CGI is a 7-point scale that requires the clinician to assessment of the patient's illness at the beginning of the intervention (Baseline state) and rated as: 1, Normal, not at all ill; 2, Borderline mentally ill; 3, Mildly ill; 4, Moderately ill; 5, Markedly ill; 6, Severely ill; 7, Among the most extremely ill patients.
The Clinical Global Impression-Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study start7 Mar 2022
- Primary completion14 Aug 2025
- Study completion21 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge-Eating DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioprojet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karine Clément, MD, PhD, Principal investigator, Nutrition Department, La Pitié Salpêtrière Hospital, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118906
- Sponsor's protocol ID
- P20-08 / BP1.4979
- Other IDs
- 2021-000472-11
- Status last verified
- Nov 2025
- First submitted
- 28 Oct 2021
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled Pilot Trial of BP1.4979 for the Treatment of Binge Eating Disorder
- ClinicalTrials.gov ID
- NCT05118906
- Acronym / sponsor ID
- P20-08 / BP1.4979
- Conditions
- Binge-Eating Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- BioprojetUniversity, hospital or other
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 14 Aug 2025 (actual)
- Study completion
- 21 Aug 2025 (actual)
- First posted
- 12 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
First clinical study to assess the effect of the BP1.4979 on BED in female patients over an 8 week-tretament period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BP1.4979 | Experimental | Drug: BP1.4979 active drug15 mg BID active treatment |
| Placebo | Placebo comparator | Drug: Placebomatching placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BP1.4979 active drugAlso: BP1.49792 tablets 15 mg of BP1.4979 per day | Drug | BP1.4979 |
| Placebo2 tablets of placebo per day | Drug | Placebo |
Primary outcome
Binge Eating episodes per week
Time frame: 8 weeks
Number of Binge Eating episodes per week as measured during baseline and at the end of the treatment period
2 secondary outcomes
Binge Eating days per week
Time frame: 8 weeks
Quality of Life improvement (CGI-I)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Binge-Eating Disorder
Not yet recruiting
FUS Neuromodulation for Binge Eating Disorder
Binge-Eating Disorder
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
RecruitingObservational study
Children s Growth and Behavior Study
Obesity, Eating Behaviors
Not yet recruiting
Cognitive and Behavioral Approaches to Reduce Binge Eating and Excess Weight in Adolescents (Online)
Binge Eating, Overweight and Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karine Clément, MD, PhD principal investigator
Nutrition Department, La Pitié Salpêtrière Hospital, Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BP1.4979 active drug in people with Binge-Eating Disorder, run by Bioprojet at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binge Eating episodes per week (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.