A Study of the Effects of Oxytocin in Adults With Obesity and Binge-eating Disorder

Study Overview
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Brief Summary
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This study evaluates the impact of intranasal oxytocin vs placebo in patients with obesity and binge eating disorder with obesity. We hypothesize that 8 weeks of intranasal oxytocin vs placebo will improve clinical outcomes [weight loss, reduction in bingeing frequency], and have a satisfactory safety and tolerability profile. We will also explore the predictive value of changes in homeostatic appetite, reward sensitivity, and impulse control, the identified underlying mediators, as assessed 4 weeks into the intervention, for treatment success after 8 weeks of the intervention

Detailed Description
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Study staff will screen patients for eligibility as per eligibility criteria. At least 60 eligible patients will be randomized 1:1 (active oxytocin: placebo) by an unblinded pharmacist. All other study staff and test subjects will be blinded. Study subject medical histories, physical exams, anthropometric measurements, labs, EKG's, and eating habits will be monitored over 8 weeks. Subjects will be evaluated at the following intervals: Baseline, week 2, week 4, and week 8.

Official Title
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A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Intranasal Oxytocin in Adults With Obesity and Binge- Eating Disorder

Conditions
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Binge-eating Disorder

Intervention / Treatment
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* Drug: TNX-1900 (Tonix Pharmaceuticals)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females, 18-45 years old BMI 30-50 kg/m2 BED as assessed by Structured Clinical Interview for DSM-5 Disorders (SCID-5-RV) Exclusion Criteria: Substance use disorder active within the last 6 months, or clinical suspicion of ongoing substance use disorder at the discretion of the study clinician at the time of screening based on history and/or laboratory results Medication changes within 4 weeks of baseline visit Use of prescription or over-the-counter drugs or dietary/herbal supplements for weight loss (e.g., lorcaserin, phentermine, topiramate, liraglutide). Metformin will be allowed if participants are on a stable dose with stable weight for at least 3 months History of any of the following medical conditions: inflammatory bowel disease; bariatric surgery (except for those participants with a history of laparoscopic adjustable gastric band surgery); epilepsy; untreated thyroid disease History of known cardiovascular disease, including coronary artery disease, heart failure, reduced ejection fraction, hypertrophic cardiomyopathy, ventricular arrhythmias, or prolonged QT Hematocrit >2% below normal Hemoglobin A1c >8% ALT or AST >2.5 times upper limit of normal Glomerular filtration rate < 60 mL/min Hyponatremia Pregnancy or breastfeeding Unwilling to use a medically acceptable form of contraception throughout the study period (female of child-bearing potential only) History of psychosis or active suicidality as assessed by the SCID-5-RV Weight change >5 kg within 3 months prior to randomization Current smoking or tobacco use Participation in any clinical study involving an investigational drug, device, or biologic within 1 month of randomization Any significant illness, condition, or medication that the Investigator determines could interfere with study participation and impact data collection or patient safety

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Arm<br>Solution without oxytocin | Drug: Placebo<br>* Nasal solution without oxytocin<br>|
| Experimental: TNX-1900<br>Solution with oxytocin | Drug: TNX-1900 (Tonix Pharmaceuticals)<br>* oxytocin nasal spray<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight (kg) | Change from baseline in weight | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binge Frequency | Change from baseline in binge frequency as assessed by the Eating Disorder Examination clinical interview | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxytocin, Obesity, Weight Loss, Binge, Binge-eating disorder, Overeating