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

Phase 2

Recruiting

• Conditions: Binge-eating Disorder
• Interventions: Drug: Placebo; Drug: TNX-1900 (Tonix Pharmaceuticals)

• Registration Number: NCT05664516
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-12-16
• Study First Submitted QC: 2022-12-16
• Study First Posted: 2022-12-23
• Status Verified: 2023-03
• Study Start: 2023-03-07
• Last Update Submitted: 2023-03-22
• Last Update Posted: 2023-03-24
• Primary Completion: 2024-04
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Arm	Placebo	Solution without oxytocin
TNX-1900	TNX-1900 (Tonix Pharmaceuticals)	Solution with oxytocin

Primary Outcome Measures

Name	Time	Method
weight (kg)	8 weeks	Change from baseline in weight

Secondary Outcome Measures

Name	Time	Method
Binge Frequency	8 weeks	Change from baseline in binge frequency as assessed by the Eating Disorder Examination clinical interview

Trial Locations

Locations (1)

Neuroendocrine Unit Research Center; 🇺🇸 Boston, Massachusetts, United States