The Effects of Oxytocin in Obese Adults
NCT03043053 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61
Last updated 2024-02-07
Summary
This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin in obese adults, ages 18-45 years old. Subjects will be randomized to receive of intranasal oxytocin or placebo (3 sprays per nostril, 4 times per day) for 8 weeks. Study visits include screening to determine eligibility, a 2-part baseline visit, and visits every 2 weeks thereafter until week 14, with a safety follow-up visit 6 weeks after the last dose of study drug. Study procedures include behavioral, metabolic, neuroimaging, and endocrine assessments.
Conditions
Interventions
- DRUG
-
oxytocin nasal spray
oxytocin intranasal spray
- DRUG
-
Placebo nasal spray
Sponsors & Collaborators
-
Massachusetts General Hospital
lead OTHER
Principal Investigators
-
Elizabeth A Lawson, MD · Massachusetts General Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-07-01
- Primary Completion
- 2022-05-20
- Completion
- 2022-07-07
- FDA Drug
- Yes
Countries
- United States
Study Locations
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