Oxytocin as a Neuroendocrine Therapy for Obesity in Youth

Who is this study for? Youths with obesity
What treatments are being studied? Oxytocin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin in youths with obesity, ages 12-18 years old. Subjects will be randomized to receive intranasal oxytocin or placebo (1 spray per nostril, 4 times per day) for 12 weeks. Study visits include screening to determine eligibility, 2-part main study visits at baseline, week 8, and week 12, and safety check-in visits at weeks 1, and 4; phone calls at weeks 2, 6, and 10, with a safety follow-up visit 6 weeks after the last dose of study drug. Study procedures include appetite, behavioral, metabolic, and endocrine assessments.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 18
Healthy Volunteers: f
View:

• Males and Females, 10-18 years

• Obesity (BMI ≥95th percentile for age and gender)

• Willingness to maintain current diet and lifestyle for the duration of study participation

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Elizabeth A Lawson, MD, MMSc
ealawson@partners.org
617-726-3870
Time Frame
Start Date: 2021-07-28
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 75
Treatments
Experimental: Oxytocin
Oxytocin nasal spray (24 IU nasal spray, 4 times per day for 12 weeks)
Placebo_comparator: Placebo
Placebo nasal spray (24 IU nasal spray, 4 times per day for 12 weeks)
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov

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