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Hormone Therapy

Oxytocin for Adolescent Obesity

Phase 2
Recruiting
Led By Madhusmita Misra, MD, MPH
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males and Females, 12-18 years
Obesity (BMI ≥95th percentile for age and gender)
Must not have
Untreated thyroid disease
Type 1 and type 2 Diabetes Mellitus if HbA1c >8%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks

Summary

This trialtests if a nose spray can help youths with obesity by assessing appetite, behavior, metabolism, and hormones.

Who is the study for?
This trial is for overweight adolescents aged 12-18 with a BMI in the top 5% for their age and gender. They must be willing to keep their diet and lifestyle unchanged during the study. Those with certain medical conditions, significant recent weight changes, or on specific diets or medications that affect metabolism are excluded.
What is being tested?
The study tests if oxytocin nasal spray helps with weight loss compared to a placebo. Participants will use either the real spray or placebo four times daily for three months, while researchers monitor appetite, behavior, metabolism, and hormones.
What are the potential side effects?
Potential side effects of oxytocin may include temporary discomfort at the site of spraying such as runny nose or sneezing; more systemic effects could involve changes in mood or behavior but these are less common.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 12 and 18 years old.
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My BMI is in the top 5% for my age and gender.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a thyroid condition that hasn't been treated.
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My diabetes is not well-controlled, with an HbA1c over 8%.
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I have epilepsy.
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I am not pregnant or breastfeeding and agree to use non-estrogen contraception if I'm sexually active.
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I am currently taking oral contraceptive pills.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Body mass index (BMI)
Height
Weight
Secondary study objectives
Fasting Resting Energy Expenditure (kCal)
Lean mass and Fat mass

Side effects data

From 2019 Phase 1 & 2 trial • 23 Patients • NCT03119610
58%
Dizziness
42%
Allergic Rhinitis
42%
Nausea
33%
Headache
17%
Nasal Irritation
17%
Sore Throat
17%
Lightheaded
8%
Neck Pain
8%
Bruise related to biopsy
8%
Confusion
8%
Skin Rash
8%
Sinus Disorder
8%
Anorexia
8%
Throat itching
8%
Muscle Aches
8%
Upset stomach
8%
Migraine
8%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Nasal Spray
Oxytocin Nasal Spray

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: OxytocinExperimental Treatment1 Intervention
Oxytocin nasal spray (24 IU nasal spray, 4 times per day for 12 weeks)
Group II: PlaceboPlacebo Group1 Intervention
Placebo nasal spray (24 IU nasal spray, 4 times per day for 12 weeks)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxytocin nasal spray
2016
Completed Phase 4
~1600

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,463 Previous Clinical Trials
4,337,328 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
3,026 Previous Clinical Trials
13,413,736 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,838 Previous Clinical Trials
8,171,873 Total Patients Enrolled
Madhusmita Misra, MD, MPHPrincipal InvestigatorMassachusetts General Hospital
2 Previous Clinical Trials
196 Total Patients Enrolled
Elizabeth Lawson, MD, MMScPrincipal InvestigatorMassachusetts General Hospital

Media Library

Oxytocin nasal spray (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04551482 — Phase 2
Oxytocin Research Study Groups: Placebo, Oxytocin
Oxytocin Clinical Trial 2023: Oxytocin nasal spray Highlights & Side Effects. Trial Name: NCT04551482 — Phase 2
Oxytocin nasal spray (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04551482 — Phase 2
~23 spots leftby Jun 2026
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