NCT04551482

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
11mo left

Started Jul 2021

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Jul 2021Mar 2027

First Submitted

Initial submission to the registry

August 31, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

July 28, 2021

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

July 20, 2025

Status Verified

July 1, 2025

Enrollment Period

4.9 years

First QC Date

August 31, 2020

Last Update Submit

July 16, 2025

Conditions

Obesity, AdolescentOxytocin

Outcome Measures

Primary Outcomes (3)

  • Weight

    Mean difference in weight between Oxytocin and Placebo group after 12 weeks of treatment

    12 weeks

  • Height

    Measure height on a stadiometer to the nearest 0.1 cm

    Baseline

  • Body mass index (BMI)

    Mean difference in BMI between Oxytocin and Placebo group after 12 weeks of treatment. BMI will be calculated as weight/height2

    12 weeks

Secondary Outcomes (2)

  • Lean mass and Fat mass

    12 weeks

  • Fasting Resting Energy Expenditure (kCal)

    12 weeks

Study Arms (2)

Oxytocin

EXPERIMENTAL

Oxytocin nasal spray (24 IU nasal spray, 4 times per day for 12 weeks)

Drug: Oxytocin nasal spray

Placebo

PLACEBO COMPARATOR

Placebo nasal spray (24 IU nasal spray, 4 times per day for 12 weeks)

Drug: Placebo

Interventions

Oxytocin nasal sprayDRUG

24 IU nasal spray, 4 times per day for 12 weeks

Also known as: Syntocin
Oxytocin
PlaceboDRUG

24 IU nasal spray, 4 times per day for 12 weeks

Placebo

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Active substance abuse
  • Use of prescription or over-the-counter drugs or dietary/herbal supplements for the purpose of weight loss. Medications/supplements that may affect weight will be allowed if participants are on a stable dose with stable weight for at least 3 months.
  • Greater than 5kg weight loss over 3 months;
  • Follows a nonstandard diet (e.g., gluten-free, vegan, Paleo, Atkins, raw diet, macrobiotic diet)
  • Cardiovascular disease
  • Prolonged QT interval
  • Chronic gastrointestinal disorders and other inflammatory conditions
  • Epilepsy
  • Untreated thyroid disease
  • Alanine transaminase (ALT) or aspartate transaminase (AST) \>2.5 times upper limit of normal
  • Creatinine \>1.5 mg/dl
  • Hyponatremia
  • Pregnancy/breastfeeding or refusal to use contraception not containing estrogen throughout the study if female and sexually active
  • Weight \>450 lbs due to limits for MRI and DXA scanners
  • Type 1 Diabetes Mellitus or Type 2 Diabetes Mellitus if HbA1c \>8%
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Elizabeth Lawson, MD, MMSc

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth A Lawson, MD, MMSc

CONTACT

617-726-3870ealawson@partners.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 31, 2020

First Posted

September 16, 2020

Study Start

July 28, 2021

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

July 20, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)