Adults 18 to 45, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mean Difference in Weight Loss Between Oxytocin and Placebo 8 Weeks After BaselinePrimary· Baseline to 8 weeks
The mean difference in weight loss between oxytocin- and placebo-treated groups from baseline to 8 weeks. All participants of the modified intention-to-treat cohort were aggregated into a single linear mixed effects model with the factors Time (Baseline, Week 2, Week 4, Week 6, and Week 8) and Group (oxytocin/placebo) and the interaction Time\*Group controlled for sex (male/female) and obesity class (class I, II, and III) to produce a single value (estimated mean difference) and 95% confidence interval for the difference between groups and a single value (estimated mean change) within each gro
Group
Value
95% CI
Oxytocin
0.20
Placebo
0.26
Change in Resting Energy Expenditure After 8 Weeks of Oxytocin Versus PlaceboSecondary· Baseline to 8 weeks
The mean difference in resting energy expenditure between oxytocin- and placebo-treated groups from baseline to 8 weeks. All participants of the modified intention-to-treat cohort were aggregated into a single linear mixed effects model with the factors Time (Baseline and Week 8) and Group (oxytocin/placebo) and the interaction Time\*Group controlled for sex (male/female), obesity class (class I, II, and III), and lean mass to produce a single value (estimated mean difference) and 95% confidence interval for the difference between groups and a single value (estimated mean change) within each g
Group
Value
95% CI
Oxytocin
-17.8
Placebo
11.8
Change in Fat Depots After 8 Weeks of Oxytocin Versus PlaceboSecondary· Baseline to 8 weeks
The mean difference in total fat mass between oxytocin- and placebo-treated groups from baseline to 8 weeks. All participants of the modified intention-to-treat cohort were aggregated into a single linear mixed effects model with the factors Time (Baseline and Week 8) and Group (oxytocin/placebo) and the interaction Time\*Group controlled for sex (male/female) and obesity class (class I, II, and III) to produce a single value (estimated mean difference) and 95% confidence interval for the difference between groups and a single value (estimated mean change) within each group.
Group
Value
95% CI
Oxytocin
248.5
Placebo
52.5
Difference in Caloric Intake After 6 Weeks of Oxytocin Versus PlaceboSecondary· Baseline to 6 weeks
The mean difference in caloric intake between oxytocin- and placebo-treated groups from baseline to 6 weeks. All participants of the modified intention-to-treat cohort were aggregated into a single linear mixed effects model with the factors Time (Baseline and Week 6) and Group (oxytocin/placebo) and the interaction Time\*Group controlled for sex (male/female) and obesity class (class I, II, and III) to produce a single value (estimated mean difference) and 95% confidence interval for the difference between groups and a single value (estimated mean change) within each group.
Group
Value
95% CI
Oxytocin
-31.4
Placebo
120.6
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline to Week 14 end of study.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06945926 — The Effect of Oxytocin Nasal Spray on Preventing Postoperative Delirium in Elderly Patients Undergoing Orthopedic Surger
· Phase 2
· not yet recruiting
NCT03577457 — The Interaction Between Oxytocin and Serotonin
· NA
· unknown
NCT03426176 — The Interaction Between Oxytocin and Serotonin
· NA
· unknown
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Massachusetts General Hospital
Last refreshed: 7 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03043053.