Trial · Interventional

CompletedPhase 2Results postedRegistry data

The Effects of Oxytocin in Obese Adults

NCTNCT03043053Other id2016P002810

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 61 participants (actual)
Sponsor: Massachusetts General Hospital · Other
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: 1 Jul 2017
Primary completion: 20 May 2022
Completion: 7 Jul 2022
First posted: 3 Feb 2017 (estimated)
Last update posted: 7 Feb 2024
Conditions: Obesity

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2017201820192020202120222023

Ph 2
The Effects of Oxytocin in Obese Adults
NCT03043053
1 Jul 2017 to 7 Jul 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

oxytocin nasal sprayDrug
PlaceboDrug

Arms2

Experimental
oxytocin
oxytocin nasal spray (24 IU nasal spray, 4 times per day for 8 weeks)
Placebo comparator
placebo
placebo nasal spray (4 times per day for 8 weeks)

Primary outcomes1

Outcomes the sponsor listed as primary.

Mean Difference in Weight Loss Between Oxytocin and Placebo 8 Weeks After Baseline
Time frame · Baseline to 8 weeks
Registry description
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 group.

Secondary outcomes(3)

Change in Resting Energy Expenditure After 8 Weeks of Oxytocin Versus Placebo
Time frame · Baseline to 8 weeks
Registry description
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 group. Reported are model estimates rounded to one decimal.
Change in Fat Depots After 8 Weeks of Oxytocin Versus Placebo
Time frame · Baseline to 8 weeks
Registry description
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.
Difference in Caloric Intake After 6 Weeks of Oxytocin Versus Placebo
Time frame · Baseline to 6 weeks
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Baseline to 8 weeks

Mean Difference in Weight Loss Between Oxytocin and Placebo 8 Weeks After Baseline

Group	Value (kilogram)
Oxytocin	0.20
Placebo	0.26

Secondary and other outcome results(3)

Secondary outcomeNumber· Baseline to 8 weeks

Change in Resting Energy Expenditure After 8 Weeks of Oxytocin Versus Placebo

Group	Value (kilocalories/day)
Oxytocin	-17.8
Placebo	11.8

Secondary outcomeNumber· Baseline to 8 weeks

Change in Fat Depots After 8 Weeks of Oxytocin Versus Placebo

Group	Value (gram)
Oxytocin	248.5
Placebo	52.5

Secondary outcomeNumber· Baseline to 6 weeks

Difference in Caloric Intake After 6 Weeks of Oxytocin Versus Placebo

Group	Value (kilocalories)
Oxytocin	-31.4
Placebo	120.6

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Oxytocinoxytocin nasal spray (24 IU nasal spray, 4 times per day for 8 weeks)	0 / 31	0 / 31	24 / 31
Placeboplacebo nasal spray (4 times per day for 8 weeks)	0 / 30	0 / 30	23 / 30

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2024

8 results

Intranasal Oxytocin for Obesity.

Plessow et al. 2024NEJM evidencecited by 22

PMID 38815173PMC11427243DOI 10.1056/evidoa2300349PUB-38815173

Rights unknown8 results

Source link See results (8)

More studies

1 study on this page

PubMed tag: none · 2026

Oxytocin-induced changes in free T3/free T4 ratio and relationship with quality of life in adults with obesity.

Galbiati et al. 2026The Journal of clinical endocrinology and metabolism

PMID 42714565DOI 10.1210/clinem/dgag291PUB-42714565

Full text at the publisher

Publisher page

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 45 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * 18-45 years old; * BMI greater than or equal to 30 kg/m2 Exclusion Criteria: * Use of drug affecting metabolism, glucose, or appetite (Metformin is allowed if dose and weight are stable for at least 3 months); * history of medication changes within 4 weeks of enrollment; * active substance use; * history of cardiovascular disease, gastrointestinal disorders, bariatric surgery, epilepsy, untreated thyroid disease; * hematocrit \>2% below normal; * fasting glucose \> 125 mg/dL or hemoglobin A1c ≥ 7% ; * ALT or AST \>2.5 times upper limit of normal; * Cr \>1.5 mg/dL; hyponatremia; * pregnancy or breastfeeding; * unwilling to use medically acceptable form of contraception (females only) * follows a nonstandard diet (e.g., gluten free, pescatarian, vegetarian, vegan, Paleo, Atkins, raw diet, macrobiotic diet) * current smoking or tobacco use

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