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NCT03043053

The Effects of Oxytocin in Obese Adults

Completed Phase 2 Results posted Last updated 7 February 2024
What this trial tests

Phase 2 trial testing oxytocin nasal spray in Obesity in 61 participants. Completed in 7 July 2022.

Timeline
1 July 2017
Primary endpoint
20 May 2022
7 July 2022

Quick facts

Lead sponsorMassachusetts General Hospital
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment61
Start date1 July 2017
Primary completion20 May 2022
Estimated completion7 July 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Massachusetts General Hospital

Who can join

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 Baseline Primary · 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

GroupValue95% CI
Oxytocin0.20
Placebo0.26
Change in Resting Energy Expenditure After 8 Weeks of Oxytocin Versus Placebo Secondary · 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

GroupValue95% CI
Oxytocin-17.8
Placebo11.8
Change in Fat Depots After 8 Weeks of Oxytocin Versus Placebo Secondary · 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.

GroupValue95% CI
Oxytocin248.5
Placebo52.5
Difference in Caloric Intake After 6 Weeks of Oxytocin Versus Placebo Secondary · 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.

GroupValue95% CI
Oxytocin-31.4
Placebo120.6

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.

Oxytocin
Serious: 0/31 (0%)
Deaths: 0/31
Placebo
Serious: 0/30 (0%)
Deaths: 0/30
Other adverse events (58 terms — click to expand)

ReactionSystemOxytocinPlacebo
HeadacheNervous system disorders
Nasal discomfortRespiratory, thoracic and mediastinal disorders
Blood glucose increasedInvestigations
Liver function test increasedInvestigations
EpistaxisRespiratory, thoracic and mediastinal disorders
Abdominal tendernessGastrointestinal disorders
ConstipationGastrointestinal disorders
DiarrheaGastrointestinal disorders
NauseaGastrointestinal disorders
COVID-19Infections and infestations
ContusionInjury, poisoning and procedural complications
DysphoriaPsychiatric disorders
Uterine painReproductive system and breast disorders
CoughRespiratory, thoracic and mediastinal disorders
Nasal congestionRespiratory, thoracic and mediastinal disorders
Upper respiratory tract infectionRespiratory, thoracic and mediastinal disorders
AcneSkin and subcutaneous tissue disorders
RashSkin and subcutaneous tissue disorders
Wound complicationSkin and subcutaneous tissue disorders
HypertensionVascular disorders
Ventricular arrhythmiaCardiac disorders
Ear painEar and labyrinth disorders
Abdominal discomfortGastrointestinal disorders
Abdominal distentionGastrointestinal disorders
Gastroesophageal reflux diseaseGastrointestinal disorders
HemorrhoidsGastrointestinal disorders
Chest painGeneral disorders
OedemaGeneral disorders
Gastrointestinal viral infectionInfections and infestations
InfluenzaInfections and infestations
Ligament sprainInjury, poisoning and procedural complications
Limb injuryInjury, poisoning and procedural complications
Blood potassium decreasedInvestigations
Blood potassium increasedInvestigations
Electrocardiogram QT prolongedInvestigations
Blood sodium decreasedInvestigations
GoutMetabolism and nutrition disorders
PolydipsiaMetabolism and nutrition disorders
ThirstMetabolism and nutrition disorders
ArthralgiaMusculoskeletal and connective tissue disorders

Data from ClinicalTrials.gov NCT03043053 adverse events section.

Sponsor's own description

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):

  1. Pharmacotherapy of obesity: an update on the available medications and drugs under investigation.
    Chakhtoura M, Haber R, Ghezzawi M, Rhayem C, et al · · 2023 · cited 260× · PMID 36992862 · DOI 10.1016/j.eclinm.2023.101882
  2. The effects of oxytocin on eating behaviour and metabolism in humans.
    Lawson EA. · · 2017 · cited 158× · PMID 28960210 · DOI 10.1038/nrendo.2017.115
  3. Metabolic Effects of Oxytocin.
    McCormack SE, Blevins JE, Lawson EA. · · 2020 · cited 104× · PMID 31803919 · DOI 10.1210/endrev/bnz012
  4. Comprehensive Review of Current and Upcoming Anti-Obesity Drugs.
    Son JW, Kim S. · · 2020 · cited 92× · PMID 33389955 · DOI 10.4093/dmj.2020.0258
  5. Novel Noninvasive Approaches to the Treatment of Obesity: From Pharmacotherapy to Gene Therapy.
    Angelidi AM, Belanger MJ, Kokkinos A, Koliaki CC, et al · · 2022 · cited 83× · PMID 35552683 · DOI 10.1210/endrev/bnab034
  6. The role of oxytocin in regulation of appetitive behaviour, body weight and glucose homeostasis.
    Lawson EA, Olszewski PK, Weller A, Blevins JE. · · 2020 · cited 82× · PMID 31657509 · DOI 10.1111/jne.12805
  7. Oxytocin in metabolic homeostasis: implications for obesity and diabetes management.
    Ding C, Leow MK, Magkos F. · · 2019 · cited 72× · PMID 30253045 · DOI 10.1111/obr.12757
  8. The Effects of Oxytocin on Appetite Regulation, Food Intake and Metabolism in Humans.
    Kerem L, Lawson EA. · · 2021 · cited 68× · PMID 34299356 · DOI 10.3390/ijms22147737

Verify or expand the search:

Other trials of oxytocin nasal spray

Trials testing the same drug.

Other recruiting trials for Obesity

Currently open trials in the same condition.

Other Massachusetts General Hospital trials

Trials by the same sponsor.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing