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Hormone Therapy
The Effects of Oxytocin in Obese Adults
Phase 2
Waitlist Available
Led By Elizabeth A Lawson, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 8 weeks
Summary
This trial tests a nasal spray with oxytocin in adults to see if it can help with weight issues by affecting behaviors and metabolism. Oxytocin has been studied for its potential to reduce body weight and improve metabolic parameters in individuals.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean Difference in Weight Loss Between Oxytocin and Placebo 8 Weeks After Baseline
Secondary study objectives
Change in Fat Depots After 8 Weeks of Oxytocin Versus Placebo
Change in Resting Energy Expenditure After 8 Weeks of Oxytocin Versus Placebo
Difference in Caloric Intake After 6 Weeks of Oxytocin Versus Placebo
Side effects data
From 2022 Phase 2 trial • 61 Patients • NCT0304305319%
Nasal discomfort
16%
Headache
13%
Blood glucose increased
6%
Liver function test increased
6%
Wound complication
6%
Contusion
6%
Uterine pain
6%
Upper respiratory tract infection
3%
Arthralgia
3%
Carpal tunnel syndrome
3%
Nasal congestion
3%
Presyncope
3%
Ligament sprain
3%
Skin ulcer
3%
Anxiety
3%
Hemorrhoids
3%
Oedema
3%
COVID-19
3%
Thirst
3%
Acne
3%
Rash
3%
Sinus congestion
3%
Nausea
3%
Rhinorrhea
3%
Gastrointestinal viral infection
3%
Back pain
3%
Dysphoria
3%
Diarrhea
3%
Epistaxis
3%
Gastroesophageal reflux disease
3%
Constipation
3%
Abdominal discomfort
3%
Blood potassium increased
3%
Electrocardiogram QT prolonged
3%
Pain in extremity
3%
Parasthesia
3%
Dysuria
3%
Polyuria
3%
Dyspnea
3%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oxytocin
Placebo
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 8 weeks)
Group II: placeboPlacebo Group1 Intervention
placebo nasal spray (4 times per day for 8 weeks)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
oxytocin nasal spray
2017
Completed Phase 2
~70
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,026 Previous Clinical Trials
13,413,728 Total Patients Enrolled
74 Trials studying Obesity
292,473 Patients Enrolled for Obesity
Elizabeth A Lawson, MDPrincipal InvestigatorMassachusetts General Hospital
5 Previous Clinical Trials
238 Total Patients Enrolled
1 Trials studying Obesity
61 Patients Enrolled for Obesity