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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oxytocin | Experimental | oxytocin nasal spray (24 IU nasal spray, 4 times per day for 8 weeks) |
|
| placebo | Placebo Comparator | placebo nasal spray (4 times per day for 8 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oxytocin nasal spray | Drug | oxytocin intranasal spray |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Difference in Weight Loss Between Oxytocin and Placebo 8 Weeks After Baseline | 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. | Baseline to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Resting Energy Expenditure After 8 Weeks of Oxytocin Versus Placebo | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth A Lawson, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38815173 | Derived | Plessow F, Kerem L, Wronski ML, Asanza E, O'Donoghue ML, Stanford FC, Eddy KT, Holmes TM, Misra M, Thomas JJ, Galbiati F, Muhammed M, Sella AC, Hauser K, Smith SE, Holman K, Gydus J, Aulinas A, Vangel M, Healy B, Kheterpal A, Torriani M, Holsen LM, Bredella MA, Lawson EA. Intranasal Oxytocin for Obesity. NEJM Evid. 2024 May;3(5):EVIDoa2300349. doi: 10.1056/EVIDoa2300349. Epub 2024 Apr 23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxytocin | oxytocin nasal spray (24 IU nasal spray, 4 times per day for 8 weeks) oxytocin nasal spray: oxytocin intranasal spray |
| FG001 | Placebo | placebo nasal spray (4 times per day for 8 weeks) Placebo: Placebo nasal spray |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety cohort, which was defined as all randomly assigned participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxytocin | oxytocin nasal spray (24 IU nasal spray, 4 times per day for 8 weeks) oxytocin nasal spray: oxytocin intranasal spray |
| BG001 | Placebo | placebo nasal spray (4 times per day for 8 weeks) Placebo: Placebo nasal spray |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Difference in Weight Loss Between Oxytocin and Placebo 8 Weeks After Baseline | 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. | Modified Intention-To-Treat cohort, which includes all randomly assigned participants who completed at least 1 visit on study drug. | Posted | Number | kilogram | Baseline to 8 weeks |
|
Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oxytocin | oxytocin nasal spray (24 IU nasal spray, 4 times per day for 8 weeks) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular arrhythmia | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth A. Lawson, MD, MMSc | Massachusetts General Hospital | 617-726-3870 | ealawson@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 7, 2022 | Aug 22, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Placebo | Drug | Placebo nasal spray |
|
| Baseline to 8 weeks |
| Change in Fat Depots After 8 Weeks of Oxytocin Versus Placebo | 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. | Baseline to 8 weeks |
| Difference in Caloric Intake After 6 Weeks of Oxytocin Versus Placebo | 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. | Baseline to 6 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
oxytocin nasal spray (24 IU nasal spray, 4 times per day for 8 weeks)
| OG001 | Placebo | placebo nasal spray (4 times per day for 8 weeks) |
|
|
|
| Secondary | Change in Resting Energy Expenditure After 8 Weeks of Oxytocin Versus Placebo | 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. | Modified Intention-to-Treat cohort, which includes all randomly assigned participants who completed at least 1 visit on study drug. | Posted | Number | kilocalories/day | Baseline to 8 weeks |
|
|
|
|
| Secondary | Change in Fat Depots After 8 Weeks of Oxytocin Versus Placebo | 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. | Modified Intention-To-Treat cohort, which includes all randomly assigned participants who completed at least 1 visit on study drug. | Posted | Number | gram | Baseline to 8 weeks |
|
|
|
|
| Secondary | Difference in Caloric Intake After 6 Weeks of Oxytocin Versus Placebo | 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. | Modified Intention-To-Treat cohort, which includes all randomly assigned participants who completed at least 1 visit on study drug. | Posted | Number | kilocalories | Baseline to 6 weeks |
|
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 24 |
| 31 |
| EG001 | Placebo | placebo nasal spray (4 times per day for 8 weeks) | 0 | 30 | 0 | 30 | 23 | 30 |
| Ear pain | Ear and labyrinth disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal distention | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal tenderness | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Gastrointestinal viral infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Liver function test increased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Polydipsia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Thirst | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Osteitis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Parasthesia | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dysphoria | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hypersomnia | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Polyuria | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Uterine pain | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Skin infection | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Wound complication | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Presyncope | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |