ObesityPhase 2NCT03043053
The Effects of Oxytocin in Obese Adults
A Phase 2 study testing oxytocin nasal spray in people with Obesity, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Obesity
- What is being tested?
- oxytocin nasal spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 7 Jul 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-45 years old;
- BMI greater than or equal to 30 kg/m2
Who cannot join
- 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% ;
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Repeat Doses of Intranasal Oxytocin in Obese Adults
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.
- Conditions
- Obesity
- Being tested
- oxytocin nasal spray, Placebo
- Keywords
- weight loss, body mass index, oxytocin, magnetic resonance imaging
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxytocin nasal sprayDrug
Also called Syntocinon
oxytocin intranasal spray
PlaceboDrug
Placebo nasal spray
| Study group | Role | What they receive |
|---|---|---|
| oxytocin | Experimental | oxytocin nasal spray (24 IU nasal spray, 4 times per day for 8 weeks) Receives: Drug: oxytocin nasal spray |
| placebo | Placebo comparator | placebo nasal spray (4 times per day for 8 weeks) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 8 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start1 Jul 2017
- Primary completion20 May 2022
- Study completion7 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Austen Lawson, Massachusetts General Hospital
- Investigators
- Elizabeth A Lawson, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043053
- Sponsor's protocol ID
- 2016P002810
- Status last verified
- Jan 2024
- First submitted
- 1 Feb 2017
- Last updated
- 7 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Galbiati F, Wronski ML, Bitar T, Bikas A, Lamont H, Hiranandani S, Holman K, Eddy KT, Asanza E, Smith S, Muhammed M, Plessow F, Aulinas A, Lawson EA. Oxytocin-induced changes in free T3/free T4 ratio and relationship with quality of life in adults with obesity. J Clin Endocrinol Metab. 2026 Sep 9:dgag291. doi: 10.1210/clinem/dgag291. Online ahead of print.
PubMed 42714565Plessow 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.
PubMed 38815173
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Repeat Doses of Intranasal Oxytocin in Obese Adults
- ClinicalTrials.gov ID
- NCT03043053
- Acronym / sponsor ID
- 2016P002810
- Conditions
- Obesity
- Keywords
- weight loss, body mass index, oxytocin, magnetic resonance imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 3 Feb 2017 (estimated)
- Results
- Posted 7 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oxytocin | Experimental | Drug: oxytocin nasal sprayoxytocin nasal spray (24 IU nasal spray, 4 times per day for 8 weeks) |
| placebo | Placebo comparator | Drug: Placeboplacebo nasal spray (4 times per day for 8 weeks) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-45 years old;
- BMI greater than or equal to 30 kg/m2
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxytocin nasal sprayAlso: Syntocinonoxytocin intranasal spray | Drug | oxytocin |
| PlaceboPlacebo nasal spray | Drug | placebo |
Primary outcome
Mean Difference in Weight Loss Between Oxytocin and Placebo 8 Weeks After Baseline
Time frame: 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 group.
3 secondary outcomes
Change in Resting Energy Expenditure After 8 Weeks of Oxytocin Versus Placebo
Time frame: Baseline to 8 weeks
Change in Fat Depots After 8 Weeks of Oxytocin Versus Placebo
Time frame: Baseline to 8 weeks
Difference in Caloric Intake After 6 Weeks of Oxytocin Versus Placebo
Time frame: Baseline to 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42714565Galbiati F, Wronski ML, Bitar T, Bikas A, Lamont H, Hiranandani S, Holman K, Eddy KT, Asanza E, Smith S, Muhammed M, Plessow F, Aulinas A, Lawson EA. Oxytocin-induced changes in free T3/free T4 ratio and relationship with quality of life in adults with obesity. J Clin Endocrinol Metab. 2026 Sep 9:dgag291. doi: 10.1210/clinem/dgag291. Online ahead of print.
- Derived from this study: PubMed 38815173Plessow 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth A Lawson, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing oxytocin nasal spray in people with Obesity, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Difference in Weight Loss Between Oxytocin and Placebo 8 Weeks After Baseline (time frame: Baseline to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03043053, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.