Oxytocin for Adolescent Obesity

Overseen By Elizabeth A Lawson, MD

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

Must not be taking: Weight loss drugs

Disqualifiers: Substance abuse, Cardiovascular disease, Epilepsy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 10

Duration: 12 weeks

75 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin in youths with obesity, ages 12-18 years old. Subjects will be randomized to receive intranasal oxytocin or placebo (1 spray per nostril, 4 times per day) for 12 weeks. Study visits include screening to determine eligibility, 2-part main study visits at baseline, week 8, and week 12, and safety check-in visits at weeks 1, and 4; phone calls at weeks 2, 6, and 10, with a safety follow-up visit 6 weeks after the last dose of study drug. Study procedures include appetite, behavioral, metabolic, and endocrine assessments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking medications or supplements for weight loss, you cannot participate unless you have been on a stable dose with stable weight for at least 3 months.

What evidence supports the effectiveness of the drug oxytocin nasal spray for treating adolescent obesity?

Research shows that oxytocin can help reduce food intake and promote weight loss in both animal models and humans with obesity. Studies have found that oxytocin nasal spray can lead to weight loss by decreasing calorie consumption and increasing energy use, making it a promising option for obesity treatment. ^{1 2 3 4 5}

Is oxytocin nasal spray safe for use in humans?

Research shows that oxytocin nasal spray is generally safe in humans, with most side effects being mild, such as nasal discomfort and tiredness. Severe side effects are rare, and the treatment is well-tolerated in both children and adults. ^{2 6 7 8 9}

How is the drug oxytocin nasal spray different from other obesity treatments?

Oxytocin nasal spray is unique because it targets the brain to help control appetite and energy balance, potentially leading to weight loss without the psychiatric or cardiovascular side effects often seen with other obesity treatments. It works by reducing food intake and increasing energy expenditure, and it can be effective even in cases where the body is resistant to leptin, a hormone that regulates hunger. ^{1 2 3 4 10}

Research Team

Elizabeth A Lawson, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for overweight adolescents aged 12-18 with a BMI in the top 5% for their age and gender. They must be willing to keep their diet and lifestyle unchanged during the study. Those with certain medical conditions, significant recent weight changes, or on specific diets or medications that affect metabolism are excluded.

Inclusion Criteria

You agree to keep your current diet and lifestyle throughout the study.

My BMI is in the top 5% for my age and gender.

Exclusion Criteria

You currently have an eating disorder that is not under control.

You are following a specialized diet such as gluten-free, vegan, Paleo, Atkins, raw diet, macrobiotic diet.

I have a thyroid condition that hasn't been treated.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive intranasal oxytocin or placebo for 12 weeks

12 weeks

Main study visits at baseline, week 8, and week 12; safety check-in visits at weeks 1 and 4; phone calls at weeks 2, 6, and 10

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

1 safety follow-up visit (in-person)

Treatment Details

Interventions

• Oxytocin nasal spray
• Placebo

Trial Overview The study tests if oxytocin nasal spray helps with weight loss compared to a placebo. Participants will use either the real spray or placebo four times daily for three months, while researchers monitor appetite, behavior, metabolism, and hormones.

Participant Groups

Group I: Oxytocin Experimental Treatment 1 Intervention

Oxytocin nasal spray (24 IU nasal spray, 4 times per day for 12 weeks)

Group II: Placebo Placebo Group 1 Intervention

Placebo nasal spray (24 IU nasal spray, 4 times per day for 12 weeks)

Oxytocin nasal spray is already approved in United States, European Union for the following indications:

Approved in United States as Pitocin for:

• Induction of labor
• Stimulation of uterine contractions

Approved in European Union as Syntocinon for:

• Induction of labor
• Stimulation of uterine contractions

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

Chronic administration of oxytocin (OT) has been shown to reduce food intake and promote weight loss in various models, including diet-induced obese mice, nonhuman primates, and pre-diabetic obese humans, indicating its potential as a treatment for obesity.

OT appears to be effective at doses that do not lead to tolerance, suggesting a promising therapeutic strategy for managing obesity and its related complications without diminishing effectiveness over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translational and therapeutic potential of oxytocin as an anti-obesity strategy: Insights from rodents, nonhuman primates and humans. Blevins, JE., Baskin, DG.[2022]

A randomized, double-blind, placebo-controlled trial is being conducted to evaluate the efficacy and safety of intranasal oxytocin for weight loss in 61 adults with obesity, aged 18-45 years, over an eight-week period.

The study aims to assess not only weight loss but also changes in energy expenditure, body composition, and metabolic profiles, providing a comprehensive understanding of how oxytocin may help in treating obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled clinical trial of 8-week intranasal oxytocin administration in adults with obesity: Rationale, study design, and methods. Wronski, ML., Plessow, F., Kerem, L., et al.[2023]

Oxytocin (OT) has shown potential as a weight loss therapy by reducing food intake and increasing energy expenditure, effectively overcoming leptin resistance in diet-induced obese models, including rodents and non-human primates.

Chronic intranasal administration of OT has demonstrated promising weight loss effects in obese humans, suggesting it could be a viable therapeutic strategy for obesity without the common side effects associated with current weight loss treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oxytocin as an Anti-obesity Treatment. Niu, J., Tong, J., Blevins, JE.[2022]

Oxytocin (OXT) has been shown to effectively reduce food intake and promote weight loss in various animal models of obesity, including diet-induced and genetically obese mice and rats, without causing adverse effects like visceral illness or cardiovascular issues.

Chronic administration of OXT, both centrally and peripherally, has also demonstrated weight loss in non-human primates and obese humans, suggesting its potential as a safe and effective treatment for obesity, although challenges remain for its long-term use in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of oxytocin in regulation of appetitive behaviour, body weight and glucose homeostasis. Lawson, EA., Olszewski, PK., Weller, A., et al.[2022]

Oxytocin (OXT) has been shown to promote weight loss by reducing energy intake and potentially increasing energy expenditure, with effects varying based on individual characteristics such as obesity status and sex.

In animal studies, OXT supports muscle and bone growth, and in humans, higher levels of circulating OXT are linked to greater lean mass and bone density, suggesting its therapeutic potential for metabolic disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic Effects of Oxytocin. McCormack, SE., Blevins, JE., Lawson, EA.[2022]

Intranasal oxytocin has been studied in 261 children across various trials, primarily focusing on autism spectrum disorder (ASD) and Prader-Willi syndrome (PWS), but results for efficacy in ASD are mixed and there is currently no evidence supporting its benefit for PWS.

Adverse events related to intranasal oxytocin are mostly mild, with few moderate or severe cases reported, indicating a generally safe profile; however, monitoring and reporting of these events are inconsistent, highlighting the need for improved adherence and safety protocols in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of the Safety, Efficacy and Mechanisms of Delivery of Nasal Oxytocin in Children: Therapeutic Potential for Autism and Prader-Willi Syndrome, and Recommendations for Future Research. DeMayo, MM., Song, YJC., Hickie, IB., et al.[2018]

This study is the first double-blind randomized controlled trial examining the side effects of intranasal oxytocin in 100 elementary school-aged children, showing that it is likely safe with no significant side effects reported.

Most side effects were mild and resolved within 24 hours, indicating that intranasal oxytocin is well tolerated in children aged 8-12 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

No side-effects of single intranasal oxytocin administration in middle childhood. Verhees, MWFT., Houben, J., Ceulemans, E., et al.[2019]

Syntocinon(R), a synthetic form of oxytocin, was found to be as effective as natural oxytocin in a study involving 3,342 obstetrical patients.

The use of Syntocinon(R) showed no significant side effects, such as vasospasm or anaphylactic reactions, suggesting it is safe for clinical use in obstetrics when properly indicated and monitored.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synthetic oxytocin. HIBBARD, LT., ANDREWS, AV.[2018]

A systematic review of five randomized controlled trials involving 223 participants found that long-term use of intranasal oxytocin in treating autism spectrum disorder (ASD) is generally well tolerated, with common side effects like nasal discomfort and tiredness not significantly linked to the treatment.

While some severe adverse events were reported, such as aggression and seizures, the overall safety profile suggests that intranasal oxytocin is safe for use in the ASD population, warranting further research to assess its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of reported adverse events of long-term intranasal oxytocin treatment for autism spectrum disorder. Cai, Q., Feng, L., Yap, KZ.[2018]

Oxytocin administration has been shown to effectively reduce body weight and fat mass in various animal models, including leptin-resistant and leptin-deficient subjects, suggesting its potential as a treatment for obesity.

A pilot clinical study indicated that oxytocin may also be effective in treating obesity in humans, but further large-scale studies are needed to confirm its efficacy and explore the underlying molecular mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic Oxytocin Administration as a Treatment Against Impaired Leptin Signaling or Leptin Resistance in Obesity. Altirriba, J., Poher, AL., Rohner-Jeanrenaud, F.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Translational and therapeutic potential of oxytocin as an anti-obesity strategy: Insights from rodents, nonhuman primates and humans. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled clinical trial of 8-week intranasal oxytocin administration in adults with obesity: Rationale, study design, and methods. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Oxytocin as an Anti-obesity Treatment. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The role of oxytocin in regulation of appetitive behaviour, body weight and glucose homeostasis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Metabolic Effects of Oxytocin. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

A Review of the Safety, Efficacy and Mechanisms of Delivery of Nasal Oxytocin in Children: Therapeutic Potential for Autism and Prader-Willi Syndrome, and Recommendations for Future Research. [2018]

7. Germany pubmed.ncbi.nlm.nih.gov

No side-effects of single intranasal oxytocin administration in middle childhood. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Synthetic oxytocin. [2018]

9. Australia pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of reported adverse events of long-term intranasal oxytocin treatment for autism spectrum disorder. [2018]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Chronic Oxytocin Administration as a Treatment Against Impaired Leptin Signaling or Leptin Resistance in Obesity. [2018]