Oxytocin for Weight Loss in Adolescents

• ClinicalTrials.gov Identifier: NCT04551482
• Recruitment Status: Recruiting
• First Posted: September 16, 2020
• Last Update Posted: May 16, 2024
• Sponsor: Massachusetts General Hospital
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Information provided by (Responsible Party): Elizabeth Austen Lawson, Massachusetts General Hospital

Tracking Information

• First Submitted Date: August 31, 2020
• First Posted Date: September 16, 2020
• Last Update Posted Date: May 16, 2024
• Actual Study Start Date: July 28, 2021
• Estimated Primary Completion Date: June 30, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 10, 2020)

• Weight [ Time Frame: 12 weeks ]
  Mean difference in weight between Oxytocin and Placebo group after 12 weeks of treatment
• Height [ Time Frame: Baseline ]
  Measure height on a stadiometer to the nearest 0.1 cm
• Body mass index (BMI) [ Time Frame: 12 weeks ]
  Mean difference in BMI between Oxytocin and Placebo group after 12 weeks of treatment. BMI will be calculated as weight/height2

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 10, 2020)

• Lean mass and Fat mass [ Time Frame: 12 weeks ]
  Dual Energy Absorptiometry (DXA) will be used for measuring fat mass (kg) and lean mass (Kg)
• Fasting Resting Energy Expenditure (kCal) [ Time Frame: 12 weeks ]
  Assessed by Indirect calorimetry

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Oxytocin for Weight Loss in Adolescents
• Official Title: Oxytocin as a Neuroendocrine Therapy for Obesity in Youth
• Brief Summary: 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 (3 sprays 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.

Detailed Description

In recent years there has been a dramatic increase in obesity and its complications in both children and adults. Earlier treatment substantially reduces the likelihood of developing complications later in life while concurrently improving quality of life and decreasing mortality. Therefore, it is essential to develop safe and effective therapeutic strategies for weight loss, particularly in adolescents. Oxytocin (OXT), a hypothalamic peptide hormone that regulates energy balance, is a novel neuroendocrine weight-loss therapeutic in adults with obesity because it simultaneously reduces energy intake and increases energy expenditure and is well-tolerated. Data are currently lacking regarding effects of OXT administration in adolescents with obesity.

The current study is a 12-week randomized controlled trial (RCT) of OXT vs. placebo in 12-18-year old adolescents with obesity. We hypothesize that OXT administration will decrease weight as a consequence of decreased caloric intake and increased energy expenditure, both partially mediated by reduced hypothalamic inflammation (such inflammation drives weight gain by increasing food intake and reducing energy expenditure). Further, OXT will improve metabolic risk markers, such as visceral and intrahepatic fat, systemic inflammation, and serum lipids.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Obesity, Adolescent
• Oxytocin

Intervention

• Drug: Oxytocin nasal spray
  24 IU nasal spray, 4 times per day for 12 weeks
  Other Name: Syntocin
• Drug: Placebo
  24 IU nasal spray, 4 times per day for 12 weeks

Study Arms

• Experimental: Oxytocin
  Oxytocin nasal spray (24 IU nasal spray, 4 times per day for 12 weeks)
  Intervention: Drug: Oxytocin nasal spray
• Placebo Comparator: Placebo
  Placebo nasal spray (24 IU nasal spray, 4 times per day for 12 weeks)
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 10, 2020): 75
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 31, 2027
• Estimated Primary Completion Date: June 30, 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Males and Females, 12-18 years
• Obesity (BMI ≥95th percentile for age and gender)
• Willingness to maintain current diet and lifestyle for the duration of study participation

Exclusion Criteria:

• Active substance abuse
• Use of prescription or over-the-counter drugs or dietary/herbal supplements for the purpose of weight loss. Medications/supplements that may affect weight will be allowed if participants are on a stable dose with stable weight for at least 3 months.
• Greater than 5kg weight loss over 3 months;
• Follows a nonstandard diet (e.g., gluten-free, vegan, Paleo, Atkins, raw diet, macrobiotic diet)
• Cardiovascular disease
• Prolonged QT interval
• Chronic gastrointestinal disorders and other inflammatory conditions
• Epilepsy
• Untreated thyroid disease
• Alanine transaminase (ALT) or aspartate transaminase (AST) >2.5 times upper limit of normal
• Creatinine >1.5 mg/dl
• Hyponatremia
• Pregnancy/breastfeeding or refusal to use contraception not containing estrogen throughout the study if female and sexually active
• MRI exclusion criteria such as the presence of a pacemaker or cerebral aneurysm clips
• Weight >450 lbs due to limits for MRI and DXA scanners
• Type 1 Diabetes Mellitus or Type 2 Diabetes Mellitus if HbA1c >8%
• Active eating disorder

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Elizabeth A Lawson, MD, MMSc; 617-726-3870; ealawson@partners.org

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04551482
• Other Study ID Numbers: 2020P002511; 1R01DK124223-01A1 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Elizabeth Austen Lawson, Massachusetts General Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Massachusetts General Hospital
• Original Study Sponsor: Same as current
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

• Principal Investigator: Elizabeth Lawson, MD, MMSc; Massachusetts General Hospital

• PRS Account: Massachusetts General Hospital
• Verification Date: May 2024