Current partner codePEPTIDESDE
NCT04551482·Phase 2·INTERVENTIONAL

Oxytocin for Weight Loss in Adolescents

Status

Recruiting

Phase

Phase 2

Enrollment

55

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin in youths with obesity, ages 10-18 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.

Full 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 10-18-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.

Interventions

Treatment arms and agents.

DRUG

Oxytocin nasal spray

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

DRUG

Placebo

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

Timeline

From registration to results.

  1. First posted

    Sep 16, 2020

  2. Study start

    Jul 28, 2021

  3. Primary completion

    Dec 31, 2026

  4. Study completion

    Feb 28, 2027

  5. Results posted

    Not reported

  6. Registry updated

    Jun 26, 2026

Outcomes

What the study measures.

Primary outcomes

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

Secondary outcomes

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

Eligibility

Who can take part.

Minimum age
10 Years
Maximum age
18 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Males and Females, 10-18 years * Obesity (BMI ≥95th percentile for age and gender) * Willingness to maintain current diet and lifestyle for the duration of study participation Exclusion Criteria: * Current substance abuse * Use of prescription or over-the-counter drugs or dietary/herbal supplements that may affect weight if dose increased in the three months preceding the baseline visit and/or if they plan to increase the dose during the 18 weeks of study participation. * Greater than 5kg weight loss over 3 months; * Follows a nonstandard diet (e.g., Paleo, Atkins, raw diet, macrobiotic diet) * Cardiovascular disease * Prolonged QT interval * Chronic inflammatory bowel disease and other inflammatory conditions * Epilepsy * TSH \> 2.5 times upper limit of normal * 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

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Massachusetts General Hospital

Boston, Massachusetts, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Oxytocin.

Related PeptideStat pages

Put the record in context.

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