# Oxytocin as a Neuroendocrine Therapy for Obesity in Youth

> **NIH NIH R01** · MASSACHUSETTS GENERAL HOSPITAL · 2024 · $692,474

## Abstract

PROJECT ABSTRACT
Obesity in adolescence and young adulthood is epidemic, leading to increased metabolic risk later in life. The
extent of weight loss through lifestyle interventions is variable and difficult to sustain. Existing medical
therapies for adults, which are often not FDA-approved in children, may lead to modest weight loss, but effects
are difficult to sustain, and these medications are limited by their tolerability. Oxytocin (OXT), a hypothalamic
hormone that regulates food intake and energy metabolism, is an exciting potential novel therapeutic in this
population. Intranasal (IN) OXT induced marked weight loss and was well tolerated in a small 8-week study of
adults with obesity. Our preliminary data show reduction in BMI SDS with excellent tolerability with 6-months of
IN OXT in 5-18-year-old children across a range of BMIs. Data in rodent and nonhuman primates indicate that
OXT drives weight loss by reducing food consumption and increasing energy expenditure. Importantly, OXT
also has the potential to reduce metabolic risk through reduction in visceral and hepatic fat, reduced
inflammation, and improved lipids. In fact, OXT has recently been shown to reduce neuroinflammation, and
hypothalamic inflammation in rodent models with obesity. We propose a randomized, placebo-controlled study
of twelve weeks of IN OXT vs. placebo to determine whether OXT reduces weight and metabolic risk markers
in adolescents with obesity as it does in diet-induced obese animal models. We will also investigate underlying
mechanisms driving OXT effects using cutting-edge imaging and metabolic assessments. In a study of 75
adolescents with obesity, we hypothesize that twelve weeks of IN OXT compared to placebo will result in (1)
reduced BMI SDS from (a) decreased food intake in the fasting state and in the absence of hunger, and (b)
increased resting energy expenditure and diet-induced thermogenesis, mediated by reduced measures of
hypothalamic inflammation; and (2) reduced visceral and intrahepatic fat with relative preservation of
lean/muscle mass, associated with reduced systemic inflammation and an improved lipid profile. This study will
be the first to systematically investigate the efficacy and safety of OXT as a novel therapeutic agent to induce
weight loss and improve indicators of metabolic risk in adolescents with obesity.

## Key facts

- **NIH application ID:** 10878668
- **Project number:** 5R01DK124223-04
- **Recipient organization:** MASSACHUSETTS GENERAL HOSPITAL
- **Principal Investigator:** Miriam Antoinette Bredella
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $692,474
- **Award type:** 5
- **Project period:** 2020-09-17 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10878668

## Citation

> US National Institutes of Health, RePORTER application 10878668, Oxytocin as a Neuroendocrine Therapy for Obesity in Youth (5R01DK124223-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10878668. Licensed CC0.

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