The Effects of Oxytocin in Obese Adults

NCT03043053 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 2016P002810
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

weight loss; body mass index; oxytocin; magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 8 weeks

Secondary Outcomes (3)

• Change in Resting Energy Expenditure After 8 Weeks of Oxytocin Versus Placebo

  Baseline to 8 weeks

• Change in Fat Depots After 8 Weeks of Oxytocin Versus Placebo

  Baseline to 8 weeks

• Difference in Caloric Intake After 6 Weeks of Oxytocin Versus Placebo

  Baseline to 6 weeks

Study Arms (2)

oxytocin

EXPERIMENTAL

oxytocin nasal spray (24 IU nasal spray, 4 times per day for 8 weeks)

Drug: oxytocin nasal spray

placebo

PLACEBO COMPARATOR

placebo nasal spray (4 times per day for 8 weeks)

Drug: Placebo

Interventions

oxytocin nasal spray DRUG

oxytocin intranasal spray

Also known as: Syntocinon

oxytocin

Placebo DRUG

Placebo nasal spray

placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old;
• BMI greater than or equal to 30 kg/m2

You may not qualify if:

• 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% ;
• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Plessow 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.

  PMID: 38815173 DERIVED

MeSH Terms

Conditions

Obesity; Weight Loss

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Elizabeth A. Lawson, MD, MMSc
• Organization: Massachusetts General Hospital

ealawson@mgh.harvard.edu

617-726-3870

Study Officials

• Elizabeth A Lawson, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine, Harvard Medical School

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 3, 2017
• Study Start: July 1, 2017
• Primary Completion: May 20, 2022
• Study Completion: July 7, 2022
• Last Updated: February 7, 2024
• Results First Posted: February 7, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)