{"doi":"10.1210/jendso/bvad037","title":"A Pilot Randomized Clinical Trial of Intranasal Oxytocin to Promote Weight Loss in Individuals With Hypothalamic Obesity","abstract":"Context: Hypothalamic obesity is a rare, treatment-resistant form of obesity. In preliminary studies, the hypothalamic hormone oxytocin (OXT) has shown promise as a potential weight loss therapy. Objective: To determine whether 8 weeks of intranasal OXT (vs 8 weeks of placebo) promotes weight loss in children, adolescents, and young adults with hypothalamic obesity. Methods: This randomized, double-blind, placebo-controlled, crossover pilot trial (NCT02849743), conducted at an outpatient academic medical center, included patients aged 10 to 35 years with hypothalamic obesity from hypothalamic/pituitary tumors. Participants received intranasal OXT (Syntocinon, 40 USP units/mL, 4 IU/spray) vs excipient-matched placebo, 16 to 24 IU 3 times daily at mealtimes. Weight loss attributable to OXT vs placebo and safety (adverse events) were assessed. Results: Of 13 individuals randomized (54% female, 31% pre-pubertal, median age 15.3 years, IQR 13.3-20.6), 10 completed the entire study. We observed a nonsignificant within-subject weight change of -0.6 kg (95% CI: -2.7, 1.5) attributable to OXT vs placebo. A subset (2/18 screened, 5/13 randomized) had prolonged QTc interval on electrocardiography prior to screening and/or in both treatment conditions. Overall, OXT was well-tolerated, and adverse events (epistaxis and nasal irritation, headache, nausea/vomiting, and changes in heart rate, blood pressure, and QTc interval) were similar between OXT and placebo. In exploratory analyses, benefits of OXT for anxiety and impulsivity were observed. Conclusion: In this pilot study in hypothalamic obesity, we did not detect a significant impact of intranasal OXT on body weight. OXT was well-tolerated, so future larger studies could examine different dosing, combination therapies, and potential psychosocial benefits.","journal":"Journal of the Endocrine Society","year":2023,"id":323908,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":35,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9466,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2023-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1039287,"name":"Zi Wang","orcid":"0000-0002-2890-3944","position":1,"is_corresponding":false},{"id":762472,"name":"Kristin Wade","orcid":null,"position":2,"is_corresponding":false},{"id":762471,"name":"Anna Dedio","orcid":null,"position":3,"is_corresponding":false},{"id":959732,"name":"Nicolette Cilenti","orcid":"0009-0004-2158-5906","position":4,"is_corresponding":false},{"id":1039288,"name":"Julia Crowley","orcid":"0000-0002-4839-7022","position":5,"is_corresponding":false},{"id":673785,"name":"Franziska Plessow","orcid":"0000-0002-9721-7817","position":6,"is_corresponding":false},{"id":739736,"name":"Vaneeta Bamba","orcid":"0000-0003-4747-6949","position":7,"is_corresponding":false},{"id":431638,"name":"Jeffrey D. Roizen","orcid":"0000-0002-3384-6200","position":8,"is_corresponding":false},{"id":1039289,"name":"Yaoguang Jiang","orcid":"0000-0002-4354-3019","position":9,"is_corresponding":false},{"id":1039740,"name":"Jack Stylli","orcid":null,"position":10,"is_corresponding":false},{"id":316435,"name":"Arjun Ramakrishnan","orcid":"0000-0002-4622-4873","position":11,"is_corresponding":false},{"id":246475,"name":"Michael L. Platt","orcid":"0000-0003-3912-8821","position":12,"is_corresponding":false},{"id":1039290,"name":"Karuna Shekdar","orcid":"0000-0002-2609-1567","position":13,"is_corresponding":false},{"id":109184,"name":"Michael J. Fisher","orcid":"0000-0003-3408-3839","position":14,"is_corresponding":false},{"id":1039291,"name":"Victoria L. Vetter","orcid":"0000-0002-1937-5262","position":15,"is_corresponding":false},{"id":735399,"name":"Matthew C. 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