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Effect of bremelanotide on body weight of obese women: Data from two phase 1 randomized controlled trials
AIMS: The melanocortin 4 receptor (MC4R) plays a central role in appetite regulation, and agonistic activity at this receptor promotes satiety. Results from two randomized controlled clinical trials examine the effects of bremelanotide's agonism at MC4R on caloric intake and body weight. METHOD...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Blackwell Publishing Ltd
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9314948/ https://www.ncbi.nlm.nih.gov/pubmed/35170192 http://dx.doi.org/10.1111/dom.14672 |
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author | Spana, Carl Jordan, Robert Fischkoff, Steven |
author_facet | Spana, Carl Jordan, Robert Fischkoff, Steven |
author_sort | Spana, Carl |
collection | PubMed |
description | AIMS: The melanocortin 4 receptor (MC4R) plays a central role in appetite regulation, and agonistic activity at this receptor promotes satiety. Results from two randomized controlled clinical trials examine the effects of bremelanotide's agonism at MC4R on caloric intake and body weight. METHODS: Premenopausal women with a body mass index >30 kg/m(2) were studied in two phase 1, single‐centre, randomized, double‐blind, placebo‐controlled trials. Study A matched subjects 1:1 to receive subcutaneous placebo or bremelanotide three times daily for days 1‐15. Study B was a crossover trial with six distinct treatment sequences consisting of three 4‐day treatment periods, investigating once‐a‐day and twice‐a‐day exposure to bremelanotide versus placebo. Subjects received one of the three treatments twice‐daily during each period: 0 mg/0 mg, 2.5 mg/0 mg or 2.5 mg/2.0 mg bremelanotide. Body weight and food intake were recorded in detail daily. Adverse events were recorded throughout both studies. RESULTS: In Study A, 27 of 30 bremelanotide subjects (90.0%) completed the trial and exhibited a significantly greater reduction in body weight after 16 days versus placebo [least squares mean difference (95% CI), −1.3 (−1.9 to −0.8) kg; p < .0001]. Mean caloric intake in bremelanotide subjects was decreased versus placebo, with a magnitude of reduction of approximately 400 kcal/day throughout Study A (p < .01). In Study B, 15 of 27 subjects (55.6%) completed all three phases. Significantly greater reduction of mean body weight occurred in twice‐daily bremelanotide subjects versus placebo (1.7 vs. 0.9 kg, respectively, p < .001). Total caloric intake reduction was significantly greater in the bremelanotide groups versus placebo (mean difference range: 398‐469 kcal; p < .0001). CONCLUSIONS: Agonist activity at the MC4R may aid in reducing caloric intake and weight loss in obese women. |
format | Online Article Text |
id | pubmed-9314948 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Blackwell Publishing Ltd |
record_format | MEDLINE/PubMed |
spelling | pubmed-93149482022-07-30 Effect of bremelanotide on body weight of obese women: Data from two phase 1 randomized controlled trials Spana, Carl Jordan, Robert Fischkoff, Steven Diabetes Obes Metab Original Articles AIMS: The melanocortin 4 receptor (MC4R) plays a central role in appetite regulation, and agonistic activity at this receptor promotes satiety. Results from two randomized controlled clinical trials examine the effects of bremelanotide's agonism at MC4R on caloric intake and body weight. METHODS: Premenopausal women with a body mass index >30 kg/m(2) were studied in two phase 1, single‐centre, randomized, double‐blind, placebo‐controlled trials. Study A matched subjects 1:1 to receive subcutaneous placebo or bremelanotide three times daily for days 1‐15. Study B was a crossover trial with six distinct treatment sequences consisting of three 4‐day treatment periods, investigating once‐a‐day and twice‐a‐day exposure to bremelanotide versus placebo. Subjects received one of the three treatments twice‐daily during each period: 0 mg/0 mg, 2.5 mg/0 mg or 2.5 mg/2.0 mg bremelanotide. Body weight and food intake were recorded in detail daily. Adverse events were recorded throughout both studies. RESULTS: In Study A, 27 of 30 bremelanotide subjects (90.0%) completed the trial and exhibited a significantly greater reduction in body weight after 16 days versus placebo [least squares mean difference (95% CI), −1.3 (−1.9 to −0.8) kg; p < .0001]. Mean caloric intake in bremelanotide subjects was decreased versus placebo, with a magnitude of reduction of approximately 400 kcal/day throughout Study A (p < .01). In Study B, 15 of 27 subjects (55.6%) completed all three phases. Significantly greater reduction of mean body weight occurred in twice‐daily bremelanotide subjects versus placebo (1.7 vs. 0.9 kg, respectively, p < .001). Total caloric intake reduction was significantly greater in the bremelanotide groups versus placebo (mean difference range: 398‐469 kcal; p < .0001). CONCLUSIONS: Agonist activity at the MC4R may aid in reducing caloric intake and weight loss in obese women. Blackwell Publishing Ltd 2022-03-15 2022-06 /pmc/articles/PMC9314948/ /pubmed/35170192 http://dx.doi.org/10.1111/dom.14672 Text en © 2022 Palatin Technologies, Inc. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Original Articles Spana, Carl Jordan, Robert Fischkoff, Steven Effect of bremelanotide on body weight of obese women: Data from two phase 1 randomized controlled trials |
title | Effect of bremelanotide on body weight of obese women: Data from two phase 1 randomized controlled trials |
title_full | Effect of bremelanotide on body weight of obese women: Data from two phase 1 randomized controlled trials |
title_fullStr | Effect of bremelanotide on body weight of obese women: Data from two phase 1 randomized controlled trials |
title_full_unstemmed | Effect of bremelanotide on body weight of obese women: Data from two phase 1 randomized controlled trials |
title_short | Effect of bremelanotide on body weight of obese women: Data from two phase 1 randomized controlled trials |
title_sort | effect of bremelanotide on body weight of obese women: data from two phase 1 randomized controlled trials |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9314948/ https://www.ncbi.nlm.nih.gov/pubmed/35170192 http://dx.doi.org/10.1111/dom.14672 |
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