Efficacy and Safety of Setmelanotide, a Melanocortin-4 Receptor Agonist, for Obese Patients: A Systematic Review and Meta-Analysis

• Published in: Journal of personalized medicine Vol. 13; no. 10; p. 1460
• Main Authors: Ferraz Barbosa, Bárbara, Aquino de Moraes, Francisco Cezar, Bordignon Barbosa, Camila, Palavicini Santos, Plínio Takashi Karubi, Pereira da Silva, Izael, Araujo Alves da Silva, Bruno, Cristine Marques Barros, Jamile, Rodríguez Burbano, Rommel Mario, Pereira Carneiro dos Santos, Ney, Rodrigues Fernandes, Marianne
• Format: Journal Article
• Language: English
• Published: Basel MDPI AG 01-10-2023; MDPI
• Subjects: Analysis; Blood pressure; Body mass index; Body weight loss; Clinical trials; Collaboration; Confidence intervals; Drug dosages; Hyperpigmentation; Liraglutide; Melanocortin; Melanocortin MC4 receptors; Meta-analysis; Obesity; Patients; Precision medicine; Statistical analysis; Systematic Review; Weight control
• ISSN: 2075-4426; 2075-4426
• DOI: 10.3390/jpm13101460

Background: A malfunction in the melanocortin-4 receptor (MC4R) is associated with obesity in rare genetic syndromes; setmelanotide is a new drug that activates this receptor and is being used to treat severe obesity. This meta-analysis evaluated the efficacy and safety of setmelanotide for weight loss in severe obesity linked to human MC4R deficiency. Methods: We searched PubMed, Embase, and Cochrane for randomized and nonrandomized clinical trials using setmelanotide. We considered a p-value ≤ 0.05 statistically significant. Results: We included 376 patients, of whom 328 (87.2%) received setmelanotide for a mean follow-up of 52 weeks. The mean age was 32.8 (14.67) years. Weight loss was significant (MD −3.52; 95% CI −3.98, −3.05; p = 0.01; I2 = 92%), with an average proportion of −6.91% weight loss during treatment. Changes in BMI showed an MD of −10.55 kg/m2 in patients > 18 years and −0.61 kg/m2 in patients < 18 years (BMI score). However, the drug was associated with a higher risk of skin hyperpigmentation (OR 0.69; 95% CI 0.55, 0.80; p = 0.08). Conclusions: Our results support the use of setmelanotide in treating severe obesity.