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Adverse event profile of setmelanotide in obesity: an integrated assessment and systematic review using

Kannan Sridharan1, Gowri Sivaramakrishnan2

  • 1Department of Pharmacology & Therapeutics, College of Medicine & Health Sciences, Arabian Gulf University, Manama, Kingdom of Bahrain.

Expert Opinion on Drug Safety
|February 9, 2025
PubMed
Abstract

Insights

Setmelanotide, used for genetic obesity, showed key safety signals including skin hyperpigmentation and injection-site reactions. Ongoing surveillance and patient monitoring are crucial for managing these adverse events.

Area of Science:

  • Pharmacovigilance
  • Clinical Safety Assessment
  • Obesity Therapeutics

Background:

  • Setmelanotide is approved for specific genetic obesity types.
  • Existing data from trials and practice offer limited insight into its adverse event profile.
  • A comprehensive safety assessment is necessary.

Purpose of the Study:

  • To conduct a thorough assessment of setmelanotide's adverse event profile.
  • To analyze reported adverse events from diverse data sources.
  • To identify key safety signals associated with setmelanotide use.

Main Methods:

  • Disproportionality analyses using frequentist and Bayesian methods.
  • Systematic review and meta-analysis of clinical trials and published reports.
  • Inclusion of data from the US FDA Adverse Event Reporting System and case reports.

Main Results:

  • Disproportionality analysis identified skin hyperpigmentation, injection-site reactions, nausea, melanocytic nevus, and ephelides as safety signals.
  • Meta-analysis confirmed high rates of injection-site reactions (96%), skin hyperpigmentation (62%), and nausea (36%).
  • Vomiting (26%) and diarrhea (21%) were also frequently reported, corroborated by individual case reports.

Conclusions:

  • This study offers a detailed overview of setmelanotide's adverse event profile.
  • Highlights the need for careful patient monitoring and ongoing safety surveillance for at least 1.5 years.
  • Suggests further research to refine patient management strategies for setmelanotide therapy.
Keywords:
Melanocortin receptor agonistPharmacovigilanceSetmelanotideanti-obesity drugsobesity

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