Setmelanotide

(Imcivree®)

Setmelanotide

Drug updated on 12/11/2024

Dosage FormInjection (subcutaneous; 10 mg/mL)
Drug ClassMelanocortin 4 (MC4) receptor agonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity due to Pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency as determined by an FDA-approved test demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS)
  • Indicated for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity due to Bardet-Biedl syndrome (BBS).

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Summary
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  • This summary is based on the review of one systematic review/meta-analysis. [1]
  • Setmelanotide demonstrated a significant reduction in weight, with a mean difference of -3.52 (95% confidence interval (CI) -3.98, -3.05) and an average weight loss of -6.91% in patients with severe obesity linked to melanocortin 4 receptor (MC4R) deficiency.
  • There was a marked decrease in body mass index (BMI), particularly in adults (>18 years), with a mean reduction of -10.55 kg/m², while children (<18 years) saw a smaller BMI decrease of -0.61 kg/m².
  • Skin hyperpigmentation was observed as a potential adverse effect, with an odds ratio of 0.69 (95% CI 0.55, 0.80), though it did not reach statistical significance (p = 0.08).
  • There were no other significant adverse safety outcomes highlighted in the reviewed studies.
  • Setmelanotide demonstrated a more significant reduction in BMI in adults (>18 years old) with a mean difference of -10.55 kg/m² compared to children (<18 years old) with a smaller BMI reduction of -0.61 kg/m², indicating that the drug may be more effective in adults. There is no further information on specific subgroups.

Product Monograph / Prescribing Information

Document TitleYearSource
Imcivree (setmelanotide) Prescribing Information.2022Rhythm Pharmaceuticals Inc., Boston, MA

Systematic Reviews / Meta-Analyses