Drug updated on 10/28/2024
| Dosage Form | Injection (subcutaneous; 10 mg/mL) |
| Drug Class | Melanocortin 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).
Latest News
Summary
- This summary is based on the review of one systematic review(s)/meta-analysis(es). [1]
- Setmelanotide demonstrated a significant reduction in weight, with a mean difference of -3.52 (95% CI (confidence interval) -3.98, -3.05) and an average weight loss of -6.91% in patients with severe obesity linked to MC4R deficiency.
- There was a marked decrease in 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 Title | Year | Source |
|---|---|---|
| Imcivree (setmelanotide) Prescribing Information. | 2022 | Rhythm Pharmaceuticals Inc., Boston, MA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Efficacy and Safety of Setmelanotide, a Melanocortin-4 Receptor Agonist, for Obese Patients: A Systematic Review and Meta-Analysis | 2023 | Journal of Personalized Medicine |