Impact of Setmelanotide on Metabolic Syndrome Risk in Patients With Bardet-Biedl Syndrome
Authors' conclusion
MetS-Z-BMI score reductions were observed after 52 weeks of treatment, suggesting that setmelanotide may decrease metabolic syndrome severity and risk of future obesity-related comorbidities in those with BBS.
Study context
- Population
- Patients with Bardet-Biedl syndrome treated with setmelanotide in a phase 3 study, with data for MetS-Z-BMI calculation22 evaluable
- Participants
- 32 patients
- Comparison
- MetS-Z-BMI score change with setmelanotide, baseline to week 52
- Primary endpoint
- Mean MetS-Z-BMI score
- Follow-up
- Baseline and Week 52
Methodological detailssingle-group, subgroup analyses by sex, age, genotype and response
- Single-group
- Subgroup analyses by sex, age, genotype and response
Primary result
As reported in the abstract
Change in MetS-Z-BMI score, overall · Week 52
Mean (SD) MetS-Z-BMI score reduced by
0.34
0.62
Baseline mean (SD) MetS-Z-BMI score
1.1
0.5
Further findings
Mean
| Outcome | Achievers | Nonachievers | P value |
|---|---|---|---|
| MetS-Z-BMI score change by achievement of weight-based threshold · Week 52 | −0.64 (SD 0.54) | 0.08 (SD 0.47) | P = 0.0043 |
Other subgroup comparisons (sex, age, genotype)
- No significant difference with other subgroup comparisons
Baseline mean (SD) OR of future CVD or T2D
- Adults, CVD
- 3.1 (1.5)
- Adults, T2D
- 3.7 (1.7)
- Pediatric, CVD
- 10.2 (4.7)
- Pediatric, T2D
- 2.8 (1.3)
Original publication
Impact of Setmelanotide on Metabolic Syndrome Risk in Patients With Bardet-Biedl Syndrome. J Clin Endocrinol Metab. Published 7 February 2025. doi:10.
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