Setmelanotide for the Treatment of Acquired Hypothalamic Obesity
Authors' conclusion
Setmelanotide led to significantly greater reductions in BMI and hunger than placebo at 52 weeks among participants 4 to 66 years of age with acquired hypothalamic obesity.
Study context
- Population
- Persons ≥4 years with acquired hypothalamic obesity (body-mass index (BMI) ≥95th percentile for age and sex if <18 years, or ≥30 if ≥18 years, and history of hypothalamic tumor, lesion or injury); mean age 19.9±13.8 years (range 4 to 66)randomized 2:1
- Participants
- 120 persons
- Comparison
- Setmelanotide vs placebo, subcutaneously once daily for 52 weeks
- Setmelanotiden = 81
- Placebon = 39reference
- Primary endpoint
- Mean percent change in BMI from baseline
- Follow-up
- 52 weeks after end of dose escalation
Methodological detailsphase 3, placebo-controlled
- Phase 3
- Placebo-controlled
Primary result
As reported in the abstract
Least-squares mean (LSM) change in BMI · 52 weeks
Setmelanotide
−16.5
least-squares mean · 95% CI −19.3–-13.8 · %
Placebo
3.3
least-squares mean · 95% CI −0.6–7.2 · %
P < 0.001
Secondary outcomes
Least-squares mean
| Outcome | Setmelanotide | Placebo | P value |
|---|---|---|---|
| LSM change in weekly average of maximal daily hunger score (0–10), participants ≥12 years · 52 weeks | −2.73 (95% CI −3.28–-2.18) | −1.45 (95% CI −2.23–-0.67) | P = 0.009 |
Safety
Adverse events
Serious adverse events
Adverse events
- Most common adverse events with setmelanotide: skin hyperpigmentation, nausea, vomiting, headache
Original publication
Setmelanotide for the Treatment of Acquired Hypothalamic Obesity. N Engl J Med. Published 9 July 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →