Durability and efficacy of solbinsiran, a GalNAc-conjugated siRNA targeting ANGPTL3, in adults with mixed dyslipidaemia (PROLONG-ANG3): a double-blind, randomised, placebo-controlled, phase 2 trial
An erratum to this article was published (Lancet, 3 May 2025 ↗)
Authors' conclusion
Solbinsiran 400 mg reduced apoB in patients with mixed dyslipidaemia and was generally well tolerated.
Study context
- Population
- Adults with mixed dyslipidaemia on moderate- or high-intensity statins (fasting TG 1.69–5.64 mmol/L, LDL-C ≥1.81 mmol/L, non-HDL cholesterol ≥3.36 mmol/L)585 screened
- Participants
- 205 adults
- Comparison
- Solbinsiran 100 mg, 400 mg or 800 mg vs placebo
- Solbinsiran 100 mgn = 30
- Solbinsiran 400 mgn = 58
- Solbinsiran 800 mgn = 59
- Placebon = 58reference
- Primary endpoint
- Percent change in apolipoprotein B (apoB) from baseline, solbinsiran vs placebo (efficacy estimand)
- Follow-up
- Day 180
Methodological detailsdouble-blind, parallel-arm, placebo-controlled, phase 2, 41 clinical research units across seven countries
- Double-blind
- Parallel-arm
- Placebo-controlled
- Phase 2
- 41 clinical research units across seven countries
Primary result
As reported in the abstract
Placebo-adjusted percent change in apoB
Each group vs placeboPlacebo-adjusted percent change, % (95% CI)P value
Solbinsiran 100 mg
−2.8(−15.5 to 11.9)
P = 0.69Solbinsiran 400 mg
−14.3(−23.6 to −3.9)
P = 0.0085Solbinsiran 800 mg
−8.3(−18.3 to 2.9)
P = 0.14Safety
Treatment-emergent adverse events
- Treatment-emergent adverse events: placebo denominator 57
Original publication
Durability and efficacy of solbinsiran, a GalNAc-conjugated siRNA targeting ANGPTL3, in adults with mixed dyslipidaemia (PROLONG-ANG3): a double-blind, randomised, placebo-controlled, phase 2 trial. Lancet. Published 31 March 2025. doi:10.
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