BROADWAY
Trial question
What is the effect of obicetrapid, a cholesterylester transfer protein inhibitor, in patients with ASCVD or heterozygous familial hypercholesterolemia?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
34.0% female
66.0% male
N = 2530
2530 patients (853 female, 1677 male).
Inclusion criteria: adult patients with ASCVD or heterozygous familial hypercholesterolemia.
Key exclusion criteria: NYHA class III or IV HF or LVEF < 30%; hospitalized for HF within 5 years; major adverse cardiac event within 3 months; uncontrolled severe hypertension; homozygous familial hypercholesterolemia; active liver disease.
Interventions
N=1686 obicetrapid (at a dose of 10 mg daily for 365 days).
N=844 placebo (matching placebo daily for 365 days).
Primary outcome
Reduction in low-density lipoprotein cholesterol level at day 84
29.9%
-2.7%
29.9 %
22.4 %
14.9 %
7.5 %
0.0 %
-7.5 %
Obicetrapid
Placebo
Significant
increase ▲
NNT = 3
Significantly greater reduction in LDL-C level at day 84 (29.9% vs. -2.7%; MD 32.6, 95% CI 29.5 to 35.8).
Secondary outcomes
Significantly greater reduction in LDL-C level at day 365 (25.3% vs. 1.3%; MD 24, 95% CI 20.1 to 27.9).
Significantly greater reduction in ApoB at day 365 (15.6% vs. 1.8%; MD 13.8, 95% CI 11.4 to 16.2).
Significantly greater improvement in HDL-C level at day 365 (125.4% vs. 3.4%; MD 122, 95% CI 117.5 to 126.6).
Safety outcomes
No significant difference in adverse events.
Conclusion
In adult patients with ASCVD or heterozygous familial hypercholesterolemia, obicetrapid was superior to placebo with respect to reduction in LDL-C level at day 84.
Reference
Stephen J Nicholls, Adam J Nelson, Marc Ditmarsch et al. Safety and Efficacy of Obicetrapib in Patients at High Cardiovascular Risk. N Engl J Med. 2025 May 7. Online ahead of print.
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