Obicetrapib showed no glycaemic worsening in pooled phase 3 analysis

Researchers pooled individual participant data from the phase 3 BROADWAY and BROOKLYN trials, including 1,700 participants without diabetes at baseline: 899 with normal glycaemia and 801 with prediabetes. Participants were randomised 2:1 to obicetrapib 10 mg or placebo for 52 weeks. The analysis assessed changes in glycaemia and new-onset diabetes (NoD). The authors also conducted a systematic review and meta-analysis of six eligible CETP-inhibitor trials reporting NoD.

At week 52, the HbA1c difference between obicetrapib and placebo was −0.02% (least-squares mean difference; 95% CI −0.04 to 0.00). NoD occurred in 6.4% of participants receiving obicetrapib and 8.5% receiving placebo; the adjusted odds ratio was 0.69 (95% CI 0.47–1.03). The pooled class estimate indicated a 16% lower NoD risk with CETP inhibition (risk ratio 0.84, 95% CI 0.79–0.90; I²=0%).

The findings do not indicate glycaemic worsening over 52 weeks, but the obicetrapib estimate for NoD was not statistically conclusive. The authors note that the larger, longer PREVAIL trial will provide further evidence. The results alone do not establish a clinical practice change.