Regulatory 6 items

Trials, agents, guidance

• Agent ObicetrapibPhase 3 complete for LDL-C; positive CHMP opinion 24 July 2026; EC decision due H2 2026; PREVAIL outcomes trial ongoing
• Trial Menarini European phase 3 (NCT07614958)Recruiting; primary completion January 2027

Studies

• Only 42% of 96,944 CETP-inhibitor trial subjects ever appeared in a published report, a case study in biomarker-driven drug development finds (Circ Cardiovasc Qual Outcomes 2017)Circ Cardiovasc Qual Outcomes · June 2017 6
• A regulatory perspective argues the termination of torcetrapib means future HDL therapies will need preapproval proof of effects on actual disease progression (Am J Cardiol 2007)Am J Cardiol · August 2007 4

Timeline

• European Commission decision expected15 October 2026
• CHMP recommends Ubeslo and Evlarco24 July 2026