NewAmsterdam extends obicetrapib's cardiovascular data into an Alzheimer's biomarker signal
Posters at AAIC 2026 build on BROADWAY's prespecified p-tau217 finding, testing whether a CETP inhibitor built for cholesterol has a case in Alzheimer's prevention.
Executive Summary
- NewAmsterdam is presenting a prespecified biomarker analysis from its completed cardiovascular trial, showing an Alzheimer's-related plasma marker moved with obicetrapib treatment.
- The clearest effect concentrated in patients carrying two copies of a gene variant linked to higher Alzheimer's risk, a subgroup that is also the smallest and least representative of the trial's core cardiovascular population.
- The underlying trial was built and powered to measure cholesterol lowering, not cognitive or clinical Alzheimer's outcomes, so the biomarker finding cannot speak to whether the drug changes disease course.
- Obicetrapib remains the only CETP inhibitor with completed Phase 3 data in this cardiovascular population, and no competing CETP program has moved into Alzheimer's biomarker territory.
The presentation
NewAmsterdam Pharma Company N.V. is scheduled to deliver an oral presentation and three posters at AAIC 2026 in London, covering plasma biomarker findings from BROADWAY, its completed Phase 3 trial of obicetrapib (NCT05142722). The posters, including "Undiagnosed Alzheimer's Pathology in Cardiovascular Patients" and "ApoE4-Dependent Dose Response to CETP Inhibition," are scheduled for July 14 and 15, 2026. BROADWAY enrolled 2,530 patients with heterozygous familial hypercholesterolemia and/or established atherosclerotic cardiovascular disease and completed in September 2024, with results first posted to ClinicalTrials.gov in September 2025. NewAmsterdam+1NewAmsterdam Pharma Announces Upcoming Presentations at the Alzheimer's Association ...Jul 1, 2026Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying TherapiesNCT05142722
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
The design behind the biomarker read
The Alzheimer's analysis is a prespecified plasma biomarker substudy layered onto a trial whose registered primary endpoint was percent change in LDL-C from baseline to Day 84, measured against placebo. The substudy assessed 1,535 of the 2,530 randomized patients over 12 months of therapy, including 367 participants whose ApoE genotype could be determined, 29 of whom carried two copies of the ApoE4 variant associated with elevated Alzheimer's risk. Because the substudy draws from a population selected for cardiovascular risk rather than balanced for baseline Alzheimer's risk factors, the comparison between treatment and placebo arms was not adjusted for those differences. NCT05142722+1Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying TherapiesNCT05142722NewAmsterdam Pharma Announces Upcoming Presentations at the Alzheimer's Association ...Jul 1, 2026
The biomarker result
The analysis found statistically significant reductions in plasma p-tau217, a biomarker associated with Alzheimer's pathology, across the full analysis set and among ApoE4 carriers at 12 months, with a 20.5% reduction observed in the 29 ApoE4/E4 homozygous carriers. That subgroup is the population in which CETP inhibition's biomarker effect looked strongest, and it is also the smallest slice of the substudy, a raw count too small to generalize as a rate. NewAmsterdamNewAmsterdam Pharma Announces Upcoming Presentations at the Alzheimer's Association ...Jul 1, 2026
The competitive frame
Obicetrapib is the only CETP inhibitor with completed Phase 3 data in the HeFH/ASCVD population and the only Phase 3 asset registered for CETP in that indication; the nearest mechanism precedent, dalcetrapib, is in Phase 3 for acute coronary syndrome under a different sponsor, DalCor Pharmaceuticals. No other CETP program has extended into Alzheimer's biomarker analysis, so the readthrough sits outside any established competitive field for this specific application of the mechanism. NewAmsterdam's broader obicetrapib portfolio includes the completed BROOKLYN and BROADWAY trials, the ongoing PREVAIL cardiovascular outcomes trial that finished enrolling over 9,500 patients in April 2024, and Menarini's Phase 3 program in non-familial hypercholesterolemia under a European licensing agreement. NewAmsterdamNewAmsterdam Pharma Announces Upcoming Presentations at the Alzheimer's Association ...Jul 1, 2026
What the trial's own registry shows
BROADWAY's primary completion date moved four times over the life of the trial, from a December 2022 estimate to a final September 26, 2024 date, and its enrollment target rose from an initial 1,200 to a final 2,530 as the trial expanded. The trial completed on schedule against its most recent guidance and posted results within roughly a year of completion, consistent with normal registrational-trial conduct for a program that reached its enrollment target. NCT05142722Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying TherapiesNCT05142722
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