NewAmsterdam Pharma Company N.V. announced on September 29, 2026, that it has dosed the first participant in the SPINOZA clinical trial. The study is a Phase 2b, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of obicetrapib in individuals with preclinical Alzheimer's disease.
The trial will enroll approximately 400 participants. Eligible individuals must have biomarker evidence of early Alzheimer's disease pathology and carry specific ApoE genotypes, including ApoE4/E4, ApoE3/E4, or ApoE3/E3. Participants will be randomized 1:1 to receive obicetrapib 10 mg or placebo for 52 weeks.
The primary efficacy endpoint of the study is the change from baseline to Week 52 in plasma phosphorylated tau 217 (p-tau217), a biomarker associated with Alzheimer's disease pathology. Secondary endpoints include changes in other plasma Alzheimer's disease biomarkers, such as Aβ42/Aβ40 and p-tau217/Aβ42, as well as changes in the Preclinical Alzheimer's Cognitive Composite 5 (PACC5) score.
Following the 52-week double-blind treatment period, participants may enter a 26-week open-label extension study where all participants will receive obicetrapib. The trial design was informed by findings from a pre-specified Alzheimer's disease biomarker analysis in the Company's Phase 3 BROADWAY trial, which demonstrated statistically significant lower absolute changes in p-tau217 compared to placebo over 12 months in both the full analysis set and ApoE4 carriers.
Obicetrapib is a novel, oral, low-dose CETP inhibitor developed by NewAmsterdam. The Company is advancing obicetrapib alongside its ongoing Phase 3 REMBRANDT, RUBENS, and PREVAIL clinical trials. The Company also noted that it has completed enrollment of the Phase 3 PREVAIL cardiovascular outcomes trial, which randomized over 9,500 patients.
