Randomized Study of Obicetrapib as an Adjunct to Statin Therapy

Summary

This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to high-intensity statin therapy.

Timeline

Start

2021-02-18

Primary completion

2021-05-24

Completion

2021-08-30

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs Obicetrapib 5 mg; p <.0001; Least Squares (LS) Means -32.96 (95% CI -44.03 to -21.90); Mixed Models Analysis NCT04753606 ↗

registry analysis (superiority test); Placebo vs Obicetrapib 10 mg; p <.0001; Least Squares (LS) Means -39.18 (95% CI -50.21 to -28.15); Mixed Models Analysis NCT04753606 ↗

paper obicetrapib resulted in a significant decrease as compared with placebo in median LDL-C concentration (by up to 51%; P < 0.0001), the primary trial outcome. PMID 35953719 ↗

Publications

• Results Nicholls SJ, Ditmarsch M, Kastelein JJ, Rigby SP, Kling D, Curcio DL, Alp NJ, Davidson MH. Lipid lowering effects of the CETP inhibitor obicetrapib in combination with high-intensity statins: a randomized phase 2 trial. Nat Med. 2022 Aug;28(8):1672-1678. doi: 10.1038/s41591-022-01936-7. Epub 2022 Aug 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Obicetrapib	Small molecule	5 mg	—
Subject	Obicetrapib	Small molecule	10 mg	—

Indications