A Dose-Ranging Study With Vupanorsen (TRANSLATE-TIMI 70)

Summary

This is a multicenter, Phase 2b, double-blind, placebo-controlled, parallel group study to provide data on efficacy, safety, tolerability, and pharmacokinetics (PK) of PF-07285557 (hereafter, vupanorsen) administered subcutaneously (SC) at various doses and regimens in participants with dyslipidemia, defined in this study as participants with elevated non-HDL-C and TG who are receiving a stable dose of a statin. This study is also known as TaRgeting ANGPTL3 with an aNtiSense oLigonucleotide in AdulTs with dyslipidEmia (TRANSLATE-TIMI 70).

Timeline

Start

2020-09-28

Primary completion

2021-09-29

Completion

2021-12-06

Outcome

Met primary endpoint

registry Placebo vs Vupanorsen: 80 mg Q4W; p <0.001; Least Square (LS) Mean difference -22.4 (95% CI -32.1 to -12.7) NCT04516291 ↗

paper Vupanorsen resulted in significant decreases from baseline over placebo in non-HDL-C PMID 35369705 ↗

release “In the dose-ranging study in subjects with elevated non-HDL-C and triglycerides (TG), the study met its primary endpoint, achieving a statistically significant reduction in non-HDL-C” ionis.com ↗

Publications

• Bergmark BA, Marston NA, Bramson CR, Curto M, Ramos V, Jevne A, Kuder JF, Park JG, Murphy SA, Verma S, Wojakowski W, Terra SG, Sabatine MS, Wiviott SD; TRANSLATE-TIMI 70 Investigators. Effect of Vupanorsen on Non-High-Density Lipoprotein Cholesterol Levels in Statin-Treated Patients With Elevated Cholesterol: TRANSLATE-TIMI 70. Circulation. 2022 May 3;145(18):1377-1386. doi: 10.1161/CIRCULATIONAHA.122.059266. Epub 2022 Apr 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vupanorsen	Unknown	60 mg	Subcutaneous
Subject	Vupanorsen	Unknown	80 mg	Subcutaneous
Subject	Vupanorsen	Unknown	120 mg	Subcutaneous
Subject	Vupanorsen	Unknown	160 mg	Subcutaneous

Indications