NCT04516291

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

A Phase 2b Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging Study to Assess the Efficacy, Safety, and Tolerability of Vupanorsen (PF-07285557) in Statin-Treated Participants With Dyslipidemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 286 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This study is intended to enable selection of a dose(s) for future development of vupanorsen for cardiovascular (CV) risk reduction and hypertriglyceridemia.

Conditions

• Dyslipidemias
• Hyperlipidemias
• Hyperlipoproteinemias

Interventions

Type	Name	Description
DRUG	Vupanorsen	Vupanorsen and placebo will be provided as prefilled syringes packaged and dispensed in cartons with tamper-evident seals. Only single-use syringes will be used.
DRUG	Placebo	Vupanorsen and placebo will be provided as prefilled syringes packaged and dispensed in cartons with tamper-evident seals. Only single-use syringes will be used.

Timeline

• Start date: 2020-09-28
• Primary completion: 2021-09-29
• Completion: 2021-12-06
• First posted: 2020-08-18
• Last updated: 2022-10-04
• Results posted: 2022-10-04

Locations

114 sites across 3 countries: United States, Canada, Poland

Regulatory

• FDA-regulated drug study