CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 286 enrolled
Drug / intervention
Vupanorsen +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04516291
NCT04516291Phase 2Completed
CompareCT.gov

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

Pfizer·interventional·Posted Aug 18, 2020·Updated Oct 4, 2022

In Brief

A Phase 2 clinical trial evaluating Vupanorsen and Placebo for Dyslipidemias and 2 related conditions. Completed, enrolled 286 participants across 114 sites in 3 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDyslipidemias, Hyperlipidemias, Hyperlipoproteinemias
CountriesCanada, Poland, United States
CollaboratorsThe TIMI Study Group

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedAug 18, 2020
Enrollment StartSep 28, 2020
Primary CompletionSep 29, 2021
Study CompletionDec 6, 2021
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 5.9 years ago

Interventions

Vupanorsendrug

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.

Placebodrug

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.