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Vupanorsen

Phase 2

Dyslipidemias | RNA therapy | Cardiovascular |Pfizer, Inc.|Trials Updated: Oct 4, 2022

Vupanorsen development status

Highest phase Phase 2
Registered trials 3 across 1 sponsor since Jul 2020

Vupanorsen target and mechanism

Molecular targetASGR1, ANGPTL3
Target classBinding Agent
ModalityRNA therapy

Also known as PF-07285557

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment286

FDA Designations

No designations recorded

Vupanorsen clinical trials

Vupanorsen · 1 trial · 3 indications

Phase 2 1
NCT04516291A Dose-Ranging Study With Vupanorsen (TRANSLATE-TIMI 70)Dyslipidemias
COMPLETED286 Analytics
PHASE2COMPLETED
A Dose-Ranging Study With Vupanorsen (TRANSLATE-TIMI 70)
DyslipidemiasUnlock trial analytics

Study Endpoints

Primary Endpoints

Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 24
Baseline, Week 24

Fasting was required at least 10 hours before blood sample collection. Baseline was calculated using the average of all values obtained at Screening and on Day 1 prior to dosing.

Secondary Endpoints

Percent Change From Baseline in Triglyceride (TG), Apolipoprotein B (ApoB), Low-Density Lipoprotein-Cholesterol (LDL-C), and Non-HDL-C at Week 16
Baseline, Week 16
Percent Change From Baseline in TG, ApoB, and LDL-C at Week 24
Baseline, Week 24
Percent Change From Baseline in Angiopoietin-like Protein 3 (ANGPTL3) at Week 16
Baseline, Week 16
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORNo drug
Vupanorsen 80 mg every 4 weeksEXPERIMENTAL80 milligrams (mg) given subcutaneously every 4 weeks.
Vupanorsen 60 mg every 2 weeksEXPERIMENTAL60 mg given subcutaneously every 2 weeks.
Vupanorsen 120 mg every 4 weeksEXPERIMENTAL120 mg given subcutaneously every 4 weeks.
Vupanorsen 80 mg every 2 weeksEXPERIMENTAL80 mg given subcutaneously every 2 weeks.
Vupanorsen 160 mg every 4 weeksEXPERIMENTAL160 mg given subcutaneously every 4 weeks.
Vupanorsen 120 mg every 2 weeksEXPERIMENTAL120 mg given subcutaneously every 2 weeks.
Vupanorsen 160 mg every 2 weeksEXPERIMENTAL160 mg given subcutaneously every 2 weeks.

Interventions

NameTypeDescription
VupanorsenDRUGVupanorsen and placebo will be provided as prefilled syringes packaged and dispensed in cartons with tamper-evident seals. Only single-use syringes will be used.
PlaceboDRUGVupanorsen and placebo will be provided as prefilled syringes packaged and dispensed in cartons with tamper-evident seals. Only single-use syringes will be used.
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites114

Inclusion Criteria: 1. Male or female participants aged ≥40 years at Screening. 2. Fasting non-HDL-C at Screening ≥100 mg/dL. 3. Fasting TG at Screening of 150 to 500 mg/dL, inclusive, which may be repeated once if deemed necessary. 4. Participants must be on a stable dose of a statin for at least ...

Countries:United StatesCanadaPoland
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Frequently asked questions about Vupanorsen

What is Vupanorsen used for?

Vupanorsen is an investigational RNA therapy being studied for dyslipidemias, a group of conditions involving abnormal levels of lipids such as cholesterol and triglycerides in the blood. It is being developed by Pfizer and has been evaluated in a Phase 2 clinical trial in adults with dyslipidemias, hyperlipidemias, and hyperlipoproteinemias.

What does Vupanorsen target?

Vupanorsen targets ASGR1 and ANGPTL3. It is an RNA therapy designed as a binding agent directed at these molecular targets. ANGPTL3 is involved in regulating lipid metabolism, and ASGR1 is a receptor expressed on liver cells. By targeting these proteins, Vupanorsen aims to affect lipid levels in the blood.

Who is developing Vupanorsen?

Vupanorsen is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker symbol PFE. Pfizer is the company responsible for the clinical development of this RNA therapy for dyslipidemias.

What phase is Vupanorsen in?

Vupanorsen is in Phase 2 clinical development. It has completed one Phase 2 trial, and there are currently no active trials listed. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is Vupanorsen in?

Vupanorsen has been studied in one completed Phase 2 clinical trial, NCT04516291, titled A Dose-Ranging Study With Vupanorsen (TRANSLATE-TIMI 70). This randomized, double-blind, placebo-controlled trial enrolled 286 participants with dyslipidemias, hyperlipidemias, and hyperlipoproteinemias across the United States, Canada, and Poland.