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
2 other identifiers
interventional
286
3 countries
114
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2020
Shorter than P25 for phase_2
114 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2020
CompletedFirst Posted
Study publicly available on registry
August 18, 2020
CompletedStudy Start
First participant enrolled
September 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 29, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 6, 2021
CompletedResults Posted
Study results publicly available
October 4, 2022
CompletedOctober 4, 2022
September 1, 2022
1 year
August 13, 2020
September 6, 2022
September 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at 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.
Baseline, Week 24
Secondary Outcomes (4)
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
Percent Change From Baseline in ANGPTL3 at Week 24
Baseline, Week 24
Study Arms (8)
Placebo
PLACEBO COMPARATORNo drug
Vupanorsen 80 mg every 4 weeks
EXPERIMENTAL80 milligrams (mg) given subcutaneously every 4 weeks.
Vupanorsen 60 mg every 2 weeks
EXPERIMENTAL60 mg given subcutaneously every 2 weeks.
Vupanorsen 120 mg every 4 weeks
EXPERIMENTAL120 mg given subcutaneously every 4 weeks.
Vupanorsen 80 mg every 2 weeks
EXPERIMENTAL80 mg given subcutaneously every 2 weeks.
Vupanorsen 160 mg every 4 weeks
EXPERIMENTAL160 mg given subcutaneously every 4 weeks.
Vupanorsen 120 mg every 2 weeks
EXPERIMENTAL120 mg given subcutaneously every 2 weeks.
Vupanorsen 160 mg every 2 weeks
EXPERIMENTAL160 mg given subcutaneously every 2 weeks.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Male or female participants aged ≥40 years at Screening.
- Fasting non-HDL-C at Screening ≥100 mg/dL.
- Fasting TG at Screening of 150 to 500 mg/dL, inclusive, which may be repeated once if deemed necessary.
- Participants must be on a stable dose of a statin for at least 1 month before Screening and plan to remain on the same medication and dose for the duration of the study.
- Body weight ≥50 kg and ≤136 kg at Screening.
- Capable of giving signed informed consent.
You may not qualify if:
- Participant has active liver disease (other than NAFLD or NASH, which are permitted), including chronic active hepatitis B or C or primary biliary cirrhosis.
- Uncontrolled hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>100 mmHg). Note: participants who are on an anti-hypertensive medication to treat hypertension should be on a stable dose at least 1 month prior to Screening. The investigator should ensure participant took anti-hypertensive medication as prescribed prior to evaluation of blood pressure.
- Participant with a known bleeding diathesis or coagulation disorder.
- Participants with ANY of the following abnormalities in clinical laboratory tests at Screening, as assessed by the central laboratory and confirmed by a single repeat test, if deemed necessary: HbA1c ≥9.5% eGFR \<30 mL/min/1.73 m2 (as determined by the CKD-Epi equation) ALT or AST \>2 × ULN Total bilirubin ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have a direct bilirubin measured and would be eligible for this study provided the direct bilirubin is ≤ULN Platelet count \<LLN
- History of clinically significant acute cardiac event within 3 months before Screening (includes ischemic stroke, transient ischemic attack, myocardial infarction, revascularization procedures, hospitalization for heart failure).
- Presence of New York Heart Association Functional Classification IV heart failure symptoms at Screening.
- Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated.
- Current history of alcoholism or drug addiction according to Diagnostic and Statistical Manual of Mental Disorders IV criteria within 12 months prior to Screening. Use of any recreational drugs within 12 months prior to Screening.
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Prior/Concomitant Therapy:
- Prior treatment at any time with vupanorsen.
- Prior treatment with any oligonucleotide (including small interfering ribonucleic acid) within 6 months of Screening or prior treatment with inclisiran within 12 months of Screening.
- Use of TG lowering medication (eg, Vascepa \[icosapent ethyl\]), non-prescription dietary supplements (eg, fish oil) or other cholesterol lowering medication (eg, fibric acid derivatives, niacin, PCSK9 inhibitors, bile acid sequestrants, bempedoic acid) 30 days prior to Screening, other than statins and ezetimibe.
- Use of warfarin or other coumarins, direct thrombin inhibitors, Factor Xa inhibitors, heparins or heparinoids 30 days prior to Screening.
- Prior/Concurrent Clinical Study Experience:
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- The TIMI Study Groupcollaborator
Study Sites (114)
Horizon Clinical Research Associates, PLLC
Gilbert, Arizona, 85295, United States
Scottsdale Medical Imaging Research, LLC
Gilbert, Arizona, 85297, United States
CARTI
Little Rock, Arkansas, 72205, United States
Atria Clinical Research
Little Rock, Arkansas, 72209, United States
Clinical Trials Research
Lincoln, California, 95648, United States
Diagnostic Radiological Imaging
Sacramento, California, 95825, United States
West Coast Radiology
Santa Ana, California, 92705, United States
University Clinical Investigators, Inc.
Tustin, California, 92780, United States
Tower Radiology Parsons
Brandon, Florida, 33511, United States
Tower Radiology
Brandon, Florida, 33511, United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756, United States
Westside Center for Clinical Research
Jacksonville, Florida, 32205, United States
Borland-Groover Clinic
Jacksonville, Florida, 32256, United States
Precision Imaging Centers
Jacksonville, Florida, 32256, United States
Care Partners Clinical Research, LLC
Jacksonville, Florida, 32277, United States
Advanced Research Institute, Inc.
New Port Richey, Florida, 34653, United States
Sand Lakes Imaging
Orlando, Florida, 32819, United States
St Johns Center for Clinical Research
Saint Augustine, Florida, 32086, United States
Clinical Research of Central Florida
Winter Haven, Florida, 33880, United States
Alliance for Multispecialty Research, LLC
El Dorado, Kansas, 67042, United States
Susan B. Allen Memorial Hospital
El Dorado, Kansas, 67042, United States
L-MARC Research Center
Louisville, Kentucky, 40213, United States
Heartland Imaging
Louisville, Kentucky, 40222, United States
Maryland Cardiovascular Specialists
Baltimore, Maryland, 21229, United States
Seton Imaging Center
Baltimore, Maryland, 21229, United States
Lahey Clinic Hospital and Medical Center
Burlington, Massachusetts, 01805, United States
Pentucket Medical Associates
Haverhill, Massachusetts, 01830, United States
Regions Hospital - HealthPartners
Saint Paul, Minnesota, 55101, United States
Viable Research Management LLC
Henderson, Nevada, 89014, United States
Pueblo Medical Imaging
Henderson, Nevada, 89074, United States
Capital Cardiology Associates
Albany, New York, 12211, United States
ImageCare Latham
Latham, New York, 12110, United States
Randolph Health Internal Medicine
Asheboro, North Carolina, 27203, United States
Randolph Health MRI Center
Asheboro, North Carolina, 27205, United States
PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
Cary, North Carolina, 27518, United States
Wake Radiology
Cary, North Carolina, 27518, United States
Accellacare - Raleigh
Raleigh, North Carolina, 27609, United States
PMG Research of Raleigh, LLC
Raleigh, North Carolina, 27609, United States
Wake Radiology Diagnostic Imaging Inc
Raleigh, North Carolina, 27609, United States
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, 27103, United States
Hightop Medical Research Center
Cincinnati, Ohio, 45224, United States
Imaging Research Center-Cincinnati Children's
Cincinnati, Ohio, 45229, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Perelman Center for Advanced Medicine, Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Clermont Radiology Orangeburg
Orangeburg, South Carolina, 29118, United States
South Carolina Clinical Research LLC
Orangeburg, South Carolina, 29118, United States
Tennessee Center for Clinical Trials
Tullahoma, Tennessee, 37388, United States
Tullahoma HMA, LLC d\b\a Tennova HealthCare Harton
Tullahoma, Tennessee, 37388, United States
Dallas Diabetes Research Center
Dallas, Texas, 75230, United States
Southwest Diagnostic Imaging Center
Dallas, Texas, 75231, United States
SimonMed Houston
Houston, Texas, 77030, United States
Southwest Clinical Trials
Houston, Texas, 77074, United States
Medical Center Hospital
Odessa, Texas, 79761, United States
Permian Research Foundation
Odessa, Texas, 79761, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, 84121, United States
National Clinical Research, Inc.
Richmond, Virginia, 23294, United States
Rainier Clinical Research Center
Renton, Washington, 98057, United States
Bellevue Medical Imaging
Seattle, Washington, 98166, United States
Universal Research Group, LLC
Tacoma, Washington, 98405, United States
C-endo
Edmonton, Alberta, T6H 2L4, Canada
MIC Medical Imaging
Edmonton, Alberta, T6J 5E5, Canada
Synergy Medical Clinic
Sherwood Park, Alberta, T8H 0N2, Canada
Access MRI
Surrey, British Columbia, V3S 9A5, Canada
SMH Cardiology Clinical Trials Inc.
Surrey, British Columbia, V3V 0C6, Canada
Nova Scotia Health Authority QE II Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7, Canada
Nova Scotia Health Authority QE II Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9, Canada
LMC Clinical Research Inc. (Barrie)
Barrie, Ontario, L4N 7L3, Canada
Aggarwal and Associates Limited
Brampton, Ontario, L6T 0G1, Canada
LMC Clinical Research Inc. (Thornhill)
Concord, Ontario, L4K 4M2, Canada
LMC Clinical Research Inc. (Etobicoke)
Etobicoke, Ontario, M9R 4E1, Canada
Dawson Clinical Research
Guelph, Ontario, N1H 1B1, Canada
KMH Cardiology Centres Inc.
Kitchener, Ontario, N2M 5N4, Canada
Milestone Research Inc.
London, Ontario, N5W 6A2, Canada
Robarts Research Institute, Western University
London, Ontario, N6A 5B7, Canada
GNMI Medical Imaging
Mississauga, Ontario, L5R 3K6, Canada
GNMI Medical Imaging
Mississauga, Ontario, L5R 3K7, Canada
GNMI MRI and CT Medical Imaging
Mississauga, Ontario, L6R 3K7, Canada
North York Diagnostic and Cardiac Centre
North York, Ontario, M6B 3H7, Canada
Bluewater Clinical Research Group Inc.
Sarnia, Ontario, N7T 4X3, Canada
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, M4G 1R8, Canada
Dr. Anil K. Gupta Medicine Professional Corporation
Toronto, Ontario, M9V 4B4, Canada
Devonshire Clinical Research Inc.
Woodstock, Ontario, N4S 5P5, Canada
Resonance Magnetique du Saguenay-Lac-Saint-Jean
Chicoutimi, Quebec, G7H 4J1, Canada
Ecogene-21
Chicoutimi, Quebec, G7H 7K9, Canada
Manna Research (Mirabel)
Mirabel, Quebec, J7J 2K8, Canada
Recherche GCP Research
Montreal, Quebec, H1M 1B1, Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
Research Institute of the McGill University Health Center
Montreal, Quebec, H4A 3J1, Canada
Research Institute of the McGill University Health Centre
Montreal, Quebec, H4A 3J1, Canada
Radimed West Island
Pointe-Claire, Quebec, H9R 4R9, Canada
Diex Recherche Joliette
Saint-Charles-Borromée, Quebec, J6E 2B4, Canada
IRM Quebec - Complexe Synase
Québec, G1J 0H4, Canada
IRM Quebec Synase
Québec, G1J 0H4, Canada
Diex Recherche Quebec Inc.
Québec, G1N 4V3, Canada
Centre de Recherche Saint-Louis
Québec, G1W4R4, Canada
Alpha Recherche Clinique
Québec, G2J 0C4, Canada
NZOZ Kendron
Bialystok, 15-402, Poland
ClinicMed Daniluk, Nowak Spolka Jawna
Bialystok, 15-879, Poland
Malopolskie Centrum Sercowo-Naczyniowe PAKS - Chrzanow
Chrzanów, 32-500, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, 80-546, Poland
Centrum Medyczne Enel-Med., Oddzial Alfa Plaza - Gdynia
Gdynia, 81-366, Poland
Kardio Brynow
Katowice, 40-555, Poland
Niepubliczny Zaklad Opieki Zdrowotnej "TERAPIA OPTIMA"
Katowice, 40-752, Poland
HELIMED Katowice - Rezonans Magnetyczny, Tomografia Komputerowa (MRI)
Katowice, 40-760, Poland
HELIMED Katowice - Rezonans Magnetyczny, Tomografia Komputerowa
Katowice, 40-760, Poland
"TWOJA PRZYCHODNIA" Sp. z o.o.
Lublin, 20-857, Poland
Top Medical Lublin
Lublin, 20-883, Poland
Centrum Zdrowia Metabolicznego Pawel Bogdanski
Poznan, 60-589, Poland
Arterieart Sp. z o.o.
Puszczykowo, 62-041, Poland
SZPITAL SW. ELZBIETY W KATOWICACH Polsko-Amerykanskie Kliniki Serca
Tychy, 43-100, Poland
Futuremeds
Wroclaw, 50-088, Poland
Skanmex (MRI)
Wroclaw, 50-450, Poland
Wro Medica
Wroclaw, 51-685, Poland
TOMMA Pracownia rezonansu magnetycznego we Wroclawiu
Wroclaw, 53-234, Poland
Related Publications (1)
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.
PMID: 35369705DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2020
First Posted
August 18, 2020
Study Start
September 28, 2020
Primary Completion
September 29, 2021
Study Completion
December 6, 2021
Last Updated
October 4, 2022
Results First Posted
October 4, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.