A Dose-Ranging Study With Vupanorsen (TRANSLATE-TIMI 70)
Recruiting in Palo Alto (17 mi)
+112 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Pfizer
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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).
Research Team
PC
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Eligibility Criteria
Inclusion Criteria
Fasting TG at Screening of 150 to 500 mg/dL, inclusive, which may be repeated once if deemed necessary.
Male or female participants aged ≥40 years at Screening.
Fasting non-HDL-C at Screening ≥100 mg/dL.
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Treatment Details
Interventions
- Vupanorsen (Antisense Oligonucleotide)
Participant Groups
8Treatment groups
Experimental Treatment
Placebo Group
Group I: Vupanorsen 80 mg every 4 weeksExperimental Treatment1 Intervention
80 milligrams (mg) given subcutaneously every 4 weeks.
Group II: Vupanorsen 80 mg every 2 weeksExperimental Treatment1 Intervention
80 mg given subcutaneously every 2 weeks.
Group III: Vupanorsen 60 mg every 2 weeksExperimental Treatment1 Intervention
60 mg given subcutaneously every 2 weeks.
Group IV: Vupanorsen 160 mg every 4 weeksExperimental Treatment1 Intervention
160 mg given subcutaneously every 4 weeks.
Group V: Vupanorsen 160 mg every 2 weeksExperimental Treatment1 Intervention
160 mg given subcutaneously every 2 weeks.
Group VI: Vupanorsen 120 mg every 4 weeksExperimental Treatment1 Intervention
120 mg given subcutaneously every 4 weeks.
Group VII: Vupanorsen 120 mg every 2 weeksExperimental Treatment1 Intervention
120 mg given subcutaneously every 2 weeks.
Group VIII: PlaceboPlacebo Group1 Intervention
No drug
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Viable Research Management LLCHenderson, NV
Rainier Clinical Research CenterRenton, WA
Universal Research Group, LLCTacoma, WA
Research Institute of the McGill University Health CentreMontreal, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Trials
4712
Patients Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13
The TIMI Study Group
Collaborator
Trials
22
Patients Recruited
129,000+
TIMI Study Group
Collaborator
Trials
2
Patients Recruited
920+