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VK2809

Phase 2

Hyperlipidemia | Small molecule | Cardiovascular |Viking Therapeutics, Inc.|Last Updated: Jun 14, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment59

FDA Designations

No designations recorded

Clinical trial landscape

VK2809 · 2 trials · 3 indications

Phase 2 2
NCT04173065A Study to Assess the Efficacy and Safety of VK2809 for 52 Weeks in Subjects With Biopsy Proven NASHNASH - Nonalcoholic Steatohepatitis
COMPLETED248 Analytics
NCT02927184Safety and Tolerability of VK2809 in Patients With Primary Hypercholesterolemia and Non-Alcoholic Fatty Liver DiseaseHyperlipidemia
COMPLETED59 Analytics
PHASE2COMPLETED
A Study to Assess the Efficacy and Safety of VK2809 for 52 Weeks in Subjects With Biopsy Proven NASH
NASH - Nonalcoholic SteatohepatitisUnlock trial analytics
PHASE2COMPLETED
Safety and Tolerability of VK2809 in Patients With Primary Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease
HyperlipidemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Liver Fat
12 weeks

Relative change in liver fat content (assessed by MRI-PDFF) from baseline to Week 12 in subjects treated with VK2809 compared to the change in subjects treated with placebo.

Change in LDL-C in patients receiving VK2809 compared to placebo
12 weeks

Secondary Endpoints

NASH CRN fibrosis score
52 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
1.0 mgEXPERIMENTAL -
2.5mgEXPERIMENTAL -
5.0 mgEXPERIMENTAL -
10 mgEXPERIMENTAL -
VK2809 (5mg)EXPERIMENTAL5mg VK2809 capsule
VK2809 (10mg)EXPERIMENTAL10mg VK2809 capsule
VK2809 (10mg QOD)EXPERIMENTAL10mg VK2809 capsule

Interventions

NameTypeDescription
VK2809DRUGCapsule
PlacebosDRUGCapsule
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites79

Inclusion Criteria: 1. Provide a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study and is willing and able to participate; 2. Have a histologically-confirmed diagnosis of...

Countries:United StatesBelgiumFranceMexicoPuerto Rico
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Frequently asked questions about VK2809

What is VK2809 used for?

VK2809 is an investigational small molecule being developed for hyperlipidemia and nonalcoholic steatohepatitis (NASH). It has been studied in patients with primary hypercholesterolemia and non-alcoholic fatty liver disease, as well as in subjects with biopsy-proven NASH. The drug is currently in Phase 2 clinical development.

What does VK2809 target?

VK2809 is a thyroid hormone receptor beta agonist. It works by selectively activating the thyroid hormone receptor beta, which plays a role in lipid metabolism and liver function. This mechanism is being investigated for its potential effects on cholesterol levels and liver fat in conditions like hyperlipidemia and NASH.

Who makes VK2809?

VK2809 is being developed by Viking Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol VKTX. The company is conducting clinical trials to evaluate the safety and efficacy of VK2809 in patients with hyperlipidemia and nonalcoholic steatohepatitis.

What phase is VK2809 in?

VK2809 is in Phase 2 clinical development. It has completed two Phase 2 trials, including a study in patients with primary hypercholesterolemia and non-alcoholic fatty liver disease, and a larger study in subjects with biopsy-proven NASH. The drug is not yet approved and remains investigational.

What clinical trials is VK2809 in?

VK2809 has completed two Phase 2 clinical trials. The first, NCT02927184, evaluated safety and tolerability in 59 patients with primary hypercholesterolemia and non-alcoholic fatty liver disease in the United States. The second, NCT04173065, assessed efficacy and safety over 52 weeks in 248 subjects with biopsy-proven NASH across multiple countries.

Is VK2809 the same as any other drug?

VK2809 is the primary name used for this investigational compound in clinical trials and scientific literature. No alternative names have been reported for this drug in the available clinical trial information. It is a distinct small molecule being developed by Viking Therapeutics for metabolic and liver conditions.