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VK0214

Phase 1

Adrenomyeloneuropathy Form (AMN) of X-linked Adrenoleukodystrophy (X-ALD) | Small molecule | Rare Disease |Viking Therapeutics, Inc.|Last Updated: Feb 17, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

VK0214 · 1 trial · 1 indication

Phase 1 1
NCT04973657A Study to Assess the Pharmacodynamics of VK0214 in Male Subjects With AMNAdrenomyeloneuropathy Form (AMN) of X-linked Adrenoleukodystrophy (X-ALD)
COMPLETED24 Analytics
PHASE1COMPLETED
A Study to Assess the Pharmacodynamics of VK0214 in Male Subjects With AMN
Adrenomyeloneuropathy Form (AMN) of X-linked Adrenoleukodystrophy (X-ALD)Unlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of treatment-emergent adverse events (TEAEs) and treatment-emergent serious AEs (TESAEs)
28 days

Evaluate the safety and tolerability of multiple oral doses of VK0214 in subjects with AMN

Secondary Endpoints

Evaluate the Pharmacokinetics of VK0214
28 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeOTHER

Treatment Arms

ArmTypeDescription
VK0214 Active 20mgEXPERIMENTAL20mg QD
VK0214 Active 40mgEXPERIMENTAL40mg QD
PlaceboPLACEBO_COMPARATORPlacebo QD

Interventions

NameTypeDescription
VK0214DRUGAPI in capsule
PlaceboOTHERAPI in capsule
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Provide a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study and is willing and able to participate. * Have diagnosis of X-linked adrenoleukodystrophy (X-ALD) by genetic testing and elevated...

Countries:United StatesFranceGermanyItalyUnited Kingdom
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Frequently asked questions about VK0214

What is VK0214 used for?

VK0214 is an investigational small molecule being developed for the adrenomyeloneuropathy form (AMN) of X-linked adrenoleukodystrophy (X-ALD), a rare inherited disease. It is designed to address this condition, though it is still in clinical development and not yet approved.

Who makes VK0214?

VK0214 is being developed by Viking Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker VKTX. The company is conducting clinical research on this investigational drug for the AMN form of X-linked adrenoleukodystrophy.

What phase is VK0214 in?

VK0214 is in Phase 1 clinical development. It has completed a Phase 1 trial, and it remains an investigational drug, meaning it has not been approved by regulatory authorities. Further studies would be needed to establish its safety and efficacy.

What clinical trials is VK0214 in?

VK0214 has one completed Phase 1 clinical trial, identified as NCT04973657, titled "A Study to Assess the Pharmacodynamics of VK0214 in Male Subjects With AMN." This randomized, double-blind, placebo-controlled study enrolled 24 participants across the United States, France, Germany, Italy, and the United Kingdom.

Is VK0214 the same as any other drug?

VK0214 is the primary name for this investigational drug; no alternative names have been reported. It is a distinct small molecule being studied by Viking Therapeutics for the AMN form of X-linked adrenoleukodystrophy.