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Steroid
VK0214 for Adrenoleukodystrophy
Phase 1
Recruiting
Research Sponsored by Viking Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Summary
This trial is testing a new drug, VK0214, given in multiple doses to see what the safest dose is. Up to 36 people will be enrolled, with some given the drug and some given a placebo.
Who is the study for?
This trial is for adult males with X-linked adrenoleukodystrophy (X-ALD) who show symptoms of adrenomyeloneuropathy (AMN) or adrenal insufficiency, confirmed by genetic testing and elevated VLCFAs. Participants must be informed about the study and willing to join. Those using certain lipid-lowering agents, with untreated primary adrenal insufficiency, cerebral X-ALD, or significant acute health issues are excluded.
What is being tested?
The study tests VK0214's effects on AMN in a dose escalation format across three groups. Each group has up to 12 men taking either VK0214 or placebo at a 3:1 ratio. The goal is to find out how different doses of VK0214 affect the body compared to a placebo.
What are the potential side effects?
While specific side effects for VK0214 aren't listed here, common ones may include reactions at the administration site, gastrointestinal discomforts like nausea or diarrhea, fatigue, potential liver enzyme changes and possibly hormonal imbalances.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of treatment-emergent adverse events (TEAEs) and treatment-emergent serious AEs (TESAEs)
Secondary study objectives
Evaluate the Pharmacokinetics of VK0214
Other study objectives
Evaluate plasma VLCFAs changes
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: VK0214 Active 40mgExperimental Treatment1 Intervention
40mg QD
Group II: VK0214 Active 20mgExperimental Treatment1 Intervention
20mg QD
Group III: PlaceboPlacebo Group1 Intervention
Placebo QD
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Who is running the clinical trial?
Viking Therapeutics, Inc.Lead Sponsor
5 Previous Clinical Trials
727 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently taking Lorenzo's Oil, erucic acid-containing products, or any other medication that can affect certain lipid levels.You have a specific condition called primary adrenal insufficiency that has not been treated yet.You have a serious ongoing health condition that could put you at risk during the study, like liver, kidney, digestive, lung, immune, hormone, blood, or cancer problems.You have taken a drug that targets TRβ or is being tested for X-ALD AMN within the last 30 days before screening.You have been diagnosed with X-linked adrenoleukodystrophy (X-ALD) through genetic testing and have high levels of VLCFAs.You currently have symptoms of adrenomyeloneuropathy (AMN) or adrenal insufficiency.You have the type of X-ALD that affects the brain, as shown by medical records or MRI scans.
Research Study Groups:
This trial has the following groups:- Group 1: VK0214 Active 40mg
- Group 2: Placebo
- Group 3: VK0214 Active 20mg
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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