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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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Evaluate the Pharmacokinetics of VK0214

Other outcome measures

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Viking Therapeutics, Inc.Lead Sponsor

5 Previous Clinical Trials

727 Total Patients Enrolled

Media Library

VK0214 (Steroid) Clinical Trial Eligibility Overview. Trial Name: NCT04973657 — Phase 1

Adrenoleukodystrophy Research Study Groups: VK0214 Active 40mg, Placebo, VK0214 Active 20mg

Adrenoleukodystrophy Clinical Trial 2023: VK0214 Highlights & Side Effects. Trial Name: NCT04973657 — Phase 1

VK0214 (Steroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04973657 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is the participant pool of this research project expanding?

"Correct. The clinicaltrials.gov website shows that this examination is presently recruiting individuals, with the first post being made June 22nd 2021 and most recent update on October 31st 2022. 36 participants are needed from 5 different locations for this study."

Answered by AI

Has the FDA given its seal of approval to VK0214?

"VK0214's safety has been evaluated as a score of 1, given that there is only preliminary clinical data available attesting to its efficacy and security."

Answered by AI

Could you provide an estimate of the number of medical facilities currently operating this experiment?

"Patients are able to take part in this trial through Viking Clinical Site 201 in Baltimore, Maryland, Viking Clinical Site 207 located in Gainesville, Florida and the one based out of New york City. There are also 5 other sites that offer participation."

Answered by AI

Is there an ongoing recruitment for this research endeavor?

"Affirmative. As per the clinicaltrials.gov entry, this study is actively seeking participants since its initial posting on June 22nd 2021 and as of October 31st 2022 it needs 36 individuals to be recruited from 5 facilities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess the Pharmacodynamics of VK0214 in Male Subjects With AMN

2021. "A Study to Assess the Pharmacodynamics of VK0214 in Male Subjects With AMN". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04973657.