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COMPLETED Phase 1

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

NCT04973657 · View on ClinicalTrials.gov ↗

Study Summary

Subjects will be administered multiple doses of VK0214 in a cohort dose escalation process. A total of up to 36 subjects will be enrolled in the study, into one of three dose cohorts. For each cohort, up to 12 subjects will be randomized to receive VK0214 or placebo in a 3:1 ratio so that there will be a total of up to 9 subjects for each of the active doses and up to 3 subjects dosed with placebo in each cohort.

Interventions

  • OTHER Placebo
  • DRUG VK0214

Study Locations (9)

Other

  • Viking Clinical Site 214 — Bordeaux
  • Viking Clinical Site 215 — Montpellier
  • Viking Clinical Site 209 — Leipzig
  • Viking Clinical Site 210 — Milan
  • Viking Clinical Site 212 — London

California

  • Viking Clinical Site 203 — Palo Alto

Florida

  • Viking Clinical Site 207 — Gainesville

Maryland

  • Viking Clinical Site 201 — Baltimore

Washington

  • Viking Clinical Site 205 — Seattle

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2021-06-22
Est. Completion 2024-11-08
Phase Phase 1

Sponsor

Viking Therapeutics

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04973657

The ClinicalTrials.gov registry entry for NCT04973657 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Viking Therapeutics, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Adrenomyeloneuropathy Form (AMN) of X-linked Adrenoleukodystrophy (X-ALD) appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04973657 reports 9 study locations spanning 5 distinct geographic areas — top geographies include Other, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04973657 about?

NCT04973657 is a clinical study titled "A Study to Assess the Pharmacodynamics of VK0214 in Male Subjects With AMN". Subjects will be administered multiple doses of VK0214 in a cohort dose escalation process. A total of up to 36 subjects will be enrolled in the study, into one of three dose cohorts. For each cohort, up to 12 subjects will be randomized to receive VK0214 or placebo in a 3:1 ratio so that there will...

What is the current status of trial NCT04973657?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2021-06-22. Estimated completion is 2024-11-08.

What conditions does trial NCT04973657 study?

This clinical trial studies the following conditions: Adrenomyeloneuropathy Form (AMN) of X-linked Adrenoleukodystrophy (X-ALD). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04973657?

The interventions under investigation include: Placebo (OTHER), VK0214 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04973657?

This trial is sponsored by Viking Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04973657 being conducted?

This trial has 9 study locations across California, Florida, Maryland, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial