Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04973657 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Pharmacodynamics of VK0214 in Male Subjects With AMN
A Phase 1 study of Adrenomyeloneuropathy Form (AMN) of X-linked Adrenoleukodystrophy (X-ALD), sponsored by Viking Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 9
- Study locations
NCT04973657: Completed Phase 1 study of Adrenomyeloneuropathy Form (AMN) of X-linked Adrenoleukodystrophy (X-ALD), sponsored by Viking Therapeutics.
NCT04973657 is a Phase 1 study of Adrenomyeloneuropathy Form (AMN) of X-linked Adrenoleukodystrophy (X-ALD) that has completed, run by Viking Therapeutics. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). The trial reports 9 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04973657, a Phase 1 study of Adrenomyeloneuropathy Form (AMN) of X-linked Adrenoleukodystrophy (X-ALD), has completed, sponsored by Viking Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 9
- Study locations
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.
Primary Outcome
Evaluate the safety and tolerability of multiple oral doses of VK0214 in subjects with AMN
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2021-06-22 |
| Est. Completion | 2024-11-08 |
| Phase | Phase 1 |
What the finished NCT04973657 record still lists
NCT04973657 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
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.
NCT04973657 lists 9 locations in 5 states (Other, California, Florida).
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).
What interventions are being tested in trial NCT04973657?
The interventions under investigation include: Placebo (OTHER), VK0214 (DRUG).
Who is sponsoring clinical trial NCT04973657?
This trial is sponsored by Viking Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04973657's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02331979 · 24 participants · NA
Improving Bladder Function in SCI by Neuromodulation
- NCT03096197 · 24 participants · NA
Exoskeleton and Spinal Cord Stimulation for SCI
- NCT03223922 · 24 participants · NA
Neurocognitive Functioning With Genu-Sparing Whole Brain Radiation Therapy for Brain Metastases
- NCT03326921 · 24 participants · Phase 1
HA-1 T TCR T Cell Immunotherapy for the Treatment of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell Transplant
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI