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NCT05001945 · ClinicalTrials.gov registry record · Phase 2
Trial on the Safety and Efficacy of MLS-101 in Patients With Uncontrolled Hypertension
A Phase 2 study, sponsored by Mineralys Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
NCT05001945: Completed Phase 2 study, sponsored by Mineralys Therapeutics.
NCT05001945 is a Phase 2 study that has completed, run by Mineralys Therapeutics. The registered enrollment target is 200 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05001945, a Phase 2 study, has completed, sponsored by Mineralys Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
Study Summary
A randomized, double-blind, placebo-controlled, dose-ranging, Phase II study to evaluate the safety, efficacy, and tolerability of MLS-101 in Subjects With Uncontrolled Hypertension
Primary Outcome
The primary outcome was defined as the change in office-measured (mean of last 2 of 5 unattended measurements using an automated oscillometric sphygmomanometer device after approximately 5 minutes of rest in the seated position) SBP from baseline to the end of Study Week 8. The primary efficacy analysis was performed using a mixed model repeated measures (MMRM) approach with defined fixed effects per the statistical analysis plan. A least-square estimate of the mean difference between each dose
Interventions
- DRUG MLS-101 (Part I)
- OTHER Placebo (Part I)
- OTHER Placebo (Part II)
- DRUG MLS-101 (Part II)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2021-07-01 |
| Est. Completion | 2022-10-07 |
| Phase | Phase 2 |
What the finished NCT05001945 record still lists
NCT05001945 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher).
The record links to 0 conditions, and to 4 interventions - of which MLS-101 (Part I) is the first listed.
NCT05001945 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05001945 about?
NCT05001945 is a clinical study titled "Trial on the Safety and Efficacy of MLS-101 in Patients With Uncontrolled Hypertension". A randomized, double-blind, placebo-controlled, dose-ranging, Phase II study to evaluate the safety, efficacy, and tolerability of MLS-101 in Subjects With Uncontrolled Hypertension
What is the current status of trial NCT05001945?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2021-07-01. Estimated completion is 2022-10-07.
What interventions are being tested in trial NCT05001945?
The interventions under investigation include: MLS-101 (Part I) (DRUG), Placebo (Part I) (OTHER), Placebo (Part II) (OTHER), MLS-101 (Part II) (DRUG).
Who is sponsoring clinical trial NCT05001945?
This trial is sponsored by Mineralys Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05001945's enrollment target sits among peer trials
200 304th of 2000 higher than 1,652 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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