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Trial on the Safety and Efficacy of MLS-101 in Patients With Uncontrolled Hypertension (Target-HTN Trial)

Phase 2
Waitlist Available
Research Sponsored by Mineralys 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 8 weeks

Summary

This trial is testing a new medication called MLS-101 to see if it can help people with high blood pressure that isn't controlled by other treatments. The study will check if MLS-101 is safe and effective at lowering blood pressure. Researchers hope it works by relaxing blood vessels or reducing fluid in the body.

Eligible Conditions
  • Renal Hypertension

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in Office-measured Systolic Blood Pressure (SBP) at Study Week 8 Compared to Placebo
Secondary study objectives
Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean Systolic Blood Pressure (SBP) and Mean Diastolic Blood Pressure (DBP) From Baseline to End of Treatment (EoT)
Number of Participants With Blood Pressure ≤ 130/80 mmHg at Week 8
Week 8 Change From Baseline in Office-measured Diastolic Blood Pressure (DBP)

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Dose 3 (Part I)Experimental Treatment1 Intervention
MLS-101 tablet(s) by mouth once or twice daily.
Group II: Dose 2 (Part I)Experimental Treatment1 Intervention
MLS-101 tablet(s) by mouth once or twice daily.
Group III: Dose 1 (Part I)Experimental Treatment1 Intervention
MLS-101 tablet(s) by mouth once or twice daily.
Group IV: Dose (Part II)Experimental Treatment1 Intervention
MLS-101 tablet(s) by mouth once daily.
Group V: Placebo (Part I)Placebo Group1 Intervention
Placebo tablet(s) by mouth once or twice daily.
Group VI: Placebo (Part II)Placebo Group1 Intervention
Placebo tablet(s) by mouth once daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MLS-101 (Part I)
2021
Completed Phase 2
~200
MLS-101 (Part II)
2021
Completed Phase 2
~200

Find a Location

Who is running the clinical trial?

Mineralys Therapeutics Inc.Lead Sponsor
4 Previous Clinical Trials
2,828 Total Patients Enrolled
~45 spots leftby Dec 2025
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