Hypertension, RenalPhase 2Target-HTNNCT05001945

Trial on the Safety and Efficacy of MLS-101 in Patients With Uncontrolled Hypertension

A Phase 2 study testing MLS-101 (Part I) and MLS-101 (Part II) in people with Hypertension, Renal, run by Mineralys Therapeutics Inc. at 44 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension, Renal
What is being tested?: MLS-101 (Part I) and MLS-101 (Part II)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 200 participants
Where: 44 sitesUnited States
Study dates: 1 Jul 2021to 7 Oct 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and nonpregnant, nonlactating female subjects ≥ 18 years of age.
Written informed consent Health Insurance Portability and Accountability Act authorization, and local patient privacy required documentation for this study have been obtained
Automated office blood pressure (AOBP) with SBP ≥ 130 mm Hg
Background antihypertensive treatment of ≥ 2 drugs
Serum cortisol ≥ 18 mcg/dL

Who cannot join

1. Concomitant use of epithelial sodium channel inhibitors or mineralocorticoid receptor antagonists
3. Subjects with hypokalemia
4. Subjects with hyperkalemia
5. Subjects with serum cortisol < 3 mcg/dL
6. Subjects with serum sodium < 135 mEq/L
7. Subjects with estimated glomerular filtration rate < 60 mL/min/1.73m2

Show all 26Show fewer

8. Subjects with type 1 or uncontrolled (hemoglobin A1c ≥ 9%) type 2 diabetes mellitus
9. Subjects with body mass index > 40 kg/m2
10. Subjects with unstable angina
11. Subjects with SBP ≥ 175 mm Hg or DBP ≥ 100 mm Hg for Part 1 and SBP ≥ 160 mm Hg or DBP ≥ 100 mm Hg for Part 2 at Pre-Screening, Screening/Start of Placebo Run-in, or Randomization
12. Subjects with a decrease in SBP ≥ 20 mm Hg or DBP ≥ 10 mm Hg from sitting to standing position at screening
13. Subjects who, in the opinion of the investigator, have suspected nonadherence to antihypertensive treatment
14. Subjects who, in the opinion of the investigator, have any major medical illness or symptoms
15. Subjects who, in the opinion of the investigator, have any acute or chronic medical or psychiatric condition
16. Subjects undergoing treatment with any of the following medications:
Topical corticoids
Sympathomimetic decongestants
Theophylline
Phosphodiesterase type 5 inhibitors
NSAIDs
Intramuscular steroids
Estrogen
Cytochromes
Strong CYP3A and CYP3A4 inducers
17. Subjects with known hypersensitivity to MLS-101 or any of the excipients
18. Subjects who are night-shift workers

Trial locations and contacts

44 sites in 1 country.

City, postcode or hospital

44 sites in 1 country

United States44 sites

Site 118
Albany, Georgia, 31707
Site 151
Arlington, Texas, 76012
Site 136
Arlington Heights, Illinois, 60005
Site 133
Asheboro, North Carolina, 27203
Site 138
Bossier City, Louisiana, 71111
Site 113
Charlotte, North Carolina, 28210
Site 107
Chattanooga, Tennessee, 37421
Site 131
Clearwater, Florida, 33765
Site 153
Cleveland, Ohio, 44195
Site 105
Coral Gables, Florida, 33134
Site 145
Cypress, Texas, 77429
Site 132
Dallas, Texas, 75224
Site 109
Fayetteville, Georgia, 30214
Site 130
Fayetteville, North Carolina, 28304
Site 112
Forest, Virginia, 24551
Site 108
Greenacres City, Florida, 33467
Site 140
Greensboro, North Carolina, 27408
Site 154
Hammond, Louisiana, 70403
Site 141
Jamaica, New York, 11432
Site 116
Jefferson City, Missouri, 65109
Site 134
Jupiter, Florida, 33458
Site 120
Kingsport, Tennessee, 37660
Site 123
Las Vegas, Nevada, 89121
Site 125
Lawrenceville, Georgia, 30044
Site 103
Lincoln, California, 95648
Site 124
McKinney, Texas, 75071
Site 147
Mesquite, Texas, 75149
Site 146
Miami, Florida, 33126
Site 137
Miami, Florida, 33135
Site 139
Miami, Florida, 33135
Site 143
Miami, Florida, 33144
Site 104
Morgantown, North Carolina, 28655
Site 152
Nashville, Tennessee, 37232
Site 126
Pearland, Texas, 77584
Site 122
Pembroke Pines, Florida, 33026
Site 150
Raleigh, North Carolina, 27612
Site 115
Rapid City, South Dakota, 57702
Site 128
Richland Hills, Texas, 76180
Site 148
Shreveport, Louisiana, 71105
Site 114
Slidell, Louisiana, 70458
Site 121
St Louis, Missouri, 63141
Site 102
Tampa, Florida, 91303
Site 129
Torrance, California, 90502
Site 135
Tustin, California, 92780

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Dose-ranging, Multicenter Phase 2 Study to Evaluate the Safety, Efficacy, and Tolerability of MLS-101 in Subjects 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

Conditions: Hypertension, Renal
Being tested: MLS-101 (Part I), Placebo (Part I), Placebo (Part II), MLS-101 (Part II)
Keywords: Blood pressure, Uncontrolled hypertension, Phase II
Medical subject headings: Hypertension, Renal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MLS-101 (Part I)Drug
MLS-101 tablet(s) by mouth once or twice daily.
Placebo (Part I)Other
Placebo tablet(s) by mouth once or twice daily.
Placebo (Part II)Other
Placebo tablet(s) by mouth once daily.
MLS-101 (Part II)Drug
MLS-101 tablet(s) by mouth once daily.

Study groups in NCT05001945
Study group	Role	What they receive
Placebo (Part I)	Placebo comparator	Placebo tablet(s) by mouth once or twice daily. Receives: Other: Placebo (Part I)
Dose 1 (Part I)	Experimental	MLS-101 tablet(s) by mouth once or twice daily. Receives: Drug: MLS-101 (Part I)
Dose 2 (Part I)	Experimental	MLS-101 tablet(s) by mouth once or twice daily. Receives: Drug: MLS-101 (Part I)
Dose 3 (Part I)	Experimental	MLS-101 tablet(s) by mouth once or twice daily. Receives: Drug: MLS-101 (Part I)
Placebo (Part II)	Placebo comparator	Placebo tablet(s) by mouth once daily. Receives: Other: Placebo (Part II)
Dose (Part II)	Experimental	MLS-101 tablet(s) by mouth once daily. Receives: Drug: MLS-101 (Part II)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Office-measured Systolic Blood Pressure (SBP) at Study Week 8 Compared to Placebo
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 group and the placebo group is provided for Week 8.
Measured: 8 Weeks

Secondary outcomes (3)

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)
The ABPM SBP was measured at baseline and EoT. Change in ABPM-derived mean SBP and DBP from baseline to EoT was analyzed using an ANCOVA with a term for treatment group and a baseline mean 24-hour value as a covariate.
Measured: 8 Weeks
Week 8 Change From Baseline in Office-measured Diastolic Blood Pressure (DBP)
Change in office-measured (average of last 2 of 5 unattended measurements using an automated oscillometric sphygmomanometer device after approximately 5 minutes of rest in the seated position) DBP from baseline to the end of study at week 8.
Measured: 8 weeks
Number of Participants With Blood Pressure ≤ 130/80 mmHg at Week 8
Each participant was assessed as a success if the Week 8 value for SBP was ≤130 mmHg and DBP ≤80 mmHg; subjects not meeting both these thresholds were assessed as a failure. Subjects missing an assessment at Week 8 or who received rescue medications were also considered failures.
Measured: 8 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 20217 Oct 2022

First posted12 Aug 2021
Study start1 Jul 2021
Primary completion7 Sep 2022
Study completion7 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hypertension, RenalStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05001945
Sponsor's protocol ID: MLS-101-201
Acronym: Target-HTN
Status last verified: Jan 2024
First submitted: 20 Jul 2021
Last updated: 5 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Laffin LJ, Rodman D, Luther JM, Vaidya A, Weir MR, Rajicic N, Slingsby BT, Nissen SE; Target-HTN Investigators. Aldosterone Synthase Inhibition With Lorundrostat for Uncontrolled Hypertension: The Target-HTN Randomized Clinical Trial. JAMA. 2023 Sep 26;330(12):1140-1150. doi: 10.1001/jama.2023.16029.
PubMed 37690061

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Dose-ranging, Multicenter Phase 2 Study to Evaluate the Safety, Efficacy, and Tolerability of MLS-101 in Subjects With Uncontrolled Hypertension
ClinicalTrials.gov ID: NCT05001945
Acronym / sponsor ID: Target-HTN / MLS-101-201
Conditions: Hypertension, Renal
Keywords: Blood pressure, Uncontrolled hypertension, Phase II
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Mineralys Therapeutics Inc.Industry (pharma, biotech, devices)
Study start: 1 Jul 2021 (actual)
Primary completion: 7 Sep 2022 (actual)
Study completion: 7 Oct 2022 (actual)
First posted: 12 Aug 2021 (actual)
Results: Posted 5 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Placebo (Part I)	Placebo comparator	Other: Placebo (Part I)Placebo tablet(s) by mouth once or twice daily.
Dose 1 (Part I)	Experimental	Drug: MLS-101 (Part I)MLS-101 tablet(s) by mouth once or twice daily.
Dose 2 (Part I)	Experimental	Drug: MLS-101 (Part I)MLS-101 tablet(s) by mouth once or twice daily.
Dose 3 (Part I)	Experimental	Drug: MLS-101 (Part I)MLS-101 tablet(s) by mouth once or twice daily.
Placebo (Part II)	Placebo comparator	Other: Placebo (Part II)Placebo tablet(s) by mouth once daily.
Dose (Part II)	Experimental	Drug: MLS-101 (Part II)MLS-101 tablet(s) by mouth once daily.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Male and nonpregnant, nonlactating female subjects ≥ 18 years of age.
Written informed consent Health Insurance Portability and Accountability Act authorization, and local patient privacy required documentation for this study have been obtained
Automated office blood pressure (AOBP) with SBP ≥ 130 mm Hg
Background antihypertensive treatment of ≥ 2 drugs
Serum cortisol ≥ 18 mcg/dL

Key exclusion criteria (26 listed)

1. Concomitant use of epithelial sodium channel inhibitors or mineralocorticoid receptor antagonists
3. Subjects with hypokalemia
4. Subjects with hyperkalemia
5. Subjects with serum cortisol < 3 mcg/dL
6. Subjects with serum sodium < 135 mEq/L

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MLS-101 (Part I)MLS-101 tablet(s) by mouth once or twice daily.	Drug	Dose 1 (Part I), Dose 2 (Part I), Dose 3 (Part I)
Placebo (Part I)Placebo tablet(s) by mouth once or twice daily.	Other	Placebo (Part I)
Placebo (Part II)Placebo tablet(s) by mouth once daily.	Other	Placebo (Part II)
MLS-101 (Part II)MLS-101 tablet(s) by mouth once daily.	Drug	Dose (Part II)

Primary outcome

Change From Baseline in Office-measured Systolic Blood Pressure (SBP) at Study Week 8 Compared to Placebo
Time frame: 8 Weeks
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 group and the placebo group is provided for Week 8.

3 secondary outcomes

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)
Time frame: 8 Weeks
Week 8 Change From Baseline in Office-measured Diastolic Blood Pressure (DBP)
Time frame: 8 weeks
Number of Participants With Blood Pressure ≤ 130/80 mmHg at Week 8
Time frame: 8 Weeks

Results and safety

Results posted to the registry on 5 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo - Part 1	30	29
Lorundrostat 12.5 mg BID - Part 1	22	18
Lorundrostat 25 mg BID - Part 1	30	28
Lorundrostat 12.5 mg QD - Part 1	23	18
Lorundrostat 50 mg QD - Part 1	28	26
Lorundrostat 100 mg QD - Part 1	30	27
Placebo - Part 2	6	6
Lorundrostat 100 mg QD - Part 2	31	30

Primary outcome: Change From Baseline in Office-measured Systolic Blood Pressure (SBP) at Study Week 8 Compared to Placebo

Time frame: 8 Weeks. Least squares mean (Standard Error). Unit: mmHg

Measure	Placebo - Part 1 n = 29	Lorundrostat 12.5 mg BID - Part 1 n = 19	Lorundrostat 25 mg BID - Part 1 n = 28	Lorundrostat 12.5 mg QD - Part 1 n = 19	Lorundrostat 50 mg QD - Part 1 n = 28	Lorundrostat 100 mg QD - Part 1 n = 25	Placebo - Part 2 n = 0	Lorundrostat 100 mg QD - Part 2 n = 31
Value	-4.10 (2.62)	-11.3 (3.15)	-11.07 (2.65)	-5.63 (3.16)	-13.69 (2.67)	-11.92 (2.77)	–	-11.43 (2.41)

Population analysed: The full analysis set included all randomized subjects who received at least 1 dose of randomized study treatment (lorundrostat or placebo). Subjects were analyzed according to the randomized study treatment group. Per the study SAP, modelled analysis comparisons for Part 2 were performed for 100 mg QD Part 2 vs 100mg QD Part 1, and not to Placebo - Part 2. Accordingly, while subjects were analyzed, modelled LSmeans for Placebo - Part 2 were not reported.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo - Part 1	0 of 30 (0%)	7 of 30 (23.3%)	0 of 30
Lorundrostat 12.5 mg BID - Part 1	0 of 22 (0%)	13 of 22 (59.1%)	0 of 22
Lorundrostat 25 mg BID - Part 1	0 of 30 (0%)	18 of 30 (60%)	0 of 30
Lorundrostat 12.5 mg QD - Part 1	2 of 23 (8.7%)	16 of 23 (69.6%)	0 of 23
Lorundrostat 50 mg QD - Part 1	0 of 28 (0%)	10 of 28 (35.7%)	0 of 28
Lorundrostat 100 mg QD - Part 1	0 of 30 (0%)	16 of 30 (53.3%)	0 of 30
Placebo - Part 2	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Lorundrostat 100 mg QD - Part 2	1 of 31 (3.2%)	19 of 31 (61.3%)	0 of 31
Run-in	0 of 305 (0%)	8 of 305 (2.6%)	0 of 305

Limitations and caveats (from the sponsor): Following the completion of the planned interim analysis in January 2022, the two lowest doses in Part 1 (i.e., 12.5 mg QD and 12.5 mg BID) were dropped from the study and no further subjects were enrolled in these treatment arms. Accordingly, overall subject numbers in these arms is less than originally planned.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37690061Laffin LJ, Rodman D, Luther JM, Vaidya A, Weir MR, Rajicic N, Slingsby BT, Nissen SE; Target-HTN Investigators. Aldosterone Synthase Inhibition With Lorundrostat for Uncontrolled Hypertension: The Target-HTN Randomized Clinical Trial. JAMA. 2023 Sep 26;330(12):1140-1150. doi: 10.1001/jama.2023.16029.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

44 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MLS-101 (Part I) and MLS-101 (Part II) in people with Hypertension, Renal, run by Mineralys Therapeutics Inc. at 44 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Office-measured Systolic Blood Pressure (SBP) at Study Week 8 Compared to Placebo (time frame: 8 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05001945, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.