Trial Outcomes & Findings for Efficacy and Safety of Lorundrostat in Addition to Sodium-Glucose Cotransporter-2 Inhibitors (SGLT2i) in Subjects With Hypertension and Chronic Kidney Disease (CKD) With Albuminuria (NCT NCT06150924)

NCT ID: NCT06150924

Last Updated: 2026-06-03

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

60 participants

Primary outcome timeframe

Baseline to Week 4

Results posted on

2026-06-03

Participant Flow

The study consisted of a Screening period of up to 2-weeks, a 2-week run-in period where subjects either began study provided dapagliflozin 10 mg or continued on their regularly prescribed SGLT2i, and two double-blind 4-week treatment periods separated by a 4-week washout period. Subjects were randomized (1:1) to two treatment sequences: lorundrostat-placebo (LP) and placebo-lorundrostat (PL).

Participant milestones

Participant milestones
Measure	Cohort 1 Period 1 (4 weeks): Lorundrostat 25mg QD + SGLT2i; Washout (4 weeks): Placebo QD + SGLT2i; Period 2 (4 weeks): Placebo QD + SGLT2i	Cohort 2 Period 1 (4 weeks): Placebo QD + SGLT2i; Washout (4 weeks): Placebo QD + SGLT2i; Period 2 (4 weeks): Lorundrostat 25mg QD + SGLT2i
Overall Study STARTED	30	29
Overall Study COMPLETED	29	28
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 Period 1 (4 weeks): Lorundrostat 25mg QD + SGLT2i; Washout (4 weeks): Placebo QD + SGLT2i; Period 2 (4 weeks): Placebo QD + SGLT2i	Cohort 2 Period 1 (4 weeks): Placebo QD + SGLT2i; Washout (4 weeks): Placebo QD + SGLT2i; Period 2 (4 weeks): Lorundrostat 25mg QD + SGLT2i
Overall Study Physician Decision	1	1

Baseline Characteristics

Efficacy and Safety of Lorundrostat in Addition to Sodium-Glucose Cotransporter-2 Inhibitors (SGLT2i) in Subjects With Hypertension and Chronic Kidney Disease (CKD) With Albuminuria

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 n=30 Participants Period 1 (4 weeks): Lorundrostat 25mg QD + SGLT2i; Washout (4 weeks): Placebo QD + SGLT2i; Period 2 (4 weeks): Placebo QD + SGLT2i	Cohort 2 n=29 Participants Period 1 (4 weeks): Placebo QD + SGLT2i; Washout (4 weeks): Placebo QD + SGLT2i; Period 2 (4 weeks): Lorundrostat 25mg QD + SGLT2i	Total n=59 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=20 Participants	13 Participants n=20 Participants	26 Participants n=40 Participants
Age, Categorical >=65 years	17 Participants n=20 Participants	16 Participants n=20 Participants	33 Participants n=40 Participants
Age, Continuous	64.8 Years STANDARD_DEVIATION 11.09 • n=20 Participants	64.3 Years STANDARD_DEVIATION 9.25 • n=20 Participants	64.6 Years STANDARD_DEVIATION 10.14 • n=40 Participants
Sex: Female, Male Female	10 Participants n=20 Participants	8 Participants n=20 Participants	18 Participants n=40 Participants
Sex: Female, Male Male	20 Participants n=20 Participants	21 Participants n=20 Participants	41 Participants n=40 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Asian	0 Participants n=20 Participants	2 Participants n=20 Participants	2 Participants n=40 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants	1 Participants n=20 Participants	1 Participants n=40 Participants
Race (NIH/OMB) Black or African American	4 Participants n=20 Participants	6 Participants n=20 Participants	10 Participants n=40 Participants
Race (NIH/OMB) White	21 Participants n=20 Participants	18 Participants n=20 Participants	39 Participants n=40 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=20 Participants	2 Participants n=20 Participants	7 Participants n=40 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=20 Participants	10 Participants n=20 Participants	25 Participants n=40 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=20 Participants	18 Participants n=20 Participants	32 Participants n=40 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=20 Participants	1 Participants n=20 Participants	2 Participants n=40 Participants
Region of Enrollment United States	30 Participants n=20 Participants	29 Participants n=20 Participants	59 Participants n=40 Participants
Seated Automated Office Blood Pressure (AOBP), Systolic	147.008 mmHg STANDARD_DEVIATION 9.8704 • n=20 Participants	150.802 mmHg STANDARD_DEVIATION 10.6962 • n=20 Participants	148.873 mmHg STANDARD_DEVIATION 10.3731 • n=40 Participants

PRIMARY outcome

Timeframe: Baseline to Week 4

Outcome measures

Outcome measures
Measure	Placebo n=58 Participants Placebo, pooled across both randomization sequence cohorts	Lorundrostat n=58 Participants Lorundrostat, pooled across both randomization sequence cohorts
Placebo-adjusted Change From Baseline in Automated Office Blood Pressure (AOBP) Systolic Blood Pressure (SBP) at Week 4	-1.755 mmHg Interval -4.966 to 1.455	-9.253 mmHg Interval -12.453 to -6.053

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Lorundrostat

Serious events: 2 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=57 participants at risk Placebo, pooled across both randomization sequence cohorts	Lorundrostat n=58 participants at risk Lorundrostat, pooled across both randomization sequence cohorts
Infections and infestations Influenza	0.00% 0/57 • All adverse events (AEs) and serious adverse events (SAEs) will be collected from signing of the ICF to end of follow up. Adverse events that occurred during the Washout Period were attributed to treatment administered during Treatment Period 1. Adverse events that occurred during the Safety Follow-up Period were considered TEAEs if they occurred within 14 days of the start of the Safety Follow-up Period and were attributed to administered during Treatment Period 2.	1.7% 1/58 • All adverse events (AEs) and serious adverse events (SAEs) will be collected from signing of the ICF to end of follow up. Adverse events that occurred during the Washout Period were attributed to treatment administered during Treatment Period 1. Adverse events that occurred during the Safety Follow-up Period were considered TEAEs if they occurred within 14 days of the start of the Safety Follow-up Period and were attributed to administered during Treatment Period 2.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/57 • All adverse events (AEs) and serious adverse events (SAEs) will be collected from signing of the ICF to end of follow up. Adverse events that occurred during the Washout Period were attributed to treatment administered during Treatment Period 1. Adverse events that occurred during the Safety Follow-up Period were considered TEAEs if they occurred within 14 days of the start of the Safety Follow-up Period and were attributed to administered during Treatment Period 2.	1.7% 1/58 • All adverse events (AEs) and serious adverse events (SAEs) will be collected from signing of the ICF to end of follow up. Adverse events that occurred during the Washout Period were attributed to treatment administered during Treatment Period 1. Adverse events that occurred during the Safety Follow-up Period were considered TEAEs if they occurred within 14 days of the start of the Safety Follow-up Period and were attributed to administered during Treatment Period 2.
Renal and urinary disorders Acute kidney injury	0.00% 0/57 • All adverse events (AEs) and serious adverse events (SAEs) will be collected from signing of the ICF to end of follow up. Adverse events that occurred during the Washout Period were attributed to treatment administered during Treatment Period 1. Adverse events that occurred during the Safety Follow-up Period were considered TEAEs if they occurred within 14 days of the start of the Safety Follow-up Period and were attributed to administered during Treatment Period 2.	1.7% 1/58 • All adverse events (AEs) and serious adverse events (SAEs) will be collected from signing of the ICF to end of follow up. Adverse events that occurred during the Washout Period were attributed to treatment administered during Treatment Period 1. Adverse events that occurred during the Safety Follow-up Period were considered TEAEs if they occurred within 14 days of the start of the Safety Follow-up Period and were attributed to administered during Treatment Period 2.

Other adverse events

Other adverse events
Measure	Placebo n=57 participants at risk Placebo, pooled across both randomization sequence cohorts	Lorundrostat n=58 participants at risk Lorundrostat, pooled across both randomization sequence cohorts
Metabolism and nutrition disorders Diabetes mellitus	3.5% 2/57 • All adverse events (AEs) and serious adverse events (SAEs) will be collected from signing of the ICF to end of follow up. Adverse events that occurred during the Washout Period were attributed to treatment administered during Treatment Period 1. Adverse events that occurred during the Safety Follow-up Period were considered TEAEs if they occurred within 14 days of the start of the Safety Follow-up Period and were attributed to administered during Treatment Period 2.	0.00% 0/58 • All adverse events (AEs) and serious adverse events (SAEs) will be collected from signing of the ICF to end of follow up. Adverse events that occurred during the Washout Period were attributed to treatment administered during Treatment Period 1. Adverse events that occurred during the Safety Follow-up Period were considered TEAEs if they occurred within 14 days of the start of the Safety Follow-up Period and were attributed to administered during Treatment Period 2.
Metabolism and nutrition disorders Hyperkalaemia	3.5% 2/57 • All adverse events (AEs) and serious adverse events (SAEs) will be collected from signing of the ICF to end of follow up. Adverse events that occurred during the Washout Period were attributed to treatment administered during Treatment Period 1. Adverse events that occurred during the Safety Follow-up Period were considered TEAEs if they occurred within 14 days of the start of the Safety Follow-up Period and were attributed to administered during Treatment Period 2.	15.5% 9/58 • All adverse events (AEs) and serious adverse events (SAEs) will be collected from signing of the ICF to end of follow up. Adverse events that occurred during the Washout Period were attributed to treatment administered during Treatment Period 1. Adverse events that occurred during the Safety Follow-up Period were considered TEAEs if they occurred within 14 days of the start of the Safety Follow-up Period and were attributed to administered during Treatment Period 2.
Metabolism and nutrition disorders Hyponatraemia	5.3% 3/57 • All adverse events (AEs) and serious adverse events (SAEs) will be collected from signing of the ICF to end of follow up. Adverse events that occurred during the Washout Period were attributed to treatment administered during Treatment Period 1. Adverse events that occurred during the Safety Follow-up Period were considered TEAEs if they occurred within 14 days of the start of the Safety Follow-up Period and were attributed to administered during Treatment Period 2.	5.2% 3/58 • All adverse events (AEs) and serious adverse events (SAEs) will be collected from signing of the ICF to end of follow up. Adverse events that occurred during the Washout Period were attributed to treatment administered during Treatment Period 1. Adverse events that occurred during the Safety Follow-up Period were considered TEAEs if they occurred within 14 days of the start of the Safety Follow-up Period and were attributed to administered during Treatment Period 2.
Investigations Glomerular filtration rate decreased	3.5% 2/57 • All adverse events (AEs) and serious adverse events (SAEs) will be collected from signing of the ICF to end of follow up. Adverse events that occurred during the Washout Period were attributed to treatment administered during Treatment Period 1. Adverse events that occurred during the Safety Follow-up Period were considered TEAEs if they occurred within 14 days of the start of the Safety Follow-up Period and were attributed to administered during Treatment Period 2.	10.3% 6/58 • All adverse events (AEs) and serious adverse events (SAEs) will be collected from signing of the ICF to end of follow up. Adverse events that occurred during the Washout Period were attributed to treatment administered during Treatment Period 1. Adverse events that occurred during the Safety Follow-up Period were considered TEAEs if they occurred within 14 days of the start of the Safety Follow-up Period and were attributed to administered during Treatment Period 2.
Infections and infestations Upper respiratory tract infection	3.5% 2/57 • All adverse events (AEs) and serious adverse events (SAEs) will be collected from signing of the ICF to end of follow up. Adverse events that occurred during the Washout Period were attributed to treatment administered during Treatment Period 1. Adverse events that occurred during the Safety Follow-up Period were considered TEAEs if they occurred within 14 days of the start of the Safety Follow-up Period and were attributed to administered during Treatment Period 2.	3.4% 2/58 • All adverse events (AEs) and serious adverse events (SAEs) will be collected from signing of the ICF to end of follow up. Adverse events that occurred during the Washout Period were attributed to treatment administered during Treatment Period 1. Adverse events that occurred during the Safety Follow-up Period were considered TEAEs if they occurred within 14 days of the start of the Safety Follow-up Period and were attributed to administered during Treatment Period 2.
Vascular disorders Diastolic hypotension	1.8% 1/57 • All adverse events (AEs) and serious adverse events (SAEs) will be collected from signing of the ICF to end of follow up. Adverse events that occurred during the Washout Period were attributed to treatment administered during Treatment Period 1. Adverse events that occurred during the Safety Follow-up Period were considered TEAEs if they occurred within 14 days of the start of the Safety Follow-up Period and were attributed to administered during Treatment Period 2.	3.4% 2/58 • All adverse events (AEs) and serious adverse events (SAEs) will be collected from signing of the ICF to end of follow up. Adverse events that occurred during the Washout Period were attributed to treatment administered during Treatment Period 1. Adverse events that occurred during the Safety Follow-up Period were considered TEAEs if they occurred within 14 days of the start of the Safety Follow-up Period and were attributed to administered during Treatment Period 2.
Vascular disorders Hypotension	3.5% 2/57 • All adverse events (AEs) and serious adverse events (SAEs) will be collected from signing of the ICF to end of follow up. Adverse events that occurred during the Washout Period were attributed to treatment administered during Treatment Period 1. Adverse events that occurred during the Safety Follow-up Period were considered TEAEs if they occurred within 14 days of the start of the Safety Follow-up Period and were attributed to administered during Treatment Period 2.	5.2% 3/58 • All adverse events (AEs) and serious adverse events (SAEs) will be collected from signing of the ICF to end of follow up. Adverse events that occurred during the Washout Period were attributed to treatment administered during Treatment Period 1. Adverse events that occurred during the Safety Follow-up Period were considered TEAEs if they occurred within 14 days of the start of the Safety Follow-up Period and were attributed to administered during Treatment Period 2.
Vascular disorders Orthostatic hypotension	1.8% 1/57 • All adverse events (AEs) and serious adverse events (SAEs) will be collected from signing of the ICF to end of follow up. Adverse events that occurred during the Washout Period were attributed to treatment administered during Treatment Period 1. Adverse events that occurred during the Safety Follow-up Period were considered TEAEs if they occurred within 14 days of the start of the Safety Follow-up Period and were attributed to administered during Treatment Period 2.	3.4% 2/58 • All adverse events (AEs) and serious adverse events (SAEs) will be collected from signing of the ICF to end of follow up. Adverse events that occurred during the Washout Period were attributed to treatment administered during Treatment Period 1. Adverse events that occurred during the Safety Follow-up Period were considered TEAEs if they occurred within 14 days of the start of the Safety Follow-up Period and were attributed to administered during Treatment Period 2.
Renal and urinary disorders Renal and urinary disorders	0.00% 0/57 • All adverse events (AEs) and serious adverse events (SAEs) will be collected from signing of the ICF to end of follow up. Adverse events that occurred during the Washout Period were attributed to treatment administered during Treatment Period 1. Adverse events that occurred during the Safety Follow-up Period were considered TEAEs if they occurred within 14 days of the start of the Safety Follow-up Period and were attributed to administered during Treatment Period 2.	5.2% 3/58 • All adverse events (AEs) and serious adverse events (SAEs) will be collected from signing of the ICF to end of follow up. Adverse events that occurred during the Washout Period were attributed to treatment administered during Treatment Period 1. Adverse events that occurred during the Safety Follow-up Period were considered TEAEs if they occurred within 14 days of the start of the Safety Follow-up Period and were attributed to administered during Treatment Period 2.
Musculoskeletal and connective tissue disorders Muscle spasms	3.5% 2/57 • All adverse events (AEs) and serious adverse events (SAEs) will be collected from signing of the ICF to end of follow up. Adverse events that occurred during the Washout Period were attributed to treatment administered during Treatment Period 1. Adverse events that occurred during the Safety Follow-up Period were considered TEAEs if they occurred within 14 days of the start of the Safety Follow-up Period and were attributed to administered during Treatment Period 2.	1.7% 1/58 • All adverse events (AEs) and serious adverse events (SAEs) will be collected from signing of the ICF to end of follow up. Adverse events that occurred during the Washout Period were attributed to treatment administered during Treatment Period 1. Adverse events that occurred during the Safety Follow-up Period were considered TEAEs if they occurred within 14 days of the start of the Safety Follow-up Period and were attributed to administered during Treatment Period 2.
Nervous system disorders Nervous system disorders	1.8% 1/57 • All adverse events (AEs) and serious adverse events (SAEs) will be collected from signing of the ICF to end of follow up. Adverse events that occurred during the Washout Period were attributed to treatment administered during Treatment Period 1. Adverse events that occurred during the Safety Follow-up Period were considered TEAEs if they occurred within 14 days of the start of the Safety Follow-up Period and were attributed to administered during Treatment Period 2.	3.4% 2/58 • All adverse events (AEs) and serious adverse events (SAEs) will be collected from signing of the ICF to end of follow up. Adverse events that occurred during the Washout Period were attributed to treatment administered during Treatment Period 1. Adverse events that occurred during the Safety Follow-up Period were considered TEAEs if they occurred within 14 days of the start of the Safety Follow-up Period and were attributed to administered during Treatment Period 2.

Additional Information

David Rodman, MD Chief Medical Officer

Mineralys Therapeutics

Phone: 1-888-378-6240

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee No unpublished multi-center information may be disclosed without prior written approval from Mineralys unless no multi-center publication is submitted within eighteen (18) months of study closure.
Publication restrictions are in place

Restriction type: OTHER