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NCT05769608 (Lorundrostat in uncontrolled hypertension): BVCT ex-ante prediction vs. reported outcome

On 26 Jul 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 29 Mar 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (yet weak efficacy) and commercially insufficient.

Clinical Trial

NCTID
NCT05769608
Acronym
Advance-HTN
Drug Name
Lorundrostat
Drug MoA
aldosterone synthase inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Cardiovascular Diseases
Indication
uncontrolled hypertension
Human Patients
285
Sponsor
Mineralys Therapeutics
Phase
Phase 2

Prediction of , index 1392

Prospective Prediction
Prediction Index
1392
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit in AOBP SBP for the mixed uncontrolled/resistant hypertension patients without further resistance/biomarker-based stratifications; as we predict that lorundrostat (which is non-inferior non-superior to baxdrostat) could deliver commercially sufficient additive clinical benefit only for either resistant hypertension patients or uncontrolled hypertension patients featuring aberrant plasma aldosterone level/aldosterone-to-renin ratio)
Technical Prediction
partial SUCCESS (statistically maybe significant yet very weak additive clinical benefit in ABPM SBP with a negative dose-response relationship)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
246 days in advance
Readout Data Interpretation
lorundrostat achieved 7.9mmHg (50mg p =0.001) or 6.4mmHg (50-100mg p=0.006) placebo-adjusted 24hr ABPM reduction at week 12 featuring a negative dose-response relationship; which is non-superior to 6-12 mmHg placebo-adjusted 24hr ABPM reduction achieved by adding a third therapy to two standard anti-hypertension medications (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (yet weak efficacy) and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Randomized, Double-Blind, Placebo Controlled, Parallel Arm, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled Hypertension on a Standardized Medication Regimen
Phase
Phase 2
Status
Completed
Enrollment
285
Lead sponsor
Mineralys Therapeutics Inc.
Conditions
Hypertension
Interventions
DRUG: Placebo; DRUG: lorundrostat Dose 1; DRUG: lorundrostat Dose 2
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2023-03-13
Primary completion
2025-01-15
Completion
2025-01-15
Primary outcomes
  • Change in 24-hour average ambulatory blood pressure monitoring (ABPM) systolic blood pressure (SBP) (Baseline (Randomization) to Week 12)

NCT05769608 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials