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NCT06153693 (Lorundrostat in Uncontrolled and Resistant Hypertension): BVCT ex-ante prediction vs. reported outcome

On 26 Jul 2024, BioinvestGPT's BVCT predicted technical partial success and commercial partial success for this trial. The 10 Mar 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient for mix patients.

Clinical Trial

NCTID
NCT06153693
Acronym
Launch-HTN
Drug Name
Lorundrostat
Drug MoA
aldosterone synthase inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Cardiovascular Diseases
Indication
Uncontrolled and Resistant Hypertension
Human Patients
1083
Sponsor
Mineralys Therapeutics
Phase
Phase 3

Prediction of , index 1394

Prospective Prediction
Prediction Index
1394
Prediction Date
Commercial Prediction
partial SUCCESS (commercially maybe sufficient additive clinical benefit in AOBP SBP for the mixed uncontrolled/resistant hypertension patients possibly with poorly controlled obesity/diabetes 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 weak additive clinical benefit in AOBP SBP with a negative dose-response relationship)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
227 days in advance
Readout Data Interpretation
lorundrostat achieved 9.1mmHg (50mg p <0.0001; 50-100mg insignificant) placebo-adjusted AOBP reduction at week 6 featuring a negative dose-response relationship
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient for mix patients
Prediction Classification
True Positive (TP)

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 3 Study to Evaluate the Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension
Phase
Phase 3
Status
Completed
Enrollment
1083
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
2023-11-22
Primary completion
2024-12-10
Completion
2025-01-24
Primary outcomes
  • Change from baseline in automated office BP (AOBP) SBP at Week 6 in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo (Week 6)

NCT06153693 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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