BioinvestGPT ApS · Research use only

NCT06785454 (Lorundrostat in Obstructive Sleep Apnea Hypertension): BVCT ex-ante prediction vs. reported outcome

On 16 Nov 2025, BioinvestGPT's BVCT predicted technical success and commercial partial success for this trial. The 9 Mar 2026 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient (inferior to tirzepatide).

Clinical Trial

Acronym
EXPLORE-OSA
Drug Name
Lorundrostat
Drug MoA
selective aldosterone synthase inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Cardiovascular Diseases
Indication
Obstructive Sleep Apnea Hypertension
Human Patients
48
Sponsor
Mineralys Therapeutics
Phase
Phase 2

Prediction of , index 2093

Prospective Prediction
Prediction Index
2093
Prediction Date
Commercial Prediction
partial SUCCESS (commercially maybe sufficient yet moderate clinical benefit in AHI moderately superior to PAP therapy, moderately inferior to tirzepatide, and moderately-to-strongly inferior to retatrutide)
Technical Prediction
SUCCESS (statistically significant clinical benefit in AHI compared with placebo with a negative dose-response relationship)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
113 days in advance
Readout Data Interpretation
Lorundrostat did not achieve statistically significant placebo-adjusted AHI reduction at week 4, which is inferior to 20 to 23.8 placebo-adjusted AHI reduction (p<0.001) achieved by tirzepatide (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient (inferior to tirzepatide)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 2, Multicenter, Randomized, Double Blind, Placebo Controlled, Crossover Study to Evaluate the Efficacy and Safety of Lorundrostat in Participants With Moderate to Severe Obstructive Sleep Apnea and Hypertension
Phase
Phase 2
Status
Completed
Enrollment
48
Lead sponsor
Mineralys Therapeutics Inc.
Conditions
Obstructive Sleep Apnea; Hypertension
Interventions
DRUG: Lorundrostat; DRUG: Placebo
Design
Randomized · Crossover · Double
Primary purpose
Treatment
Start
2025-02-28
Primary completion
2025-12-17
Completion
2025-12-29
Primary outcomes
  • Placebo-adjusted Change From Baseline in AHI at Week 4 (Baseline, Week 4)

NCT06785454 on ClinicalTrials.gov

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