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NCT05514548 (Monlunabant in Diabetic Kidney Disease): BVCT ex-ante prediction vs. reported outcome

On 17 Jul 2024, BioinvestGPT's BVCT predicted technical partial failure and commercial failure for this trial. The 5 Feb 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05514548
Drug Name
Monlunabant (INV202)
Drug MoA
peripherally selective beta-arrestin-2-biased CB1 inverse agonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Urogenital Diseases
Indication
Diabetic Kidney Disease
Human Patients
265
Sponsor
Novo Nordisk
Phase
Phase 2

Prediction of , index 1683

Prospective Prediction
Prediction Index
1683
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit in eGFR)
Technical Prediction
partial FAILURE (statistically insignificant additive clinical benefit in UACR) partial SUCCESS (statistically significant yet moderate additive clinical benefit in UPCR)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
203 days in advance
Readout Data Interpretation
monlunabant failed to achieve statistical significance in uACR compared with placebo
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant 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, Phase 2 Study of the Efficacy, Safety, and Pharmacokinetics of Two Doses of INV-202 in Patients With Diabetic Kidney Disease
Phase
Phase 2
Status
Completed
Enrollment
265
Lead sponsor
Inversago Pharma Inc.
Conditions
Diabetic Kidney Disease
Interventions
DRUG: INV-202; DRUG: Placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2022-10-19
Primary completion
2024-08-20
Completion
2024-09-03
Primary outcomes
  • Change in UACR from baseline to W16 (16 weeks)

NCT05514548 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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