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NCT05462756 (LY3209590 in Type 2 Diabetes): BVCT ex-ante prediction vs. reported outcome

On 21 Nov 2022, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 16 May 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

NCTID
NCT05462756
Acronym
QWINT-4
Drug Name
LY3209590
Drug MoA
once-weekly insulin treatment
Drug Modality
protein biologic
Drug Class
Best-In-Class
Therapeutic Area
Nutritional and Metabolic Diseases
Indication
Type 2 Diabetes
Human Patients
730
Sponsor
Eli Lilly and Company
Phase
Phase 3

Prediction of , index 704

Prospective Prediction
Prediction Index
704
Prediction Date
Commercial Prediction
SUCCESS (non-inferior)
Technical Prediction
SUCCESS

Readout of

Prediction Validation
Readout Date
Prediction To Readout
542 days in advance
Readout Data Interpretation
-1.34% (efsitora) vs -1.26% (degludec) HbA1C at week 52; non-inferior.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 3, Parallel-Design, Open-Label, Randomized Controlled Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared to Insulin Glargine in Adults With Type 2 Diabetes on Multiple Daily Injections
Phase
Phase 3
Status
Completed
Enrollment
730
Lead sponsor
Eli Lilly and Company
Conditions
Type 2 Diabetes; Type 2 Diabetes Treated With Insulin
Interventions
DRUG: Insulin Efsitora Alfa; DRUG: Insulin Lispro (U100); DRUG: Insulin Glargine (U100)
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2022-08-11
Primary completion
2024-02-27
Completion
2024-02-27
Results first posted
2025-04-27
Primary outcomes
  • Change From Baseline in Hemoglobin A1c (HbA1c) [Noninferiority] (Baseline, Week 26)

NCT05462756 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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