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NCT05232071 (Lanifibranor Placebo Empagliflozin in NASH and Type 2 Diabetes Mellitus): BVCT ex-ante prediction vs. reported outcome

On 2 Dec 2023, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 18 Mar 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient.

Clinical Trial

NCTID
NCT05232071
Acronym
LEGEND
Drug Name
Lanifibranor (IVA337) Placebo Empagliflozin
Drug MoA
pan-PPAR agonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nutritional and Metabolic Diseases
Indication
NASH and Type 2 Diabetes Mellitus
Human Patients
42
Sponsor
Inventiva Pharma
Phase
Phase 2

Prediction of , index 1370

Prospective Prediction
Prediction Index
1370
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit for lanifibranor + empagliflozin; inferior to tirzepatide)
Technical Prediction
partial SUCCESS (statistically significant yet moderate clinical benefit for lanifibranor + empagliflozin)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
107 days in advance
Readout Data Interpretation
-1.15% & -1.6% HbA1c (mono and combo) at week 24; inferior to the SoC tirzepatide -1.6-2.4% HbA1c at week 26.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With the Sodium-glucose Transport Protein 2 (SGLT2) Inhibitor EmpaGliflozin in patiEnts With Non-alcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)
Phase
Phase 2
Status
Completed
Enrollment
39
Lead sponsor
Inventiva Pharma
Conditions
NASH - Nonalcoholic Steatohepatitis; Diabetes Mellitus, Type 2
Interventions
DRUG: Lanifibranor; DRUG: Placebo; DRUG: Empagliflozin
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2022-06-29
Primary completion
2024-05-08
Completion
2024-06-04
Results first posted
2026-09-09
Primary outcomes
  • Absolute Change in HbA1c (From Baseline to Week 24)

NCT05232071 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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