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NCT04166773 (Tirzepatide in Nonalcoholic Steatohepatitis): BVCT ex-ante prediction vs. reported outcome

On 26 Nov 2022, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 6 Feb 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
NCT04166773
Acronym
SYNERGY-NASH
Drug Name
Tirzepatide (LY3298176)
Drug MoA
GLP1R/GIPR-biased dual agonist
Drug Modality
synthetic peptide
Drug Class
First-In-Class
Therapeutic Area
Nutritional and Metabolic Diseases
Indication
Nonalcoholic Steatohepatitis (NASH)
Human Patients
196
Sponsor
Eli Lilly and Company
Phase
Phase 2

Prediction of , index 709

Prospective Prediction
Prediction Index
709
Prediction Date
Commercial Prediction
SUCCESS
Technical Prediction
SUCCESS

Readout of

Prediction Validation
Readout Date
Prediction To Readout
437 days in advance
Readout Data Interpretation
61% placebo-adjusted absence of NASH with no worsening of fibrosis; which is superior to 16-20% achieved by the SoC resmetirom
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 Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing the Efficacy and Safety of Tirzepatide Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)
Phase
Phase 2
Status
Completed
Enrollment
190
Lead sponsor
Eli Lilly and Company
Conditions
Nonalcoholic Steatohepatitis
Interventions
DRUG: Tirzepatide; DRUG: Placebo
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2019-11-19
Primary completion
2023-12-11
Completion
2024-01-10
Results first posted
2025-01-24
Primary outcomes
  • Percentage of Participants With Absence of Nonalcoholic Steatohepatitis (NASH) With no Worsening of Fibrosis on Liver Histology (Week 52)

NCT04166773 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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