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NCT04822181 (Semaglutide in Non-alcoholic Steatohepatitis): BVCT ex-ante prediction vs. reported outcome

On 24 Mar 2024, BioinvestGPT's BVCT predicted technical success and commercial partial success for this trial. The 1 Nov 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient (inferior to tirzepatide/efruxifermin).

Clinical Trial

NCTID
NCT04822181
Acronym
ESSENCE
Drug Name
Semaglutide
Drug MoA
GLP1R agonist
Drug Modality
peptide
Drug Class
First-In-Class
Therapeutic Area
Nutritional and Metabolic Diseases
Indication
Non-alcoholic Steatohepatitis
Human Patients
1200
Sponsor
Novo Nordisk
Phase
Phase 3

Prediction of , index 1523

Prospective Prediction
Prediction Index
1523
Prediction Date
Commercial Prediction
partial SUCCESS (commercially sufficient yet modest clinical benefit of semaglutide inferior-to-tirzepatide/efruxifermin for non-cirrhotic NASH)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
222 days in advance
Readout Data Interpretation
Semaglutide achieved 14.5% placebo-adjusted fibrosis improvement with no worsening of steatohepatitis and 28.8% placebo-adjusted steatohepatitis resolution with no worsening of fibrosis at week 72; inferior to tirzepatide's 21% and 52% delta at week 52 (DOI- 10.1056/NEJMoa2401943) ; and inferior to efruxifermin's 21% and 61% delta at week 24 (see 10.1001/jamanetworkopen.2022.31982)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially insufficient (inferior to tirzepatide/efruxifermin)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
The Effect of Semaglutide in Subjects With Non-cirrhotic Non-alcoholic Steatohepatitis
Phase
Phase 3
Status
Active not recruiting
Enrollment
1205
Lead sponsor
Novo Nordisk A/S
Conditions
Non-alcoholic Steatohepatitis
Interventions
DRUG: Semaglutide; DRUG: Placebo
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2021-04-01
Primary completion
2029-04-25
Completion
2029-04-25
Primary outcomes
  • Part 1: Resolution of steatohepatitis and no worsening of liver fibrosis (Yes/No) (From randomisation (week 0) to week 72)
  • Part 1: Improvement in liver fibrosis and no worsening of steatohepatitis (Yes/No) (From randomisation (week 0) to week 72)
  • Part 2: Cirrhosis-free survival (Yes/No) (From randomisation (week 0) to week 240)

NCT04822181 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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