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NCT05989711 (Pemvidutide in Non-Alcoholic Steatohepatitis): BVCT ex-ante prediction vs. reported outcome

On 14 Jan 2025, BioinvestGPT's BVCT predicted technical success and commercial failure for this trial. The 26 Jun 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: partially statistically significant and commercially insufficient.

Clinical Trial

NCTID
NCT05989711
Acronym
IMPACT
Drug Name
Pemvidutide
Drug MoA
GLP1R/GCGR dual agonist
Drug Modality
peptide
Drug Class
First-In-Class
Therapeutic Area
Nutritional and Metabolic Diseases
Indication
Non-Alcoholic Steatohepatitis (NASH)
Human Patients
190
Sponsor
Altimmune
Phase
Phase 2

Prediction of , index 1339

Prospective Prediction
Prediction Index
1339
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in both NASH resolution and fibrosis improvement inferior to tirzepatide)
Technical Prediction
SUCCESS (statistically significant clinical benefit in both NASH resolution and fibrosis improvement compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
163 days in advance
Readout Data Interpretation
pemvidutide achieved 8.6% placebo-adjusted fibrosis improvement with no worsening of steatohepatitis (statistically insignificant) and 33% placebo-adjusted steatohepatitis resolution with no worsening of fibrosis (p<0.0001 at week 24; inferior to tirzepatide's 21% and 52% delta at week 52 (see add'l link below); and inferior to efruxifermin's 21% and 61% delta at week 24 (see DOI-10.1001/jamanetworkopen.2022.31982)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
partially 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 Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Pemvidutide in Non-Cirrhotic Subjects With Nonalcoholic Steatohepatitis (NASH)
Phase
Phase 2
Status
Completed
Enrollment
212
Lead sponsor
Altimmune, Inc.
Conditions
Non-Alcoholic Steatohepatitis (NASH)
Interventions
DRUG: Pemvidutide; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2023-07-27
Primary completion
2025-11-25
Completion
2025-11-25
Primary outcomes
  • Proportion of subjects achieving NASH resolution (NAFLD activity score [NAS], ballooning = 0; lobular inflammation = 0, 1) with at least a 2-point reduction in NAS without worsening of fibrosis (24 weeks)
  • Proportion of subjects achieving at least 1 stage improvement in liver fibrosis without worsening of NASH (defined as no change in the NAS, ie, the sum score for ballooning, inflammation, and steatosis) (24 weeks)
  • Incidence of Treatment Emergent Adverse Events (52 weeks)

NCT05989711 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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