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NCT06164730 (VERVE102 in heterozygous familial hypercholesterolemia and/or premature coronary…): BVCT ex-ante prediction vs. reported outcome

On 9 Nov 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 14 Apr 2025 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
NCT06164730
Acronym
Heart-2
Drug Name
VERVE102
Drug MoA
LNP-delivered GalNAc-conjugated anti-PCSK9 base editing gene therapy
Drug Modality
gene therapy
Drug Class
First-In-Class
Therapeutic Area
Nutritional and Metabolic Diseases
Indication
heterozygous familial hypercholesterolemia (HeFH) and/or premature coronary artery disease (CAD)
Human Patients
36
Sponsor
Verve Therapeutics
Phase
Phase 1

Prediction of , index 1830

Prospective Prediction
Prediction Index
1830
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in lowering LDL-C due to non-superior-to-SoC efficacy and inferior-to-SoC toxicity; despite the superiority of VERVE-102 over VERVE-101)
Technical Prediction
partial SUCCESS (statistically significant yet moderate clinical benefit in lowering LDL-C)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
156 days in advance
Readout Data Interpretation
VERVE102 achieved a mean reduction in blood LDL-C of 53% without any SAEs; which is inferior to the 76% LDL-C reduction achieved by evolocumab (see add'l link below); and superior to VERVE101 that has one grade 3 TEAE
Press Release
Additional Readout Data
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
Open-label, Phase 1b, Single Ascending Dose Study to Evaluate the Safety of VERVE-102 Administered to Patients With Heterozygous Familial Hypercholesterolemia or Premature Coronary Artery Disease Who Require Additional Lowering of Low-density Lipoprotein Cholesterol
Phase
Phase 1
Status
Recruiting
Enrollment
85
Lead sponsor
Verve Therapeutics, Inc.
Conditions
Heterozygous Familial Hypercholesterolemia; Premature Coronary Heart Disease
Interventions
DRUG: VERVE-102
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2024-04-30
Primary completion
2026-10
Completion
2027-10
Primary outcomes
  • Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) (up to Day 365)

NCT06164730 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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