A Study of VERVE-102 (LY4636581) in Adults With or at High Risk for Cardiovascular Disease
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorVerve Therapeutics, Inc.
About this trial
The purpose of this study is to measure the change in bad cholesterol (LDL-C) with VERVE-102 compared to placebo in adults who have plaque buildup in their arteries or are at high risk of developing it.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Established atherosclerotic cardiovascular disease (ASCVD) and/or at a high risk of ASCVD
Disqualifiers
History of confirmed or suspected homozygous familial hypercholesterolemia (HoFH)
Chronic liver disease
Current treatment with PCSK9 inhibitor or prior treatment within specified timeframe
Trial design
Design model
Parallel
Treatments tested in this trial
VERVE-102
DrugAdministered IV
Placebo
DrugAdministered IV
Treatment groups
175 Participants
are divided into 4 treatment groupsGroup A: VERVE-102 Dose 1Experimental treatment 1 intervention
Group B: VERVE-102 Dose 2Experimental treatment 1 intervention
Group C: VERVE-102 Dose 3Experimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percent Change from Baseline in LDL-C
Time frame
Baseline, Day 90Secondary outcomes
1
Percent Change from Baseline in LDL-C
Time frame
Baseline to End of Study (up to Day 365)2
Percent Change from Baseline in Circulating Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
Time frame
Baseline to End of Study (up to Day 365)3
Percent Change from Baseline Total Cholesterol
Time frame
Baseline to End of Study (up to Day 365)4
Percent Change from Baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C)
Time frame
Baseline to End of Study (up to Day 365)Sponsors and contacts
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Source ClinicalTrials.gov
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