Phase 1b Study of VERVE-201 in Patients With Refractory Hyperlipidemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorVerve Therapeutics, Inc.
About this trial
VT-20101 is an Open-label, Phase 1b, Single-ascending dose study that will evaluate the safety of VERVE-201 administered to patients with Refractory Hyperlipidemia.
VERVE-201 uses base-editing technology designed to inactivate the expression of the ANGPTL3 gene in the liver and lower circulating low-density lipoprotein cholesterol (LDL-C) and triglycerides. This study is designed to determine the safety and pharmacodynamic profile of VERVE-201 in this patient population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Refractory hypercholesterolemia
Refractory hypertriglyceridemia
Disqualifiers
Active or history of chronic liver disease
Current treatment with monoclonal antibody targeting ANGPTL3 or prior treatment within specified timeframe
Clinically significant or abnormal laboratory values as defined by the protocol
Trial design
Design model
Sequential
Treatments tested in this trial
VERVE-201
DrugIntravenous (IV) infusion
Treatment groups
36 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Cohort 1: Single Ascending Dose EscalationExperimental treatment 1 intervention
Group B: Cohort 2: Single Ascending Dose EscalationExperimental treatment 1 intervention
Group C: Cohort 3: Single Ascending Dose EscalationExperimental treatment 1 intervention
Group D: Cohort 4: Single Ascending Dose EscalationExperimental treatment 1 intervention
Group E: Cohort 5: Single Ascending Dose EscalationExperimental treatment 1 intervention
Group F: Cohort 6: Single Ascending Dose EscalationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame
Up to Day 365Secondary outcomes
1
Evaluation of maximum observed concentration (Cmax)
Time frame
Up to Day 3652
Evaluation of time to maximum observed concentration (tmax)
Time frame
Up to Day 3653
Evaluation of terminal elimination half-life (t1/2)
Time frame
Up to Day 3654
Percent and absolute change from baseline in serum ANGPTL3 concentration
Time frame
Up to Day 365Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov