A Phase 1 interventional study of VERVE-201 in Hypercholesterolemia, Hypertriglyceridemia and Refractory Hyperlipidemia, sponsored by Verve Therapeutics, Inc.. Recruiting at 18 sites in 6 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Verve Therapeutics, Inc. (part of Eli Lilly and Company) · Phase 1, Interventional, and Treatment
Cohort 1: Single Ascending Dose Escalation · Cohort 2: Single Ascending Dose Escalation · Cohort 3: Single Ascending Dose Escalation · Cohort 4: Single Ascending Dose Escalation · Cohort 5: Single Ascending Dose Escalation · Cohort 6: Single Ascending Dose Escalation
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.
1,175 studies on the registry are indexed under Hypercholesterolemia; 93 are open to participants now.
This study's planned enrollment of 132 is above the median of 110 across 975 interventional studies indexed under Hypercholesterolemia.
Browse Hypercholesterolemia studies →Verve Therapeutics, Inc. is the lead sponsor of 5 studies on the registry; 4 are open to participants now.
First submitted before Verve Therapeutics, Inc. became part of Eli Lilly and Company.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to a dose-escalation cohort will receive a single dose of VERVE-201.
Drug: VERVE-201
Participants from Part A assigned to the re-dosing cohort will receive a second dose of VERVE-201.
Drug: VERVE-201
Participants assigned to a dose-expansion cohort will receive a single dose of VERVE-201.
Drug: VERVE-201
Intravenous (IV) infusion
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame: Up to Day 365
Evaluation of maximum observed concentration (Cmax)
Time frame: Up to Day 365
Evaluation of time to maximum observed concentration (tmax)
Time frame: Up to Day 365
Evaluation of terminal elimination half-life (t1/2)
Time frame: Up to Day 365
Percent and absolute change from baseline in serum ANGPTL3 concentration
Time frame: Up to Day 365
Percent and absolute change from baseline in serum LDL-C
Time frame: Up to Day 365
Percent and absolute change from baseline in serum triglycerides
Time frame: Up to Day 365
Started Oct 2024 (actual). Primary completion is estimated for Dec 2027, 38 months after the start.
Of 41 industry-sponsored phase 1 interventional studies under Hypercholesterolemia, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 11. This study's planned 38 months is above that.
Counting every sponsor, half of 46 studies reached it within 7 months; a quarter within 2 and three quarters within 10.
How these figures are worked out, and which studies are left out of them.
Cohort 1: Single Ascending Dose Escalation · Cohort 2: Single Ascending Dose Escalation · Cohort 3: Single Ascending Dose Escalation · Cohort 4: Single Ascending Dose Escalation · Cohort 5: Single Ascending Dose Escalation · Cohort 6: Single Ascending Dose Escalation
Cohort 1: Single Ascending Dose Escalation · Cohort 2: Single Ascending Dose Escalation · Cohort 3: Single Ascending Dose Escalation · Cohort 4: Single Ascending Dose Escalation · Cohort 5: Single Ascending Dose Escalation · Cohort 6: Single Ascending Dose Escalation
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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