Clinical Trials Logo
  1. Home
  2. Hypercholesterolemia
  3. NCT06451770
  4. Details
NCT06451770 Clinical Trial

Phase 1b Study of VERVE-201 in Patients With Refractory Hyperlipidemia

Hypercholesterolemia Clinical Trial

Official title:
A Phase 1b Single Ascending Dose Study to Evaluate the Safety of VERVE-201 in Patients With Refractory Hyperlipidemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06451770
Other study ID # VT-20101
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date December 2024
Est. completion date March 2027

Study information
Verified date June 2024
Source Verve Therapeutics, Inc.
Contact Clinical Development
Phone 781-970-6833
Email verve201clinicaltrials@vervetx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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 Hypercholesterolemia. 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). This study is designed to determine the safety and pharmacodynamic profile of VERVE-201 in this patient population.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 36
Est. completion date March 2027
Est. primary completion date March 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Refractory hypercholesterolemia - Females of non-childbearing potential or males Exclusion Criteria: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• VERVE-201
Intravenous (IV) infusion

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Verve Therapeutics, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) Up to Day 365
Secondary Evaluation of maximum observed concentration (Cmax) Up to Day 365
Secondary Evaluation of time to maximum observed concentration (tmax) Up to Day 365
Secondary Evaluation of terminal elimination half-life (t1/2) Up to Day 365
Secondary Percent and absolute change from baseline in serum ANGPTL3 concentration Up to Day 365
Secondary Percent and absolute change from baseline in serum LDL-C Up to Day 365
See also
  Status Clinical Trial Phase
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Recruiting NCT03947866 - Ezetimibe-Rosuvastatin Evaluation Study
Completed NCT01709513 - Study of Alirocumab (REGN727/SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins (ODYSSEY ALTERNATIVE) Phase 3
Completed NCT01212900 - Randomized Trial of Imaging Versus Risk Factor-Based Therapy for Plaque Regression Phase 4
Completed NCT00001154 - Lipoprotein Metabolism in Normal Volunteers and Patients With High Levels of Lipoproteins
Completed NCT02550288 - A Clinical Trial to Assess the Efficacy and Safety of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-383) Phase 3
Completed NCT03929198 - Translation of Pritikin Program to the Community N/A
Completed NCT04485793 - Effect of a Dietary Supplement on Lipid Pattern and Liver Parameters in Hypercholesterolemia N/A
Completed NCT02341924 - Validating the "Foods for Health" Portfolio of Functional Food Products N/A
Active, not recruiting NCT02223793 - Vascular Lifestyle-Intervention and Screening in Pharmacy N/A
Completed NCT01934608 - The Effect of Synching Prescription Refills on Adherence N/A
Completed NCT01941836 - Evaluation of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic Patients Phase 2
Recruiting NCT01705873 - Analysis on the Risk of Cardiovascular Events in HIV- Infected Subjects Treated With LPV/r Based HAART Regimen vs. an EFV Based Regimen N/A
Completed NCT01678521 - Effect of LDL-apheresis on PTX3 Plasma Levels in Hypercholesterolemic Patients N/A
Completed NCT01670734 - Pharmacokinetic and Tolerability of Alirocumab SAR236553 (REGN727) in Patients With Hepatic Impairment and in Healthy Subjects Phase 1
Completed NCT01370603 - A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/40 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 40 mg Tablets in Participants With High Cholesterol (MK-0653C-190 AM1) Phase 3
Completed NCT01370590 - A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/20 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 20 mg Tablets in Participants With High Cholesterol (MK-0653C-185 AM1) Phase 3
Completed NCT01575171 - Using Nudges to Implement Comparative Effectiveness N/A
Completed NCT01768403 - Centralised Pan-Algerian Survey on the Undertreatment of Hypercholesterolemia N/A
Completed NCT01478789 - Efficacy of Plant Sterol-Fortified Dairy Product on Plasma Lipid and Plant Sterol Concentrations in Humans N/A