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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06164730




Registration number
NCT06164730
Ethics application status
Date submitted
1/12/2023
Date registered
11/12/2023
Date last updated
12/11/2024

Titles & IDs
Public title
A Study of VERVE-102 in Patients with Familial Hypercholesterolemia or Premature Coronary Artery Disease
Scientific 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
Secondary ID [1] 0 0
VT-10201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heterozygous Familial Hypercholesterolemia 0 0
Premature Coronary Heart Disease 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Complications of newborn
Reproductive Health and Childbirth 0 0 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - VERVE-102

Experimental: Cohort 1: Single Ascending Dose Escalation - Participants will receive a single dose of VERVE-102.

Experimental: Cohort 2: Single Ascending Dose Escalation - Participants will receive a single dose of VERVE-102.

Experimental: Cohort 3: Single Ascending Dose Escalation - Participants will receive a single dose of VERVE-102.

Experimental: Cohort 4: Single Ascending Dose Escalation - Participants will receive a single dose of VERVE-102.


Treatment: Drugs: VERVE-102
Intravenous (IV) infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Timepoint [1] 0 0
up to Day 365
Secondary outcome [1] 0 0
Evaluation of maximum observed concentration (Cmax)
Timepoint [1] 0 0
up to Day 365
Secondary outcome [2] 0 0
Evaluation of time to maximum observed concentration (tmax)
Timepoint [2] 0 0
up to Day 365
Secondary outcome [3] 0 0
Evaluation of terminal elimination half-life (t1/2)
Timepoint [3] 0 0
up to Day 365
Secondary outcome [4] 0 0
Percent and absolute change from baseline in plasma PCSK9 concentration
Timepoint [4] 0 0
up to Day 365
Secondary outcome [5] 0 0
Percent and absolute change from baseline in LDL-C
Timepoint [5] 0 0
up to Day 365

Eligibility
Key inclusion criteria
* Diagnosis of HeFH or premature CAD
* Females of non-childbearing potential or males
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Homozygous familial hypercholesterolemia
* Active or history of chronic liver disease
* Current treatment with PCSK9 inhibitor or prior treatment within specified timeframe
* Clinically significant or abnormal laboratory values as defined by the protocol

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2026
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Clinical Study Center - Adelaide
Recruitment hospital [2] 0 0
Clinical Study Center - Melbourne
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Chicoutimi
Country [2] 0 0
Canada
State/province [2] 0 0
Montreal
Country [3] 0 0
Canada
State/province [3] 0 0
Toronto
Country [4] 0 0
New Zealand
State/province [4] 0 0
Christchurch
Country [5] 0 0
United Kingdom
State/province [5] 0 0
London
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Verve Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Development
Address 0 0
Country 0 0
Phone 0 0
781-970-6833
Fax 0 0
Email 0 0
verve102clinicaltrials@vervetx.com
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06164730