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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06451770




Registration number
NCT06451770
Ethics application status
Date submitted
4/06/2024
Date registered
11/06/2024
Date last updated
8/05/2025

Titles & IDs
Public title
Phase 1b Study of VERVE-201 in Patients With Refractory Hyperlipidemia
Scientific title
A Phase 1b Single Ascending Dose Study to Evaluate the Safety of VERVE-201 in Patients With Refractory Hyperlipidemia
Secondary ID [1] 0 0
VT-20101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypercholesterolemia 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - VERVE-201

Experimental: Cohort 1: Single Ascending Dose Escalation - Participants will receive a single dose of VERVE-201.

Experimental: Cohort 2: Single Ascending Dose Escalation - Participants will receive a single dose of VERVE-201.

Experimental: Cohort 3: Single Ascending Dose Escalation - Participants will receive a single dose of VERVE-201.

Experimental: Cohort 4: Single Ascending Dose Escalation - Participants will receive a single dose of VERVE-201.


Treatment: Drugs: VERVE-201
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 serum ANGPTL3 concentration
Timepoint [4] 0 0
Up to Day 365
Secondary outcome [5] 0 0
Percent and absolute change from baseline in serum LDL-C
Timepoint [5] 0 0
Up to Day 365

Eligibility
Key inclusion criteria
* Refractory hypercholesterolemia
* 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
* 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
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
30/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2027
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Clinical Study Center - Melbourne
Recruitment postcode(s) [1] 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
Toronto
Country [3] 0 0
United Kingdom
State/province [3] 0 0
London

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
[email protected]
Contact person for scientific queries

Data sharing statement


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/NCT06451770