Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT07491172

A Safety and Tolerability Trial Evaluating CTX310 in Participants With Refractory Dyslipidemias

Led by CRISPR Therapeutics AG · Updated on 2026-03-24

90

Participants Needed

18

Research Sites

205 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a single-arm, open-label, multicenter, ascending dose Phase 1 trial that will enroll participants 18 to 75 years of age with dyslipidemias that are refractory to available treatments.

CONDITIONS

Official Title

A Safety and Tolerability Trial Evaluating CTX310 in Participants With Refractory Dyslipidemias

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years at the time of signing informed consent
  • Able to provide written informed consent
  • Diagnosed with persistent dyslipidemias defined by specific triglyceride and LDL cholesterol levels according to ASCVD status
  • Dyslipidemia refractory to maximal or maximum tolerated lipid-lowering therapies for at least 12 weeks prior to screening
  • Female participants must be postmenopausal or surgically sterile
  • Male participants and female partners must agree to use effective contraception during the study
Not Eligible

You will not qualify if you...

  • Diagnosis of familial chylomicronemia syndrome (FCS), with some exceptions
  • Evidence of liver disease including elevated liver function tests, high bilirubin, abnormal INR, or liver stiffness
  • Abnormal or impaired kidney, heart, blood, or liver function
  • Acute coronary syndrome or stroke within 24 weeks prior to Day 1; acute pancreatitis within 12 weeks prior to Day 1
  • Use of hepatocyte-targeted small interfering RNA treatments within 365 days prior to Day 1 (except inclisiran)
  • Positive tests for HIV, hepatitis B, or hepatitis C (except prior immunization)
  • Any malignancy within the past 5 years or current malignancy (except certain skin and cervical/breast cancers)
  • Women of childbearing potential

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 18 locations

1

Research Site 10

Jacksonville, Florida, United States, 32216

Not Yet Recruiting

2

Research Site 17

Orlando, Florida, United States, 32789

Not Yet Recruiting

3

Research Site 11

Port Orange, Florida, United States, 32127

Not Yet Recruiting

4

Research Site 14

Durham, North Carolina, United States, 27710

Not Yet Recruiting

5

Research Site 13

High Point, North Carolina, United States, 27260

Not Yet Recruiting

6

Research Site 9

Cleveland, Ohio, United States, 44195

Not Yet Recruiting

7

Research Site 12

Portland, Oregon, United States, 97239

Not Yet Recruiting

8

Research Site 1

Adelaide, Australia, 5000

Actively Recruiting

9

Research Site 15

Brisbane, Australia, 4064

Not Yet Recruiting

10

Research Site 16

Brisbane, Australia

Not Yet Recruiting

11

Research Site 7

Camperdown, Australia, 2050

Not Yet Recruiting

12

Research Site 3

Heidelberg, Australia, 3084

Actively Recruiting

13

Research Site 2

Melbourne, Australia, 3168

Actively Recruiting

14

Research Site 5

Auckland, New Zealand, 2025

Actively Recruiting

15

Research Site 4

Christchurch, New Zealand, 8011

Actively Recruiting

16

Research Site 18

Cambridge, United Kingdom

Not Yet Recruiting

17

Research Site 8

London, United Kingdom, E1 1BB

Not Yet Recruiting

18

Research Site 6

London, United Kingdom, SE1 1YR

Actively Recruiting

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Research Team

C

Clinical Trials

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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