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

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
CRISPR Therapeutics AG
Study ID
NCT07491172
Phase
PHASE1
Status
Recruiting
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Conditions

  • Cardiovascular
  • Dyslipidemias
  • Heterozygous Familial Hypercholesterolemia (HeFH)
  • Homozygous Familial Hypercholesterolemia (HoFH)
  • Hypercholesterolaemia
  • Hypertriglyceridemia
  • Lipid Disorder
  • Metabolic Disease
  • Mixed Hyperlipemia
  • Severe Hypertriglyceridemia (sHTG)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • CTX310 — DRUG
    CTX310 is a lipid nanoparticle (LNP) formulation of clustered regularly interspaced short palindromic repeats (CRISPR)-associated protein 9 (Cas9) components for in vivo editing of the target gene angiopoietin-like 3 (ANGPTL3).

Study Details

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.

Key Dates

Start date
Jun 21, 2024
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
90 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CTX310
    Subjects will receive an intravenous (IV) infusion.

Primary Outcome Measure

To evaluate the safety of CTX310 in adult subjects with dyslipidemias that are refractory to available treatments [ Time Frame: From CTX310 infusion up to 12 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Research Site 10JacksonvilleFlorida32216-
Research Site 17OrlandoFlorida32789-
Research Site 11Port OrangeFlorida32127-
Research Site 14DurhamNorth Carolina27710-
Research Site 13High PointNorth Carolina27260-
Research Site 9ClevelandOhio44195-
Research Site 12PortlandOregon97239-

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