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

Part of paid clinical trials in Hialeah, 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

First listed
Mar 24, 2026
Start date
Jun 21, 2024
Status verified
Jul 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 (9)

FacilityCityStateZIPSite coordinators
Integrity Clinical ResearchHialeahFlorida33015-
Jacksonville Center for Clinical ResearchJacksonvilleFlorida32216-
Flourish OrlandoOrlandoFlorida32789-
United Medical ResearchPort OrangeFlorida32127-
University of RochesterRochesterNew York14642-
Duke Early Phase Clinical ResearchDurhamNorth Carolina27710-
Peters Medical ResearchHigh PointNorth Carolina27260-
Cleveland ClinicClevelandOhio44195-
Oregon Health & Science University (OHSU)PortlandOregon97239-

Find similar trials in Hialeah, FL

By research site
Integrity Clinical Research· Hialeah, FLJacksonville Center for Clinical Research· Jacksonville, FLFlourish Orlando· Orlando, FLUnited Medical Research· Port Orange, FLUniversity of Rochester· Rochester, NYDuke Early Phase Clinical Research· Durham, NC

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