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

Recruiting now · Phase 1

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

In brief

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 facts

Study ID

NCT07491172

Run by

CRISPR Therapeutics AG

People needed

90

Starts

2024-06-21

Expected to finish

2028-06-01

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Participants with familial chylomicronemia syndrome (FCS). Some exceptions may apply.
• Evidence of liver disease, defined as but not limited to:
• LFTS >2 × upper limit of normal (ULN), or total bilirubin >2 × ULN, or INR >1.5 × ULN, or liver stiffness measured by liver elastography
• Abnormal or compromised function of kidney, heart, blood or liver.
• Acute coronary syndrome event or stroke within 24 weeks prior to Day 1. Acute pancreatitis within 12 weeks prior to Day 1.
• Current use or use within 365 days from Day 1 of any hepatocyte-targeted small interfering RNA (except inclisiran).
• Positive serology for HIV, hepatitis B or hepatitis C (antibody, surface antigen orNAT). Serology consistent with prior immunization will be eligible for the trial.
• Any prior malignancy within the past 5 years, or current malignancy (exceptions for resected or removed basal cell carcinoma, squamous cell carcinoma in situ and carcinoma in situ of the cervix or breast).
• Women of childbearing potential.
• Note: Other protocol defined Inclusion/Exclusion criteria may apply.
• Note: The inclusion and exclusion criteria listed represent the global protocol. Additional or modified eligibility criteria may apply in certain countries in accordance with local regulatory and ethics committee requirements and the approved country-specific protocol.

Where it is running

• Austin Health — Heidelberg, Australia (enrolling)
• Monash Medical Center — Melbourne, Australia (enrolling)
• Aotearoa — Auckland, New Zealand (enrolling)
• NZCR — Christchurch, New Zealand (enrolling)
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States (enrolling)
• Flourish Orlando — Orlando, Florida, United States (enrolling)
• United Medical Research — Port Orange, Florida, United States (enrolling)
• Duke Early Phase Clinical Research — Durham, North Carolina, United States (enrolling)
• Peters Medical Research — High Point, North Carolina, United States (enrolling)
• Royal Adelaide — Adelaide, Australia (enrolling)
• Barts — London, United Kingdom (enrolling)
• Richmond Pharmacology — London, United Kingdom (enrolling)
• Integrity Clinical Research — Hialeah, Florida, United States (enrolling)
• Royal Papworth Hospital — Cambridge, United Kingdom
• Oregon Health & Science University (OHSU) — Portland, Oregon, United States
• University of Rochester — Rochester, New York, United States
• Royal Prince Alfred Hospital — Camperdown, Australia
• CORE Research — Brisbane, Australia
• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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