A Safety and Tolerability Trial Evaluating CTX310 in Participants With Refractory Dyslipidemias (NCT07491172) | Clinical Trial Compass
RecruitingPhase 1
A Safety and Tolerability Trial Evaluating CTX310 in Participants With Refractory Dyslipidemias
United States90 participantsStarted 2024-06-21
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age of ≥18 and ≤75 years at the time of signing the informed consent.
✓. Able to provide written informed consent.
✓. Participants diagnosed with persistent dyslipidemias defined by TG ≥150 mg/dL - and LDL-C ≥70 mg/dL in participants with ASCVD, or LDL-C ≥70 or 100mg/dL in participants with or without ASCVD respectively, or TG ≥500 mg/dL.
✓. Refractory to the maximal intensity or MTD of standard of care lines of lipid-lowering therapies available through routine clinical care, for at least 12 weeks prior to screening
✓. Female participants must be postmenopausal or surgically sterile.
✓. All male participants and their female partners must agree to the use of an acceptable method of effective contraception for the duration of the study.
Exclusion criteria
✕. Participants with familial chylomicronemia syndrome (FCS). Some exceptions may apply.
✕. Evidence of liver disease, defined as but not limited to:
✕. 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).
What they're measuring
1
To evaluate the safety of CTX310 in adult subjects with dyslipidemias that are refractory to available treatments
. 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).