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ZODASIRAN

ZODASIRAN is being studied in clinical trials for people with homozygous familial hypercholesterolemia, a rare condition that causes very high LDL cholesterol. These trials are designed to evaluate how well it lowers LDL cholesterol and to compare it with placebo in adolescent and adult participants.

Table of Contents

Trial overview

The provided trial information describes one Phase 3 study of ZODASIRAN called YOSEMITE.[1] It is an interventional study, which means researchers give a study treatment and then measure the results.[1]

This study is focused on people with homozygous familial hypercholesterolemia (HoFH), a rare inherited condition that causes very high LDL cholesterol.[1] The brief study summary says the goal is to show a reduction in LDL cholesterol with ZODASIRAN compared with placebo.[1]

Who can participate

The study is for adolescent and adult subjects with HoFH.[1] The source data do not give the full list of entry rules, so the exact age limits and other requirements are not provided here.[1]

Because the trial is for HoFH, it is aimed at people who already have this specific condition rather than the general population.[1]

What is being measured

The main endpoint is the percent change from baseline to Month 12 in fasting LDL-C during the randomized period.[1] An endpoint is the main result researchers use to judge whether a trial is working.[1]

Baseline means the starting point before treatment begins, and fasting LDL-C means LDL cholesterol measured after not eating for a period of time.[1] The study is set up to see whether ZODASIRAN lowers this value more than placebo over 12 months.[1]

Trial design and treatment groups

The trial compares ZODASIRAN with a placebo, which is a look-alike treatment with no active study drug.[1] The treatment listed in the source is “Drug: Placebo of ZODASIRAN,” showing that participants are compared against a placebo group.[1]

The intervention listed for the active study treatment is “ARO-ANG3 (200 mg milligram(s), SUBCUTANEOUS INJECTION),” but the trial title and summary identify the study as a ZODASIRAN trial.[1] The source data do not provide more details about how the treatment is given beyond the injection route shown in the intervention list.[1]

Study status and size

The trial status is listed as Authorised, meaning the study has been approved to proceed in the source record.[1] The planned enrollment is 61 participants.[1]

This is a relatively small study population, which is common in trials for rare diseases like HoFH.[1] The available data do not include final results, so the trial record here describes the study plan rather than the outcome.[1]

Trial ID Phase Condition studied Status Enrollment
NCT07037771 Phase 3 Homozygous familial hypercholesterolemia (HoFH) Authorised 61

FAQ

  • What condition is being studied in ZODASIRAN trials? The trial data provided focus on homozygous familial hypercholesterolemia, also called HoFH. This is a rare inherited condition that leads to very high LDL cholesterol.
  • Who can take part in the ZODASIRAN study? The study is for adolescent and adult subjects with HoFH. Other exact entry rules are not provided in the trial data.
  • What phase is the ZODASIRAN trial? The trial listed is a Phase 3 study. Phase 3 trials usually compare a study treatment with another treatment or placebo in a larger group of people.
  • What is the main goal of the trial? The main goal is to see whether ZODASIRAN reduces fasting LDL cholesterol better than placebo. The trial measures the percent change from the start of the study to Month 12.
  • How many people are planned for the study? The trial plans to enroll 61 participants. This gives researchers a group large enough to compare results between study treatment and placebo.

Ongoing Clinical Trials on ZODASIRAN

  • A study testing how well zodasiran works and how safe it is for teenagers and adults with homozygous familial hypercholesterolemia

    Recruiting

    1 1
    Investigated drugs:
    Austria Belgium Czechia France Germany Greece +4

Glossary

  • Homozygous familial hypercholesterolemia (HoFH): A rare inherited condition that causes very high LDL cholesterol from a young age.
  • LDL cholesterol (LDL-C): Often called 'bad cholesterol,' this is a type of fat in the blood that can build up in blood vessels.
  • Fasting LDL-C: LDL cholesterol measured after not eating for a period of time, so the result is more accurate.
  • Placebo: A look-alike treatment with no active study drug, used for comparison in a trial.
  • Phase 3: A later stage of clinical research that tests how well a treatment works and continues to monitor safety.
  • Adolescent: A young person who is older than a child but not yet an adult.
  • Adult: A fully grown person who is eligible by age for the study.
  • Interventional study: A study in which researchers assign a treatment or placebo and then measure the results.
  • Randomized period: A study phase where participants are assigned by chance to different study groups.
  • Percent change from baseline: The amount of change compared with the starting value, shown as a percentage.

References