RECRUITING

A Phase III Study to Assess the Effect of AZD0780 on LDL-C in Patients With HeFH

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Conditions

Heterozygous Familial HypercholesterolaemiaLow-Density Lipoprotein Cholesterol

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a study to evaluate the efficacy and safety of AZD0780 in adults with HeFH and elevated LDL-C, either with clinical ASCVD and LDL-C levels of 55 mg/dL or higher or without clinical ASCVD and LDL-C levels of 70 mg/dL or higher. AZD0780 is a small molecule that reduces the amount of LDL-C in the blood. Placebo will be used for comparison, and neither the participants nor the Investigators will know who is receiving the AZD0780 medication and who is receiving the placebo until the end of study. The total length of the study for an individual participant will be up to approximately 56 weeks, including a screening period of up to 14 days, treatment with AZD0780 or placebo for 52 weeks, and a safety follow-up period of 10 days.

Official Title

A Phase III, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Effect of AZD0780 on Low-Density Lipoprotein Cholesterol in Patients With Heterozygous Familial Hypercholesterolaemia

Quick Facts

Study Start:2025-06-10
Study Completion:2027-04-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07000136

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥ 18 years of age at the time of signing the ICF.
  2. * Diagnosis of HeFH by genetic confirmation or a definite clinical diagnosis, ie, a score \> x using the Dutch Lipid Network \[Nordestgaard et al 2013\] or equivalent as per internationally accepted diagnostic algorithms (AHA \[Gidding et al 2015\], US MEDPED \[Williams et al 1993\], Simon Broome \[Scientific Steering Committee on behalf of the Simon Broome Register Group 1991\], or Japanese Atherosclerosis Society Guidelines \[Okamura et al 2024\])
  3. * Fasting serum by central laboratory at screening as follows: LDL-C ≥ 55 mg/dL (≥ 1.4 mmol/L) in participants with HeFH and clinical ASCVD or ≥ 70 mg/dL (≥ 1.8 mmol/L) in HeFH without clinical ASCVD. Clinical ASCVD is defined as MI, stable or unstable angina, coronary or other arterial revascularisation, ischaemic stroke, or peripheral artery disease.
  4. * Participants should be receiving a maximally tolerated lipid lowering regimen including a maximally tolerated statin. Ezetimibe is further strongly recommended.
  5. 1. Participants must achieve a stable dose (\> 28 days) of lipid lowering therapies before screening.
  6. 2. Participants who are judged by the treating physician not to tolerate high intensity statins (according to guidelines, typically, atorvastatin ≥ 40 mg once daily or rosuvastatin ≥ 20 mg once daily) may be included if treated with a low- or moderate intensity statin dose.
  7. 3. Participants not receiving any statins must have documented intolerable side effects to at least 2 different statins, including one at the lowest standard dose or on a chronic medication that would prohibit the use of a statin (according to the prescribing information for the statin in question).
  1. * Homozygous familial hypercholesterolaemia, LDL apheresis or plasma apheresis within 12 months prior to screening, or any other underlying known disease or condition that may interfere with interpretation of the clinical study results as judged by the Investigator.
  2. * Any of the following laboratory values at screening:
  3. * Calculated eGFR \< 15 mL/min/1.73 m2
  4. * AST or ALT \> 3 × ULN
  5. * TBL \> 2 × ULN (except for patients with Gilberts syndrome, where TBL 3 × ULN is acceptable provided direct bilirubin \< 1.5 × ULN)
  6. * Fasting triglycerides ≥ 400 mg/dL (≥ 4.52 mmol/L)
  7. * Creatine kinase \> 5 × ULN
  8. * Urine albumin-to-creatinine ratio ≥ 500 mg/g
  9. * Uncontrolled type 2 diabetes mellitus defined as HbA1C ≥ 9.5% at screening
  10. * Inadequately treated hypothyroidism defined as TSH \> 1.5 ULN at screening or participants whose thyroid replacement therapy was initiated or modified within the last 3 months prior to screening
  11. * Use of mipomersen or lomitapide (cholesterol-lowering medications) within 12 months prior to screening or planned use during the study.
  12. * Use of gemfibrozil within 1 week prior to screening or planned use during the study.
  13. * Use of PCSK-9 inhibitors: evolocumab/alirocumab within 12 weeks of the screening visit or planned use during the study or inclisiran within 18 months of the screening visit or planned use during the study. Any other approved PCSK-9 inhibitor use within 5 half lives prior to the screening visit or planned use during the study.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Study Locations (Sites)

Research Site
Chula Vista, California, 91911
United States
Research Site
Garden Grove, California, 92844
United States
Research Site
Lake Forest, California, 92630
United States
Research Site
Norco, California, 92860
United States
Research Site
San Diego, California, 92111
United States
Research Site
Hialeah, Florida, 33012
United States
Research Site
Orlando, Florida, 32807
United States
Research Site
Peachtree Corners, Georgia, 30092
United States
Research Site
Chicago, Illinois, 60607
United States
Research Site
Carmel, Indiana, 46290
United States
Research Site
Eunice, Louisiana, 70535
United States
Research Site
Hammond, Louisiana, 70403
United States
Research Site
Duluth, Minnesota, 55805
United States
Research Site
Las Vegas, Nevada, 89119
United States
Research Site
Durham, North Carolina, 27701
United States
Research Site
Morganton, North Carolina, 28655
United States
Research Site
Cincinnati, Ohio, 45227
United States
Research Site
Lima, Ohio, 45805
United States
Research Site
Rapid City, South Dakota, 57701
United States
Research Site
Chattanooga, Tennessee, 37404
United States
Research Site
Houston, Texas, 77043
United States
Research Site
Humble, Texas, 77338
United States
Research Site
Kingwood, Texas, 77345
United States
Research Site
McAllen, Texas, 78503
United States
Research Site
Mesquite, Texas, 75149
United States
Research Site
Redmond, Washington, 98052
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-10
Study Completion Date2027-04-06

Study Record Updates

Study Start Date2025-06-10
Study Completion Date2027-04-06

Terms related to this study

Keywords Provided by Researchers

  • Low-Density Lipoprotein Cholesterol

Additional Relevant MeSH Terms

  • Heterozygous Familial Hypercholesterolaemia