A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of AZD0780 in Participants With Dyslipidaemia

Launched by ASTRAZENECA · Feb 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called AZD0780 to see how well it works and whether it is safe for people with dyslipidaemia, a condition characterized by unhealthy levels of fats in the blood, particularly high LDL cholesterol (often referred to as "bad" cholesterol). The study will last for up to 52 weeks and involves taking the medication by mouth. Participants will be divided into two parts: Part A with about 60 people and Part B with around 320 people. The goal is to find out how effective AZD0780 is and how it is processed in the body.

To be eligible for this trial, participants need to be between 18 and 55 years old in Part A, or at least 18 years old in Part B. They should have specific levels of LDL cholesterol and triglycerides, and generally be in good health. For example, participants should not have been taking cholesterol-lowering medications for at least eight weeks, and they should not have any serious health issues like recent heart problems or cancer (with some exceptions). Those who join the study can expect regular check-ins and tests to monitor their health throughout the trial. This study is currently recruiting participants, and it’s a great opportunity for those looking for new treatment options for their condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • PART A
• • 1. Males, and females of non-childbearing potential, 18 to 55 years of age, at the time of signing the informed consent.
• • 2. Diagnosis of dyslipidaemia: and with fasting LDL-C ≥ 100 mg/dL (2.6 mmol/L) and \< 190 mg/dL (4.9 mmol/L) at screening (Visit 1).
• • 3. Fasting triglycerides \< 400 mg/dL (\< 4.52 mmol/L) at screening (Visit 1).
• • 4. Not on any LLTs for ≥ 8 weeks prior to screening (Visit 1), except for a heart-healthy lifestyle.
• • 5. No planned LLTs using during study participation.
• • 6. Body mass index ≥ 18 and ≤35 kg/m\^2 , weigh ≥50 kg and ≤120 kg.
• • PART B
• • 1. Males, and females, ≥ 18 years of age, at the time of signing the informed consent.
• • 2. Meets one of the ASCVD status/risk categories and has a corresponding fasted LDL-C value at screening (Visit 1) .
• • (1) LDL ≥ 55 mg/dl if ASCVD present OR LDL ≥ 100 mg/dl if there is no history of clinical ASCVD.
• • (2) Subject without clinical ASCVD are eligible if they have either, ASCVD risk equivalents \[diabetes mellitus,LDL-C ≥ 4.9 mmol/L or TC ≥ 7.2 mmol/L, HeFH, CKD (stage 3-5)\]. OR a 10 year moderate to high risk for ASCVD.
• • 3. Fasting triglycerides \< 400 mg/dL (\< 4.52 mmol/L). 4. Background LLTs: For Cohort 1: on a stable dose of LLTs including medications and supplements ≥ 28 days before screening (Visit 1).
• For Cohort 2: Meet one of the following before screening (Visit 1):
• • 1. On a stable dose of LLTs.
• • 2. On a stable dose of LLTs without any statins.
• • 3. Not received treatment with any LLTs.
• Exclusion Criteria:
• • PART A
• • 1. Malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in-situ, or Stage 1 prostate carcinoma) within the last 10 years.
• • 2. Recipient of any major organ transplant, eg, lung, liver, heart, bone marrow, renal.
• • 3. Homozygous familial hypercholesterolaemia, Know diagnosis of HeFH, LDL apheresis or plasma apheresis within 12 months prior to screening (Visit 1).
• • 4. QTcF \> 450 ms; high degree atrioventricular-block grade II-III and sinus node dysfunction with significant sinus pause untreated with pacemaker; and cardiac tachyarrhythmias.
• • 5. A LDL-C reduction that is \< 30% post rosuvastatin run-in period (Day -8).
• • PART B
• • 1. Acute ischaemic cardiovascular event within 7 days prior to screening (Visit 1).
• • 2. Coronary revascularisation procedure planned within 6 months after the screening procedures (Visit 1).
• • 3. eGFR \< 45 mL/min/1.73m2 using the CKD-EPI 2021 (age, sex) equation at screening (Visit 1).
• • 4. Poorly controlled type 2 diabetes mellitus, defined as HbA1c \> 10% at screening (Visit 1).
• • 5. Heart failure with New York Heart Association Class IV.
• • 6. Malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in-situ, or Stage 1 prostate carcinoma) within 5 years prior to screening (Visit 1).
• • 7. Severe concomitant non-CVD with risk of life expectancy \< 2 years.
• • 8. Recipient of any major organ transplant, eg, lung, liver, heart, bone marrow, renal.
• • 9. 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.
• • 10. Uncontrolled hypertension defined as average sitting SBP \> 160 mmHg or DBP \> 90 mmHg at screening (Visit 1).
• • 11. Participants with one or more of these findings (shortened QTcF \< 340 ms; family history of long QT syndrome; PR interval shortening \< 120 ms; PR interval prolongation \>220 ms; persistent or intermittent complete bundle branch block, incomplete bundle branch, or interventricular conduction delay with QRS \> 110 ms) should be excluded only if they are judged to be clinically important by the Investigator.
• • 12. QTcF \> 450 ms; high degree atrioventricular-block grade II-III and sinus node dysfunction with significant sinus pause untreated with pacemaker; and cardiac tachyarrhythmias.