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Evaluating AZD0780 for treating high cholesterol levels

A Randomised, Double-blind, Placebo-controlled, Multi-centre, Sequential Phase II, and Phase III Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of AZD0780 Administered for up to 52 Weeks in Participants With Dyslipidaemia

Phase2; Phase3 Interventional AstraZeneca · NCT06834932

This study is testing a new medication called AZD0780 to see if it can help people with high cholesterol lower their bad cholesterol levels while they are also taking other cholesterol-lowering treatments.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment300 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Locations24 sites (Baotou and 23 other locations)
Trial IDNCT06834932 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized, double-blind, placebo-controlled study designed to assess the efficacy, safety, and pharmacokinetics of AZD0780 in participants with dyslipidaemia. It consists of two parts: Part A, a Phase II study focusing on pharmacokinetics and tolerability with about 60 participants, and Part B, a Phase III study involving approximately 320 participants to evaluate the reduction of LDL-C levels while on background lipid-lowering therapy. Participants will receive either AZD0780, placebo, or different doses of Rosuvastatin over a period of up to 52 weeks.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 55 with dyslipidaemia and specific LDL-C levels, as well as those on stable lipid-lowering therapy.

Not a fit: Patients with severe dyslipidaemia or those who are not eligible for lipid-lowering therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with elevated LDL cholesterol levels.

How similar studies have performed: Other studies have shown promise in using similar approaches for managing dyslipidaemia, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Baotou and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions DyslipidaemiaAZD0780
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.