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DyslipidaemiaPhase 2/3NCT06834932

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

A Phase 2/3 study testing Rosuvastatin Dose 1, Rosuvastatin dose 2 and AZD0780 in people with Dyslipidaemia, run by AstraZeneca at 42 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a randomised, double-blind, placebo-controlled, multi-centre, sequential Phase II and Phase III study that will evaluate the efficacy, safety, and PK of AZD0780 administered orally for up to 52 weeks in participants with elevated LDL-C. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dyslipidaemia
What is being tested?
Rosuvastatin Dose 1, Rosuvastatin dose 2 and AZD0780
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
432 participants
Where
42 sitesin 2 countries
Study dates
6 Dec 2024to 22 Feb 2027
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • PART A
  • Males, and females of non-childbearing potential, 18 to 55 years of age, at the time of signing the informed consent.
  • 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).
  • Fasting triglycerides < 400 mg/dL (< 4.52 mmol/L) at screening (Visit 1).
  • Not on any LLTs for ≥ 8 weeks prior to screening (Visit 1), except for a heart-healthy lifestyle.
  • No planned LLTs using during study participation.
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  • Body mass index ≥ 18 and ≤35 kg/m^2 , weigh ≥50 kg and ≤120 kg.
  • PART B
  • Males, and females, ≥ 18 years of age, at the time of signing the informed consent.
  • Meets one of the ASCVD status/risk categories and has a corresponding fasted LDL-C value at screening (Visit 1) .
  • Participants with clinical ASCVD, LDL-C ≥ 55 mg/dl (ultra-high risk) and ≥ 70 mg/dl (very high risk).
  • Participants without clinical ASCVD, at moderate to high risk for ASCVD at 10 years, LDL-C ≥ 100 mg/dl. ASCVD risk equivalents [diabetes mellitus,LDL-C ≥ 4.9 mmol/L or TC ≥ 7.2 mmol/L, HeFH, CKD (stage 3-5)] are also eligible.
  • 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). , that typically include moderate to high-intensity statins for ≥ 28 days before screening (LLTs include medications [eg, statins, ezetimibe, niacin] and supplements [eg, omega-3 fatty acids] that can affect cholesterol levels).
  • Participants intolerant to moderate or high intensity statins per the 2023 Chinese Guideline may be included if treated with a low intensity statin.
  • Participants not on statins must have documented intolerance to at least two statins (including one at the lowest standard dose) or be on chronic medication contraindicating statin use.
  • For Cohort 2: Meet one of the following before screening (Visit 1):
  • On a stable dose of LLTs including moderate statins .
  • On a stable dose of LLTs without any statins.
  • Not received treatment with any LLTs.

Who cannot join

  • PART A
  • 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.
  • Recipient of any major organ transplant, eg, lung, liver, heart, bone marrow, renal.
  • Homozygous familial hypercholesterolaemia, Know diagnosis of HeFH, LDL apheresis or plasma apheresis within 12 months prior to screening (Visit 1).
  • QTcF > 450 ms; high degree atrioventricular-block grade II-III and sinus node dysfunction with significant sinus pause untreated with pacemaker; and cardiac tachyarrhythmias.
  • A LDL-C reduction that is < 30% post rosuvastatin run-in period (Day -8).
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  • PART B
  • Acute ischaemic ASCVD event within 7 days prior to screening (Visit 1).
  • Any uncontrolled or serious disease.
  • eGFR < 15 mL/min/1.73m2 using the CKD-EPI 2021 (age, sex) equation at screening (Visit 1).
  • Uncontrolled type 2 diabetes mellitus, defined as HbA1c ≥ 9.5% at screening (Visit 1).
  • Heart failure with New York Heart Association Class IV.
  • Malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma) within 5 years prior to screening (Visit 1).
  • Severe concomitant non-CVD with risk of life expectancy < 2 years.
  • Recipient of any major organ transplant, eg, lung, liver, heart, bone marrow, renal.
  • 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.
  • Uncontrolled hypertension defined as average sitting SBP > 160 mmHg or DBP > 110 mmHg at screening (Visit 1) or randomization despite antihypertensive therapy (based on the mean of the 3 consecutive readings).
  • Any laboratory values with the following deviations at screening (Visit 1)
  • Any positive result on screening for hepatitis B or hepatitis C.
  • ALT > 3 × ULN.
  • AST > 3 × ULN.
  • TBL > 2 × ULN (except for participants with Gilberts syndrome, where TBL 3 × ULN is acceptable provided direct bilirubin < 1.5 × ULN)
  • Creatine kinase > 5 × ULN
  • Urine albumin-to-creatinine ratio ≥ 500 mg/g
  • QTcF > 470 ms; high degree atrioventricular-block grade II-III and sinus node dysfunction with significant sinus pause untreated with pacemaker; and cardiac tachyarrhythmias.
  • Current administration of PCSK9 inhibitor, siRNA or mAb (approved or investigational) at screening.
  • Mipomersen or microsomal triglyceride transfer protein inhibitor (eg, lomitapide) use within 12 months prior to screening or planned ues during the study.
  • Use of PCSK-9 inhibitors: evolocumab/alirocumab within 12 weeks, inclisiran within 18 months, tafolecimab, ebronucimab, ongericimab, and recaticimab within 3 to 6 months before screening or planned use during the study; or any other PCSK-9 inhibitor within 5 half-lives before screening or planned use during the study.
  • Use of any lipid-lowing traditional Chinese medicine (expect Xuezhikang) within 8 weeks before screening.
  • Use of gemfibrozil within one week before screening or planned use during the study.
  • Receiving, or has received within 14 days of screening, medication with a black box warning for significant QT prolongation.

Trial locations and contacts

42 sites in 2 countries.

42 sites in 2 countries

China40 sites

  • Research Site

    Baotou, 14010

  • Research Site

    Beijing, 100029

  • Research Site

    Beijing, 100050

  • Research Site

    Bengbu, 233004

  • Research Site

    Changchun, 130021

  • Research Site

    Changchun, 130033

  • Research Site

    Changde, 415000

  • Research Site

    Changsha, 410015

  • Research Site

    Changzhou, 272100

  • Research Site

    Chengdu, 610000

  • Research Site

    Chongqing, 402260

  • Research Site

    Daqing, 163000

  • Research Site

    Deyang, 618000

  • Research Site

    Guangzhou, 510100

  • Research Site

    Guangzhou, 510220

  • Research Site

    Hengyang, 421001

  • Research Site

    Heze, 274099

  • Research Site

    Linhai, 317000

  • Research Site

    Luoyang, 471000

  • Research Site

    Nanchang, 330009

  • Research Site

    Nanchong, 637900

  • Research Site

    Nanjing, 210009

  • Research Site

    Pingxiang, 337055

  • Research Site

    Qiqihar, 161000

  • Research Site

    Sanya, 572000

  • Research Site

    Shanghai, 200032

  • Research Site

    Shanghai, 200120

  • Research Site

    Shanghai, 310000

  • Research Site

    Shenyang, 110004

  • Research Site

    Shenyang, 110016

  • Research Site

    Siping, 136000

  • Research Site

    Taiyuan, 030024

  • Research Site

    Tianjin, 300457

  • Research Site

    Wuhan, 430010

  • Research Site

    Wuhan, 430030

  • Research Site

    Wuhan, 430060

  • Research Site

    Xi'an, 710068

  • Research Site

    Xianyang, 750004

  • Research Site

    Yinchuan, 750004

  • Research Site

    Zigong, 643021

Other trials in China

Hong Kong2 sites

  • Research Site

    Hong Kong, 999077

  • Research Site

    Shatin, 00000

Other trials in Hong Kong

About this study

Official title: 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 (AZURE-CHINA)

This is a randomised, double-blind, placebo-controlled, multi-centre, sequential Phase II and Phase III study that will evaluate the efficacy, safety, and PK of AZD0780 administered orally for up to 52 weeks in participants with elevated LDL-C. The study consist of 2 separate parts (Part A and Part B) approximately 60 participants will be randomised in Part A. There will be 2 cohorts in Part B (approximately 220 participants in Cohort 1 and 100 participants in Cohort 2).

Read the detailed description

The planned study includes 2 parts. Part A will be the Phase II study and aims to evaluate the PK, PD, safety, and tolerability of AZD0780. Part B will be the Phase III study and aims to evaluate the reduction of LDL-C as well as the safety and tolerability after oral administration of AZD0780 on background lipid-lowing therapy including moderate to high-intensity statins.

For Part A, approximately 60 participants who meet the eligibility criteria will be randomised. Part A will comprise 4 periods totalling up to 80 days.

For Part B, approximately 220 participants who meet the eligibility criteria will be randomised in Cohort 1, and approximately 100 participants who meet the eligibility criteria will be randomised in Cohort 2.

Cohort 1: participants are on a stable dose of LLTs, including moderate to high-intensity statins for≥ 28 days before screening.

Cohort 2: participants could be with moderate-intensity or without statins therapy (not due to statin intolerance) in background LLTs or not on any LLTs .

Conditions
Dyslipidaemia
Being tested
Placebo, Rosuvastatin Dose 1, Rosuvastatin dose 2, AZD0780
Keywords
AZD0780, Dyslipidaemia
Medical subject headings
Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Administered orally as tablets

  • Rosuvastatin Dose 1Drug

    Administered orally as tablets

  • Rosuvastatin dose 2Drug

    Administered orally as tablets

  • AZD0780Drug

    Administered orally as tablets

Study groups in NCT06834932
Study groupRoleWhat they receive
AZD0780 +Rosuvastatin Dose 1 (Part A)Experimental* Participants will receive Rosuvastatin Dose 1 QD for minimum 21 days (up to 28 days) * Then receive AZD0780 QD as add on for next 28 days (Part A)
Receives: Drug: Rosuvastatin Dose 1; Drug: AZD0780
Placebo +Rosuvastatin Dose 1 (Part A)Placebo comparator* Participants will receive Rosuvastatin Dose 1 QD for minimum 21 days (up to 28 days) * Then receive Placebo QD as add on for next 28 days (Part A)
Receives: Drug: Placebo; Drug: Rosuvastatin Dose 1
AZD0780 +Rosuvastatin Dose 2 (Part A)Experimental* Participants will receive Rosuvastatin Dose 2 QD for minimum 21 days (up to 28 days) * Then receive AZD0780 QD as add on for next for 28 days (Part A)
Receives: Drug: Rosuvastatin dose 2; Drug: AZD0780
Placebo + Rosuvastatin Dose 2 (Part A)Placebo comparator* Participants will receive Rosuvastatin Dose 2 QD for minimum 21 days (up to 28 days) * Then receive Placebo QD as add on for 28 days (Part A)
Receives: Drug: Placebo; Drug: Rosuvastatin dose 2
AZD0780 (Part B Cohort 1)Experimental• Participate will receive AZD0780 QD for 52 weeks (Part B Cohort 1)
Receives: Drug: AZD0780
Placebo (Part B Cohort 1)Placebo comparator• Participate will receive Placebo QD for 52 weeks (Part B Cohort 1)
Receives: Drug: Placebo
AZD0780+Rosuvastatin Dose 1 (Part B Cohort 2)Experimental* Participate receive Rosuvastatin Dose 1 for 28 days. * Then receive AZD0780 QD as add on for 12 weeks (Part B Cohort 2)
Receives: Drug: Rosuvastatin Dose 1; Drug: AZD0780
Placebo+Rosuvastation Dose 1 (Part B Cohort 2)Placebo comparator* Participate receive Rosuvastatin Dose 1 for 28 days. * Then receive Placebo QD as add on for 12 weeks (Part B Cohort 2)
Receives: Drug: Placebo; Drug: Rosuvastatin Dose 1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AZD0780 Concentrations in plasma (PART A)

    To characterise the single dose and steady state PK of AZD0780 following oral administration of AZD0780 (PART A)

    Measured: Day 1 and Day 8: Pre-dose, 0.25,0.5,1,1.5,2,3,4,6,8,12,16 hours post-dose. Day 2, Day 9, Day 11, Day 15, Day 22, Day 29: Pre-dose (PART A)

  2. AZD0780 PK Parameter: AUC0-t (PART A, intensive PK subgroup).

    To characterise the single dose and steady state PK of AZD0780 following oral administration of AZD0780 (PART A)

    Measured: Day 1 and Day 8: Pre-dose, 0.25,0.5,1,1.5,2,3,4,6,8,12,16 hours post-dose. Day 2, Day 9, Day 11, Day 15, Day 22, Day 29: Pre-dose (PART A)

  3. AZD0780 PK parameter: Cmax (PART A, intensive PK subgroup)

    To characterise the single dose and steady state PK of AZD0780 following oral administration of AZD0780 (PART A)

    Measured: Day 1 and Day 8: Pre-dose, 0.25,0.5,1,1.5,2,3,4,6,8,12,16 hours post-dose. Day 2, Day 9, Day 11, Day 15, Day 22, Day 29: Pre-dose (PART A)

  4. AZD0780 PK parameter: AUCtau (PART A, intensive PK sub group)

    To characterise the single dose and steady state PK of AZD0780 following oral administration of AZD0780 (PART A)

    Measured: Day 1 and Day 8: Pre-dose, 0.25,0.5,1,1.5,2,3,4,6,8,12,16 hours post-dose. Day 2, Day 9, Day 11, Day 15, Day 22, Day 29: Pre-dose (PART A)

  5. Relative change in LDL-C from baseline to 12 weeks (PART B)

    To compare the effect of treatment with AZD0780 versus placebo on LDL-C at 12 weeks (PART B)

    Measured: From baseline to 12 weeks (PART B)

Secondary outcomes (8)

  1. Relative change from baseline of LDL-C at Week 4 (PART A)

    To evaluate the effect of treatment with AZD0780 versus placebo on LDL-C at Week 4 (PART A)

    Measured: From baseline to Week 4 (PART A)

  2. Relative change in LDL-C from baseline to 12 weeks (PART B Cohort 2)

    To compare the effect of treatment with AZD0780 versus placebo on LDL-C at 12 weeks in Cohort 2 (PART B)

    Measured: From baseline to 12 weeks (PART B Cohort 2)

  3. Relative change in LDL-C from baseline to 12 weeks (PART B)

    To compare the effect of treatment with AZD0780 versus placebo on LDL-C at 12 weeks in participants on background statin therapy at baseline (PART B)

    Measured: From baseline to 12 weeks (PART B)

  4. Indicator for LDL-C < 70 mg/dL (< 1.8 mmol/L) at 12 weeks (PART B)

    To compare the effect of treatment with AZD0780 versus placebo on the probability of LDL-C < 70 mg/dL at 12 weeks in participants with baseline LDL-C ≥ 70 mg/dL (PART B)

    Measured: From baseline to 12 weeks (PART B)

  5. Indicator for LDL-C < 55 mg/dL (< 1.4 mmol/L) at 12 weeks (PART B)

    To compare the effect of treatment with AZD0780 versus placebo on the probability of LDL-C < 55 mg/dL at 12 weeks (PART B)

    Measured: From baseline to 12 weeks (PART B)

  6. Relative change in LDL-C from baseline to 28 weeks (PART B cohort 1)

    To compare the effect of treatment with AZD0780 versus placebo on LDL-C at 28 weeks in Cohort 1 (PART B cohort 1)

    Measured: From baseline to Week 28 (PART B cohort 1)

  7. Relative change in LDL-C from baseline to 52 weeks (PART B cohort 1)

    To compare the effect of treatment with AZD0780 versus placebo on LDL-C at 52 weeks in Cohort 1 (PART B cohort 1)

    Measured: From baseline to Week 52 (PART B cohort 1)

  8. Relative change in lipid panel from baseline to 12 weeks (PART B cohort 2)

    To compare the effect of treatment with AZD0780 versus placebo on lipid panel at 12 weeks (PART B cohort 2)

    Measured: From baseline to Week 12 (PART B cohort 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2025
  2. Study start6 Dec 2024
  3. Primary completion3 Jul 2025
  4. Study completion22 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
432 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06834932
Sponsor's protocol ID
D7960C00008
Status last verified
Aug 2026
First submitted
2 Dec 2024
Last updated
26 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Rosuvastatin Dose 1, Rosuvastatin dose 2 and AZD0780 in people with Dyslipidaemia, run by AstraZeneca at 42 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in China, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AZD0780 Concentrations in plasma (PART A) (time frame: Day 1 and Day 8: Pre-dose, 0.25,0.5,1,1.5,2,3,4,6,8,12,16 hours post-dose. Day 2, Day 9, Day 11, Day 15, Day 22, Day 29: Pre-dose (PART A)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06834932.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.

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