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.
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
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
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 group | Role | What 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.
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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.
- First posted19 Feb 2025
- Study start6 Dec 2024
- Primary completion3 Jul 2025
- Study completion22 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidaemiaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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.