A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of AZD0780 in Participants With Dyslipidaemia
NCT ID: NCT06834932
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
360 participants
INTERVENTIONAL
2024-12-06
2027-06-18
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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AZD0780 +Rosuvastatin Dose 1 (Part A)
* 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)
Rosuvastatin Dose 1
Administered orally as tablets
AZD0780
Administered orally as tablets
Placebo +Rosuvastatin Dose 1 (Part A)
* 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)
Placebo
Administered orally as tablets
Rosuvastatin Dose 1
Administered orally as tablets
AZD0780 +Rosuvastatin Dose 2 (Part A)
* 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)
Rosuvastatin dose 2
Administered orally as tablets
AZD0780
Administered orally as tablets
Placebo + Rosuvastatin Dose 2 (Part A)
* 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)
Placebo
Administered orally as tablets
Rosuvastatin dose 2
Administered orally as tablets
AZD0780 (Part B Cohort 1)
• Participate will receive AZD0780 QD for 52 weeks (Part B Cohort 1)
AZD0780
Administered orally as tablets
Placebo (Part B Cohort 1)
• Participate will receive Placebo QD for 52 weeks (Part B Cohort 1)
Placebo
Administered orally as tablets
AZD0780+Rosuvastatin Dose 1 (Part B Cohort 2)
* Participate receive Rosuvastatin Dose 1 for 28 days.
* Then receive AZD0780 QD as add on for 12 weeks (Part B Cohort 2)
Rosuvastatin Dose 1
Administered orally as tablets
AZD0780
Administered orally as tablets
Placebo+Rosuvastation Dose 1 (Part B Cohort 2)
* Participate receive Rosuvastatin Dose 1 for 28 days.
* Then receive Placebo QD as add on for 12 weeks (Part B Cohort 2)
Placebo
Administered orally as tablets
Rosuvastatin Dose 1
Administered orally as tablets
Interventions
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Placebo
Administered orally as tablets
Rosuvastatin Dose 1
Administered orally as tablets
Rosuvastatin dose 2
Administered orally as tablets
AZD0780
Administered orally as tablets
Eligibility Criteria
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Inclusion Criteria
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) Participants with clinical ASCVD, LDL-C ≥ 55 mg/dl (ultra-high risk) and ≥ 70 mg/dl (very high risk).
(2) 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).
1. Participants intolerant to moderate or high intensity statins per the 2023 Chinese Guideline may be included if treated with a low intensity statin.
2. 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):
1. On a stable dose of LLTs including moderate statins .
2. On a stable dose of LLTs without any statins.
3. Not received treatment with any LLTs.
Exclusion Criteria
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 ASCVD event within 7 days prior to screening (Visit 1).
2. Any uncontrolled or serious disease.
3. eGFR \< 15 mL/min/1.73m2 using the CKD-EPI 2021 (age, sex) equation at screening (Visit 1).
4. Uncontrolled type 2 diabetes mellitus, defined as HbA1c ≥ 9.5% 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) 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 \> 110 mmHg at screening (Visit 1) or randomization despite antihypertensive therapy (based on the mean of the 3 consecutive readings).
11. Any laboratory values with the following deviations at screening (Visit 1)
1. Any positive result on screening for hepatitis B or hepatitis C.
2. ALT \> 3 × ULN.
3. AST \> 3 × ULN.
4. TBL \> 2 × ULN (except for participants with Gilberts syndrome, where TBL 3 × ULN is acceptable provided direct bilirubin \< 1.5 × ULN)
5. Creatine kinase \> 5 × ULN
6. Urine albumin-to-creatinine ratio ≥ 500 mg/g
12. QTcF \> 470 ms; high degree atrioventricular-block grade II-III and sinus node dysfunction with significant sinus pause untreated with pacemaker; and cardiac tachyarrhythmias.
13. Current administration of PCSK9 inhibitor, siRNA or mAb (approved or investigational) at screening.
14. Mipomersen or microsomal triglyceride transfer protein inhibitor (eg, lomitapide) use within 12 months prior to screening or planned ues during the study.
15. 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.
16. Use of any lipid-lowing traditional Chinese medicine (expect Xuezhikang) within 8 weeks before screening.
17. Use of gemfibrozil within one week before screening or planned use during the study.
18. Receiving, or has received within 14 days of screening, medication with a black box warning for significant QT prolongation.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Baotou, , China
Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Bengbu, , China
Research Site
Changchun, , China
Research Site
Changchun, , China
Research Site
Changde, , China
Research Site
Changsha, , China
Research Site
Changzhou, , China
Research Site
Chengdu, , China
Research Site
Chongqing, , China
Research Site
Daqing, , China
Research Site
Deyang, , China
Research Site
Guangzhou, , China
Research Site
Guangzhou, , China
Research Site
Hengyang, , China
Research Site
Heze, , China
Research Site
Linhai, , China
Research Site
Luoyang, , China
Research Site
Nanchang, , China
Research Site
Nanchong, , China
Research Site
Nanjing, , China
Research Site
Pingxiang, , China
Research Site
Qiqihar, , China
Research Site
Sanya, , China
Research Site
Shanghai, , China
Research Site
Shanghai, , China
Research Site
Shanghai, , China
Research Site
Shenyang, , China
Research Site
Shenyang, , China
Research Site
Siping, , China
Research Site
Taiyuan, , China
Research Site
Tianjin, , China
Research Site
Wuhan, , China
Research Site
Wuhan, , China
Research Site
Wuhan, , China
Research Site
Xi'an, , China
Research Site
Xianyang, , China
Research Site
Yinchuan, , China
Research Site
Zigong, , China
Research Site
Hong Kong, , Hong Kong
Research Site
Hong Kong, , Hong Kong
Research Site
Shatin, , Hong Kong
Countries
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Central Contacts
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Other Identifiers
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D7960C00008
Identifier Type: -
Identifier Source: org_study_id