New pill could help control high cholesterol – study underway

NCT ID NCT06834932

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 2 times

Summary

This study tests an experimental oral drug called AZD0780 in 432 adults with high LDL cholesterol (dyslipidaemia). Participants take the drug or a placebo daily for up to 52 weeks to see if it safely lowers cholesterol. The goal is to manage the condition, not cure it, as ongoing treatment is needed.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

432 people

The number who actually took part.

Started

Dec 2024

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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) 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: 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 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.

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Conditions

The condition(s) this trial relates to.

Dyslipidemias inherited lipid metabolism disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dyslipidaemia

Contacts and locations

Locations

Research Site

Baotou, 14010, China
Research Site

Beijing, 100029, China
Research Site

Beijing, 100050, China
Research Site

Bengbu, 233004, China
Research Site

Changchun, 130021, China
Research Site

Changchun, 130033, China
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Changde, 415000, China
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Changsha, 410015, China
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Changzhou, 272100, China
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Chengdu, 610000, China
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Chongqing, 402260, China
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Daqing, 163000, China
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Deyang, 618000, China
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Guangzhou, 510100, China
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Guangzhou, 510220, China
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Hengyang, 421001, China
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Heze, 274099, China
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Linhai, 317000, China
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Luoyang, 471000, China
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Nanchang, 330009, China
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Nanchong, 637900, China
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Nanjing, 210009, China
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Pingxiang, 337055, China
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Qiqihar, 161000, China
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Sanya, 572000, China
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Shanghai, 200032, China
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Shanghai, 200120, China
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Shanghai, 310000, China
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Shenyang, 110004, China
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Shenyang, 110016, China
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Siping, 136000, China
Research Site

Taiyuan, 030024, China
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Tianjin, 300457, China
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Wuhan, 430010, China
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Wuhan, 430030, China
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Wuhan, 430060, China
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Xi'an, 710068, China
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Xianyang, 750004, China
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Yinchuan, 750004, China
Research Site

Zigong, 643021, China
Research Site

Hong Kong, 999077, Hong Kong
Research Site

Shatin, 00000, Hong Kong

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