Authorised Therapeutic confirmatory (Phase III) Hyperlipidemia

A Study to Find Out How Safe and Well AZD0780 Works for Adults with High 'Bad' Cholesterol and with Heart- Stroke or Vascular Disease or at risk for Such Disease

EU CTIS ID: 2025-520521-21-00

What this study is testing

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

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • ≥ 18 years of age at the time of signing the ICF
  • History of clinical ASCVD or at risk for a first ASCVD event: (a) Clinical ASCVD is defined as MI, stable or unstable angina, coronary or other arterial revascularisation, ischaemic stroke, or peripheral artery disease. (b) A participant is considered at risk for a first ASCVD event if the participant has one or more of the following conditions: atherosclerotic vascular disease (≥ 50% stenosis in ≥ 2 coronary artery territories or in ≥ 2 vascular beds [coronary, carotid, lower extremity], diagnosed by any imaging modality), diabetes mellitus, hypertension, cigarette smoking, chronic kidney disease (moderate to severe stage), or obesity. Investigators can also use the ACC/AHA or ESC or other relevant national clinical guidelines for risk assessment to identify participants with at least moderate risk for ASCVD.
  • Fasting serum LDL-C by central laboratory at screening as follows: LDL-C ≥ 55 mg/dL (≥ 1.4 mmol/L) in participants with clinical ASCVD; or ≥ 70 mg/dL (≥ 1.8 mmol/L) in participants without clinical ASCVD but at risk for a first ASCVD event
  • Participants should receive a background lipid lowering regimen anticipated to achieve at least a ~50% reduction in LDL-C. Except in cases of intolerance, the regimen should include a high-intensity statin therapy or lower intensity statin therapy in combination with an oral agent with proven outcome benefit (eg, ezetimibe and/or bempedoic acid). Thus, the background lipid-lowering therapy must consist of one of the following: − A high-intensity LDL lowering regimen (i) A high intensity statin regimen, as defined by country specific guidelines OR: (ii) A lower intensity statin regimen in combination with ezetimibe and/or bempedoic acid OR: − A maximum tolerated statin regimen - Oral combination therapy with ezetimibe and/or bempedoic acid is strongly recommended. Participants must achieve a stable background lipid-lowering therapy > 28 days before screening.

You likely can't join if

  • Homozygous familial hypercholesterolaemia, known diagnosis of HeFH, 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.
  • Any of the following laboratory values at screening: Calculated eGFR < 15 mL/min/1.73 m^2 (CKD-EPI formula; Delgado et al 2022, Inker et al 2021) AST or ALT > 3 × ULN TBL > 2 × ULN (except for patients with Gilberts syndrome, where TBL 3 × ULN is acceptable provided direct bilirubin < 1.5 × ULN) Fasting triglycerides ≥ 400 mg/dL (≥ 4.52 mmol/L) Creatine Kinase > 5X ULN Urine albumin to creatinine ratio ≥ 500 mg/g
  • Uncontrolled type 2 diabetes mellitus defined as HbA1c ≥ 9.5% at screening
  • Inadequately treated hypothyroidism defined as TSH > 1.5 ULN at screening or participants whose thyroid replacement therapy was initiated or modified within the last 3 months prior to screening
  • Use of mipomersen or lomitapide (cholesterol-lowering medications) within 12 months prior to screening or planned use during the study
  • Use of gemfibrozil within 1 week prior to screening or planned use during the study
See the full eligibility criteria
Who can join
  • ≥ 18 years of age at the time of signing the ICF
  • History of clinical ASCVD or at risk for a first ASCVD event: (a) Clinical ASCVD is defined as MI, stable or unstable angina, coronary or other arterial revascularisation, ischaemic stroke, or peripheral artery disease. (b) A participant is considered at risk for a first ASCVD event if the participant has one or more of the following conditions: atherosclerotic vascular disease (≥ 50% stenosis in ≥ 2 coronary artery territories or in ≥ 2 vascular beds [coronary, carotid, lower extremity], diagnosed by any imaging modality), diabetes mellitus, hypertension, cigarette smoking, chronic kidney disease (moderate to severe stage), or obesity. Investigators can also use the ACC/AHA or ESC or other relevant national clinical guidelines for risk assessment to identify participants with at least moderate risk for ASCVD.
  • Fasting serum LDL-C by central laboratory at screening as follows: LDL-C ≥ 55 mg/dL (≥ 1.4 mmol/L) in participants with clinical ASCVD; or ≥ 70 mg/dL (≥ 1.8 mmol/L) in participants without clinical ASCVD but at risk for a first ASCVD event
  • Participants should receive a background lipid lowering regimen anticipated to achieve at least a ~50% reduction in LDL-C. Except in cases of intolerance, the regimen should include a high-intensity statin therapy or lower intensity statin therapy in combination with an oral agent with proven outcome benefit (eg, ezetimibe and/or bempedoic acid). Thus, the background lipid-lowering therapy must consist of one of the following: − A high-intensity LDL lowering regimen (i) A high intensity statin regimen, as defined by country specific guidelines OR: (ii) A lower intensity statin regimen in combination with ezetimibe and/or bempedoic acid OR: − A maximum tolerated statin regimen - Oral combination therapy with ezetimibe and/or bempedoic acid is strongly recommended. Participants must achieve a stable background lipid-lowering therapy > 28 days before screening.
What rules you out
  • Homozygous familial hypercholesterolaemia, known diagnosis of HeFH, 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.
  • Any of the following laboratory values at screening: Calculated eGFR < 15 mL/min/1.73 m^2 (CKD-EPI formula; Delgado et al 2022, Inker et al 2021) AST or ALT > 3 × ULN TBL > 2 × ULN (except for patients with Gilberts syndrome, where TBL 3 × ULN is acceptable provided direct bilirubin < 1.5 × ULN) Fasting triglycerides ≥ 400 mg/dL (≥ 4.52 mmol/L) Creatine Kinase > 5X ULN Urine albumin to creatinine ratio ≥ 500 mg/g
  • Uncontrolled type 2 diabetes mellitus defined as HbA1c ≥ 9.5% at screening
  • Inadequately treated hypothyroidism defined as TSH > 1.5 ULN at screening or participants whose thyroid replacement therapy was initiated or modified within the last 3 months prior to screening
  • Use of mipomersen or lomitapide (cholesterol-lowering medications) within 12 months prior to screening or planned use during the study
  • Use of gemfibrozil within 1 week prior to screening or planned use during the study
  • Use of PCSK-9 inhibitors: evolocumab/alirocumab within 12 weeks of the screening visit or planned use during the study or inclisiran within 18 months of the screening visit or planned use during the study. Any other approved PCSK-9 inhibitor use within 5 half lives prior to the screening visit or planned use during the study.

The study team makes the final eligibility decision.

Where it's taking place

  • Turkey
  • Australia
  • Argentina
  • Brazil
  • Chile
  • Ukraine
  • Korea, Republic of
  • Taiwan
  • Vietnam
  • India
  • United Kingdom
  • Canada
  • Japan
  • Malaysia
  • United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Turkey; Australia; Argentina; Brazil; Chile; Ukraine and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

ObesityType 2 diabetesType 1 diabetesPrediabetesWeight lossMetabolic syndromeHigh cholesterolHigh triglyceridesHigh blood pressurePCOSHypothyroidismThyroid diseaseGoutFatty liver disease (NAFLD/NASH)Heart failureCoronary artery disease

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.