Clinical Trials List
Protocol NumberD7960C00012
Active
2025-06-01 - 2027-12-31
Phase III
Recruiting8
ICD-10E78.2
Mixed hyperlipidemia
ICD-9272.2
Mixed hyperlipidemia
A Phase III, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Effect of AZD0780 on Low Density Lipoprotein Cholesterol in Patients With Elevated Low-Density Lipoprotein Cholesterol and Clinical Atherosclerotic Cardiovascular Disease or at Risk for a First Atherosclerotic Cardiovascular Disease Event
-
Trial Applicant
-
Sponsor
AstraZeneca AB
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 張之昀 Division of Endocrinology
- 蔡易婷 Division of Endocrinology
- 梁凱偉 Division of Cardiovascular Diseases
- 鄭諭聰 Division of Cardiovascular Diseases
- 李佳霖 Division of Endocrinology
- 傅家保 Division of Endocrinology
- WEI-WEN LIN Division of Cardiovascular Diseases
- Tsun-Jui Liu Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 林志弘 Division of General Internal Medicine
- HUNG-JU LIN Division of Cardiovascular Diseases
- YEN-HUNG LIN Division of Cardiovascular Diseases
- 張恬君 Division of General Internal Medicine
- 吳婉禎 Division of General Internal Medicine
- MAO-HSIN LIN Division of Cardiovascular Diseases
- SUNG-CHUN TANG Division of Neurology
- 呂金盈 Division of General Internal Medicine
- 林家宏 Division of General Internal Medicine
- 嚴愛文 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 徐莞嘉 Division of Endocrinology
- 陳玟潔 Division of Endocrinology
- 沈峰志 Division of Endocrinology
- 柴漢東 Division of Cardiovascular Diseases
- 陳建仁 Division of Cardiovascular Diseases
- 周依文 Division of Endocrinology
- 郭銘俊 Division of Endocrinology
- 林麗珊 Division of Endocrinology
- 陳永年 Division of Endocrinology
- 蔡嘉仁 Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 張俊欽 Division of Cardiovascular Diseases
- 黃偉銘 Division of Cardiovascular Diseases
- Chern-En Chiang Division of Cardiovascular Diseases
- 張皓智 Division of Cardiovascular Diseases
- 蔡依霖 Division of Cardiovascular Diseases
- Wen-Chung Yu Division of Cardiovascular Diseases
- 曾致學 Division of General Internal Medicine
- 蔡泉財 Division of Cardiovascular Diseases
- Shih-Hsien Sung Division of Cardiovascular Diseases
- 黃偉杰 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chun-Yuan Chu Division of Cardiovascular Diseases
- Ye-Hsu Lu Division of Cardiovascular Diseases
- 吳韋璁 Division of Cardiovascular Diseases
- Po-Chao Hsu Division of Cardiovascular Diseases
- 卓士傑 Division of Cardiovascular Diseases
- 黃天祈 Division of Cardiovascular Diseases
- 朱志生 Division of Cardiovascular Diseases
- 林子傑 Division of Cardiovascular Diseases
- Wei-Chung Tsai Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Hsi-Hsien Chen
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Atherosclerotic Cardiovascular Disease
Objectives
To compare the effect of treatment with AZD0780
versus placebo on LDL-C at 12 weeks
Test Drug
tablet
Active Ingredient
AZD0780
Dosage Form
110
Dosage
30 MG
Endpoints
Relative change in LDL-C from baseline to 12
weeks
weeks
Inclution Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
Age
1 ≥ 18 years of age at the time of signing the ICF
Type of Participant and Disease Characteristics
2 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.
3 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
4 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 guidelines1 OR:
(ii) A lower intensity statin regimen in combination with ezetimibe and/or
bempedoic acid2:
OR:
− A maximum tolerated statin regimen3 - 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.
Sex and Contraceptive/Barrier Requirements
5 Male and/or female assigned at birth, inclusive of all gender identities.
6 WOCBP who are sexually active with a non-sterilised male partner(s) must be on an
established highly effective form of birth control from screening throughout the study and
should continue with highly effective birth control for at least 10 days after last dose of
IMP. A highly effective method of contraception is defined as one that can achieve a
failure rate of less than 1% per year when used consistently and correctly. Such methods
include:
− Systemic hormonal contraception associated with inhibition of ovulation
(oral/transdermal/injectable/implantable/intravaginal)
− Intrauterine device/intrauterine hormone-releasing system
− Bilateral tubal occlusion/vasectomised partner(s)
Additionally, a barrier method of contraception must be used: condoms (male or female)
with or without a spermicidal agent, diaphragm, or cervical cap with spermicide.
Total sexual abstinence is an acceptable method provided it is the usual lifestyle of the
participant (defined as refraining from heterosexual intercourse during the entire period of
risk associated with the study treatments).
Periodic abstinence (calendar, ovulation, symptothermal, post-ovulation methods),
withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea are not
acceptable methods of contraception.
7 Female participants of non-childbearing potential are defined as females who are either
permanently sterilised (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy)
or who are postmenopausal. Females will be considered postmenopausal if they have
been amenorrhoeic for 12 months or more following cessation of exogenous hormonal
treatment. A high FSH level in the postmenopausal range, which will depend on the
normative data for the specific assay used, may also be used to confirm a postmenopausal
state. At least 2 FSH levels (at least 4 weeks apart) should be within postmenopausal
range. If hormonal replacement therapy is discontinued, the first of the 2 consecutive FSH
levels should be done at least 6 weeks from stopping hormonal replacement therapy.
Age
1 ≥ 18 years of age at the time of signing the ICF
Type of Participant and Disease Characteristics
2 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.
3 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
4 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 guidelines1 OR:
(ii) A lower intensity statin regimen in combination with ezetimibe and/or
bempedoic acid2:
OR:
− A maximum tolerated statin regimen3 - 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.
Sex and Contraceptive/Barrier Requirements
5 Male and/or female assigned at birth, inclusive of all gender identities.
6 WOCBP who are sexually active with a non-sterilised male partner(s) must be on an
established highly effective form of birth control from screening throughout the study and
should continue with highly effective birth control for at least 10 days after last dose of
IMP. A highly effective method of contraception is defined as one that can achieve a
failure rate of less than 1% per year when used consistently and correctly. Such methods
include:
− Systemic hormonal contraception associated with inhibition of ovulation
(oral/transdermal/injectable/implantable/intravaginal)
− Intrauterine device/intrauterine hormone-releasing system
− Bilateral tubal occlusion/vasectomised partner(s)
Additionally, a barrier method of contraception must be used: condoms (male or female)
with or without a spermicidal agent, diaphragm, or cervical cap with spermicide.
Total sexual abstinence is an acceptable method provided it is the usual lifestyle of the
participant (defined as refraining from heterosexual intercourse during the entire period of
risk associated with the study treatments).
Periodic abstinence (calendar, ovulation, symptothermal, post-ovulation methods),
withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea are not
acceptable methods of contraception.
7 Female participants of non-childbearing potential are defined as females who are either
permanently sterilised (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy)
or who are postmenopausal. Females will be considered postmenopausal if they have
been amenorrhoeic for 12 months or more following cessation of exogenous hormonal
treatment. A high FSH level in the postmenopausal range, which will depend on the
normative data for the specific assay used, may also be used to confirm a postmenopausal
state. At least 2 FSH levels (at least 4 weeks apart) should be within postmenopausal
range. If hormonal replacement therapy is discontinued, the first of the 2 consecutive FSH
levels should be done at least 6 weeks from stopping hormonal replacement therapy.
Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions
1 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.
2 Uncontrolled severe hypertension: systolic BP > 160 mmHg or diastolic BP > 110 mmHg
at randomisation despite antihypertensive therapy (based on the mean of the
3 consecutive readings).
3 Severe concomitant non-CV disease with risk of life expectancy less than 2 years
4 Malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma) within
3 years prior to screening
5 Any of the following laboratory values at screening:
− Calculated eGFR < 15 mL/min/1.73 m2 (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 > 5 × ULN
− Urine albumin-to-creatinine ratio ≥ 500 mg/g
6 For women only: currently pregnant (confirmed with positive pregnancy test at screening
or randomisation) or breast-feeding or planning to become pregnant during the study
7 Criterion not applicable to this version of the CSP
8 Criterion not applicable to this version of the CSP
9 Criterion not applicable to this version of the CSP
10 Criterion not applicable to this version of the CSP
11 Criterion not applicable to this version of the CSP
12 Criterion not applicable to this version of the CSP
13 Known history of alcohol and/or drug abuse within 5 years prior to screening
14 Recipient of any major organ transplant, eg, lung, liver, heart, bone marrow, renal
15 History of hypersensitivity to AZD0780 or drugs with a similar chemical structure or
known prior intolerance to AZD0780
16 Uncontrolled type 2 diabetes mellitus defined as HbA1c ≥ 9.5% at screening
17 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
18 Any uncontrolled or serious disease, or any medical (eg, known major active infection
[eg, hepatitis B and C] or major CV, haematological, renal, metabolic, gastrointestinal,
respiratory, hepatic, or endocrine dysfunction) or surgical condition that, in the opinion of
the Investigator, may either interfere with participation in the clinical study and/or put the
participant at significant risk
Medical Conditions
1 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.
2 Uncontrolled severe hypertension: systolic BP > 160 mmHg or diastolic BP > 110 mmHg
at randomisation despite antihypertensive therapy (based on the mean of the
3 consecutive readings).
3 Severe concomitant non-CV disease with risk of life expectancy less than 2 years
4 Malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma) within
3 years prior to screening
5 Any of the following laboratory values at screening:
− Calculated eGFR < 15 mL/min/1.73 m2 (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 > 5 × ULN
− Urine albumin-to-creatinine ratio ≥ 500 mg/g
6 For women only: currently pregnant (confirmed with positive pregnancy test at screening
or randomisation) or breast-feeding or planning to become pregnant during the study
7 Criterion not applicable to this version of the CSP
8 Criterion not applicable to this version of the CSP
9 Criterion not applicable to this version of the CSP
10 Criterion not applicable to this version of the CSP
11 Criterion not applicable to this version of the CSP
12 Criterion not applicable to this version of the CSP
13 Known history of alcohol and/or drug abuse within 5 years prior to screening
14 Recipient of any major organ transplant, eg, lung, liver, heart, bone marrow, renal
15 History of hypersensitivity to AZD0780 or drugs with a similar chemical structure or
known prior intolerance to AZD0780
16 Uncontrolled type 2 diabetes mellitus defined as HbA1c ≥ 9.5% at screening
17 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
18 Any uncontrolled or serious disease, or any medical (eg, known major active infection
[eg, hepatitis B and C] or major CV, haematological, renal, metabolic, gastrointestinal,
respiratory, hepatic, or endocrine dysfunction) or surgical condition that, in the opinion of
the Investigator, may either interfere with participation in the clinical study and/or put the
participant at significant risk
The Estimated Number of Participants
-
Taiwan
120 participants
-
Global
2800 participants
