Clinical Trials List
Protocol Number20230222
Active
2025-08-29 - 2031-12-31
Phase III
Recruiting9
ICD-10R94.39
Abnormal result of other cardiovascular function study
ICD-9794.39
Other abnormal cardiovascular function
A double-blind, randomized, placebo-controlled, multicenter trial was conducted to evaluate the use of Olpasiran in participants with elevated lipoprotein (a) levels to prevent the first major cardiovascular event.
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
IQVIA Co., Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/07/22
Investigators and Locations
Co-Principal Investigator
- CHIH-YUAN WANG Division of General Internal Medicine
- MAO-HSIN LIN Division of General Internal Medicine
- YEN-HUNG LIN Division of General Internal Medicine
- 李弘元 Division of General Internal Medicine
- Tzung-Dau Wang Division of General Internal Medicine
- JEN-KUANG LEE Division of General Internal Medicine
- 陳盈憲 Division of General Internal Medicine
- Chih-Fan Yeh Division of General Internal Medicine
- 林柏志 Division of General Internal Medicine
- 黃慶昌 Division of General Internal Medicine
- 詹其峰 Division of General Internal Medicine
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
- 劉俊傑 Division of Cardiovascular Diseases
- 蘇正煌 Division of Cardiovascular Diseases
- 洪大川 Division of Cardiovascular Diseases
- 郭任遠 Division of Cardiovascular Diseases
- 吳懿哲 Division of Cardiovascular Diseases
- 陳俊延 Division of Cardiovascular Diseases
- 李應湘 Division of Cardiovascular Diseases
- 洪崇烈 Division of Cardiovascular Diseases
- 陳律安 Division of Neurology
- 李俊偉 Division of Cardiovascular Diseases
- 程崇偉 Division of Cardiovascular Diseases
- 林書毅 Division of Cardiovascular Diseases
- 簡禎彥 Division of Cardiovascular Diseases
- 廖峰慶 Division of Cardiovascular Diseases
- 林肇鋒 Division of Cardiovascular Diseases
- 劉亮煦 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Co-Principal Investigator
- 劉文浩 Division of Cardiovascular Diseases
- Huang-Chung Chen Division of Cardiovascular Diseases
- 方燕楠 Division of Cardiovascular Diseases
- 鍾文榮 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Co-Principal Investigator
- Chern-En Chiang Division of Cardiovascular Diseases
- Wen-Chung Yu Division of Cardiovascular Diseases
- Tse-Min Lu Division of Cardiovascular Diseases
- 吳承學 Division of Cardiovascular Diseases
- 李慶威 Division of Cardiovascular Diseases
- 黃偉銘 Division of Cardiovascular Diseases
- 張俊欽 Division of Cardiovascular Diseases
- 蔡依霖 Division of Cardiovascular Diseases
- 蔡泉財 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Co-Principal Investigator
- Chun-Yuan Chu Division of Cardiovascular Diseases
- 吳韋璁 Division of Cardiovascular Diseases
- 黃天祈 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
I-Chang Hsieh
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
The risk of a first major cardiovascular event is associated with elevated lipoprotein (a) (Lp[a]).
Objectives
This is a double-blind, randomized, placebo-controlled, multicenter phase 3 trial evaluating the use of olpasiran (formerly known as AMG 890) to prevent first major cardiovascular events in participants with centrally measured lipoprotein (a) (Lp[a]) ≥ 200 nmol/L. The goal is to recruit approximately 11,000 participants from about 900 trial sites worldwide. This clinical trial is being conducted in collaboration with the Thrombolytic Myocardial Infarction (TIMI) Trial Team at Brigham and Women’s Hospital, affiliated with Harvard Medical School.
Primary Objective
• To assess the impact of olpasiran treatment on the risk of coronary heart disease death (CHD), myocardial infarction, or emergency coronary revascularization in participants with a risk of first major cardiovascular event and elevated lipoprotein (a) (Lp[a]), compared to placebo.
Secondary Objectives
• To assess the impact of olpasiran treatment on the following in participants with a risk of first major cardiovascular event and elevated Lp(a), compared to placebo:
- Cardiovascular death, myocardial infarction, or ischemic stroke
- Cardiovascular death, myocardial infarction, emergency coronary revascularization, or ischemic stroke
• To assess the impact of olpasiran treatment on the change in Lp(a) value from baseline in participants with a risk of first major cardiovascular event and elevated Lp(a), compared to placebo.
Test Drug
AMG 890 (Olpasiran)
Active Ingredient
AMG 890 (Olpasiran)
Dosage Form
subcutaneous injection
Dosage
142 mg/mL
Endpoints
• Assess the impact of olpasiran treatment on the risk of coronary heart disease death (CHD death), myocardial infarction, or emergency coronary revascularization compared to placebo in participants with a risk of first major cardiovascular event and elevated lipoprotein (a) (Lp[a]).
Inclution Criteria
To be eligible for inclusion in this trial, participants must meet all of the following criteria:
101. Participants have provided written subject consent before commencing any trial-specified activity or procedure.
102. Participants are 50 years of age or older at the time of signing the Lp(a) screening subject consent form.
103. At the time of Lp(a) screening, the Lp(a) level measured by the central laboratory using experimental IVD is ≥ 200 nmol/L.
• Prior to Lp(a) screening, participants have received at least 4 weeks of stable, optimized lipid-lowering therapy that conforms to regional/local clinical practice guidelines or, as determined by the trial administrator.
104 participants who meet at least one of the following categories (A or B):
A. Multiple risk factors for atherosclerotic disease
1. Having ≥ 4 of the following ASCVD risk factors:
a. Age ≥ 65 years, male or female
b. History of hypertension requiring medication
c. Current smoking
d. Diabetes (type 1 or type 2) requiring medication
e. High-sensitivity C-reactive protein (hs-CRP) at the central laboratory at screening time ≥ 2.0 mg/L
f. Estimated glomerular filtration rate (eGFR) at the central laboratory at screening time 30 to < 60 mL/min/1.73 m2
g. Family history of familial hypercholesterolemia or early-onset ASCVD (male first-degree relative with ASCVD before age 55, and/or female first-degree relative with ASCVD before age 65). A. A history of atherosclerosis, with the following evidence:
1. Coronary Artery Disease Reporting and Data System (CAD-RADS) classification P3, and/or
2. Coronary Artery Calcification (CAC) score > 300, and/or
3. Atherosclerosis is defined as having at least one of the following, and having ≥ 2 other risk factors:
a. Coronary atherosclerosis, manifested as stenosis ≥ 50% in at least one artery
b. Coronary atherosclerosis, manifested as stenosis ≥ 25% in at least two arteries detected by invasive or non-invasive imaging (or reported as at least mild)
c. Coronary atherosclerosis, manifested as CAC score > 100 and/or CAD-RADS classification ≥ P2
d. Carotid atherosclerosis, manifested as internal carotid artery stenosis ≥ 50%
e. Peripheral atherosclerosis, manifested as limb artery stenosis ≥ 50% and/or ankle-brachial index <0.9
101. Participants have provided written subject consent before commencing any trial-specified activity or procedure.
102. Participants are 50 years of age or older at the time of signing the Lp(a) screening subject consent form.
103. At the time of Lp(a) screening, the Lp(a) level measured by the central laboratory using experimental IVD is ≥ 200 nmol/L.
• Prior to Lp(a) screening, participants have received at least 4 weeks of stable, optimized lipid-lowering therapy that conforms to regional/local clinical practice guidelines or, as determined by the trial administrator.
104 participants who meet at least one of the following categories (A or B):
A. Multiple risk factors for atherosclerotic disease
1. Having ≥ 4 of the following ASCVD risk factors:
a. Age ≥ 65 years, male or female
b. History of hypertension requiring medication
c. Current smoking
d. Diabetes (type 1 or type 2) requiring medication
e. High-sensitivity C-reactive protein (hs-CRP) at the central laboratory at screening time ≥ 2.0 mg/L
f. Estimated glomerular filtration rate (eGFR) at the central laboratory at screening time 30 to < 60 mL/min/1.73 m2
g. Family history of familial hypercholesterolemia or early-onset ASCVD (male first-degree relative with ASCVD before age 55, and/or female first-degree relative with ASCVD before age 65). A. A history of atherosclerosis, with the following evidence:
1. Coronary Artery Disease Reporting and Data System (CAD-RADS) classification P3, and/or
2. Coronary Artery Calcification (CAC) score > 300, and/or
3. Atherosclerosis is defined as having at least one of the following, and having ≥ 2 other risk factors:
a. Coronary atherosclerosis, manifested as stenosis ≥ 50% in at least one artery
b. Coronary atherosclerosis, manifested as stenosis ≥ 25% in at least two arteries detected by invasive or non-invasive imaging (or reported as at least mild)
c. Coronary atherosclerosis, manifested as CAC score > 100 and/or CAD-RADS classification ≥ P2
d. Carotid atherosclerosis, manifested as internal carotid artery stenosis ≥ 50%
e. Peripheral atherosclerosis, manifested as limb artery stenosis ≥ 50% and/or ankle-brachial index <0.9
Exclusion Criteria
Participants will be excluded from the trial if they meet any of the following criteria: Disease-Related
201. A history of acute atherosclerotic thrombotic events at any time in the past, defined as a previous myocardial infarction, stroke, transient ischemic attack, or acute limb ischemia.
202. A history of arterial revascularization procedures suspected to be related to atherosclerosis at any time in the past.
203. If data is available, the participant has no known atherosclerosis within the 10 years prior to enrollment, with a CAC score of 0 and CAD-RADS of 0.
204. Severe renal impairment, defined as an eGFR < 30 mL/min/1.73 m² at the central laboratory at screening time.
205. History of uncompensated cirrhosis, and/or aspartate transaminase (AST) or alanine transaminase (ALT) > 3 times the upper limit of normal (ULN) or total bilirubin (TBL) > 2 times the ULN at screening time (excluding stable Gilbert's syndrome).
206. History of major bleeding disorders (e.g., hemophilia, von Willebrand disease, clotting factor deficiency, etc.).
207. Scheduled for arterial revascularization (percutaneous or surgical).
Diagnostic Assessment
208. Fasting triglycerides > 400 mg/dL (4.52 mmol/L) at screening.
Other Medical Conditions
209. Known allergy to any product or ingredient to be used in the administration or trial procedure.
210. No remission of malignant tumors for at least 5 years prior to enrollment. Exceptions for remission less than 5 years include: non-melanoma skin cancer, localized thyroid cancer (papillary, follicular, medullary), cervical carcinoma in situ, ductal carcinoma in situ, or stage I prostate cancer.
211. Diagnosis of severe heart failure (New York Heart Association functional class IV) and/or a recent [if available] known left ventricular ejection fraction < 30%.
212. History or recurrence of poorly controlled ventricular tachycardia within the 3 months prior to inclusion.
213. Atrial fibrillation or flutter with symptoms indicating the need for anticoagulation therapy but not currently using anticoagulants.
214. Poorly controlled hypertension at screening, defined as systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg at rest, despite the use of antihypertensive therapy.
215. Diabetes mellitus (type 1 or type 2) with a central laboratory heme A1c (HbA1c) ≥ 10% at screening.
216. History or evidence of other significant clinical abnormalities, conditions, or diseases (e.g., active infection) that, according to the trial administrator or Amgen physician (if consulted), may jeopardize participant safety or affect trial evaluation, procedures, or completion.
Previous/Current Concomitant Treatments
217 Currently undergoing or scheduled for lipoprotein chelation therapy, or the interval between the last chelation therapy and enrollment is < 3 months.
218 Participant has used cholesterol ester transfer protein inhibitors or lomitapide within 12 months prior to enrollment.
219 Previously received any treatment targeting Lp(a), including but not limited to olpasiran, pelacarsen, lepodisiran, zerlasiran, or muvalaplin.
Previous/Current Concomitant Participation in Other Clinical Trials
220 Currently receiving treatment with other investigational devices or investigational drugs, or having completed treatment with other investigational devices or investigational drugs less than 30 days ago. Participation in other trial procedures is not permitted at the time of enrollment in this trial.
Other Exclusion Criteria
221. Participants of childbearing potential who do not wish to use the contraceptive method specified in the trial protocol during treatment and for an additional 30 days after the last dose of the investigational drug.
222. Participants who are breastfeeding, or participants who plan to breastfeed during the trial and for 30 days after the last dose of the investigational drug.
223. Participants who plan to conceive during the trial period up to 30 days after the last dose of the investigational drug.
224. Participants of fertility who have a positive result on a high-sensitivity urine or serum pregnancy test at screening and/or on day 1.
225. To the best of the participant's and the trial administrator's knowledge, the participant may be unable to complete all trial follow-ups or procedures prescribed by the trial plan, and/or cooperate with all prescribed trial procedures (e.g., clinical outcome assessment).
201. A history of acute atherosclerotic thrombotic events at any time in the past, defined as a previous myocardial infarction, stroke, transient ischemic attack, or acute limb ischemia.
202. A history of arterial revascularization procedures suspected to be related to atherosclerosis at any time in the past.
203. If data is available, the participant has no known atherosclerosis within the 10 years prior to enrollment, with a CAC score of 0 and CAD-RADS of 0.
204. Severe renal impairment, defined as an eGFR < 30 mL/min/1.73 m² at the central laboratory at screening time.
205. History of uncompensated cirrhosis, and/or aspartate transaminase (AST) or alanine transaminase (ALT) > 3 times the upper limit of normal (ULN) or total bilirubin (TBL) > 2 times the ULN at screening time (excluding stable Gilbert's syndrome).
206. History of major bleeding disorders (e.g., hemophilia, von Willebrand disease, clotting factor deficiency, etc.).
207. Scheduled for arterial revascularization (percutaneous or surgical).
Diagnostic Assessment
208. Fasting triglycerides > 400 mg/dL (4.52 mmol/L) at screening.
Other Medical Conditions
209. Known allergy to any product or ingredient to be used in the administration or trial procedure.
210. No remission of malignant tumors for at least 5 years prior to enrollment. Exceptions for remission less than 5 years include: non-melanoma skin cancer, localized thyroid cancer (papillary, follicular, medullary), cervical carcinoma in situ, ductal carcinoma in situ, or stage I prostate cancer.
211. Diagnosis of severe heart failure (New York Heart Association functional class IV) and/or a recent [if available] known left ventricular ejection fraction < 30%.
212. History or recurrence of poorly controlled ventricular tachycardia within the 3 months prior to inclusion.
213. Atrial fibrillation or flutter with symptoms indicating the need for anticoagulation therapy but not currently using anticoagulants.
214. Poorly controlled hypertension at screening, defined as systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg at rest, despite the use of antihypertensive therapy.
215. Diabetes mellitus (type 1 or type 2) with a central laboratory heme A1c (HbA1c) ≥ 10% at screening.
216. History or evidence of other significant clinical abnormalities, conditions, or diseases (e.g., active infection) that, according to the trial administrator or Amgen physician (if consulted), may jeopardize participant safety or affect trial evaluation, procedures, or completion.
Previous/Current Concomitant Treatments
217 Currently undergoing or scheduled for lipoprotein chelation therapy, or the interval between the last chelation therapy and enrollment is < 3 months.
218 Participant has used cholesterol ester transfer protein inhibitors or lomitapide within 12 months prior to enrollment.
219 Previously received any treatment targeting Lp(a), including but not limited to olpasiran, pelacarsen, lepodisiran, zerlasiran, or muvalaplin.
Previous/Current Concomitant Participation in Other Clinical Trials
220 Currently receiving treatment with other investigational devices or investigational drugs, or having completed treatment with other investigational devices or investigational drugs less than 30 days ago. Participation in other trial procedures is not permitted at the time of enrollment in this trial.
Other Exclusion Criteria
221. Participants of childbearing potential who do not wish to use the contraceptive method specified in the trial protocol during treatment and for an additional 30 days after the last dose of the investigational drug.
222. Participants who are breastfeeding, or participants who plan to breastfeed during the trial and for 30 days after the last dose of the investigational drug.
223. Participants who plan to conceive during the trial period up to 30 days after the last dose of the investigational drug.
224. Participants of fertility who have a positive result on a high-sensitivity urine or serum pregnancy test at screening and/or on day 1.
225. To the best of the participant's and the trial administrator's knowledge, the participant may be unable to complete all trial follow-ups or procedures prescribed by the trial plan, and/or cooperate with all prescribed trial procedures (e.g., clinical outcome assessment).
The Estimated Number of Participants
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Taiwan
90 participants
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Global
11000 participants
