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| ID | Type | Description | Link |
|---|---|---|---|
| J2O-MC-EKBC | Other Identifier | Eli Lilly and Company | |
| 2022-501466-21-00 | EU Trial (CTIS) Number |
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The main purpose of this study is to evaluate the efficacy and safety of LY3473329 in adult participants with elevated Lp(a) at high risk for cardiovascular events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10 mg LY3473329 | Experimental | Participants received 10 milligrams (mg) of LY3473329 administered orally once daily (QD) over a 12-week treatment period. |
|
| 60 mg LY3473329 | Experimental | Participants received 60 mg of LY3473329 administered orally QD over a 12-week treatment period. |
|
| 240 mg LY3473329 | Experimental | Participants received 240 mg of LY3473329 administered orally QD over a 12-week treatment period. |
|
| Placebo | Placebo Comparator | Participants received a matching dose of placebo administered orally QD over a 12-week treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3473329 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Lp(a) - Assessed Via Intact Lp(a) Assay | Least Squares Mean (LS Mean) was calculated using a Mixed Model for Repeated Measures (MMRM): Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Treatment + Time + Treatment*Time. | Baseline, Week 12 |
| Percent Change From Baseline in Lp(a) - Assessed Via Apo(a) Assay | LS Mean was calculated using a MMRM: Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Treatment + Time + Treatment*Time. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Lp(a) < 125 Nmol/L - Assessed Via Intact Lp(a) Assay | The percentage of participants who achieved Lp(a) less than (<) 125 nmol/L, as measured using the intact Lp(a) assay, with data analysis performed through a logistic regression model that included imputed missing values, was reported. | Week 12 |
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Inclusion Criteria:
Participants must be at least 40 years old
Participants with Lp(a) ≥175 nmol/L at randomization, measured at the central laboratory.
High risk for cardiovascular events defined as documented coronary artery disease (CAD), stroke, or peripheral artery disease or atherosclerotic cardiovascular disease (ASCVD) risk equivalents (familial hypercholesterolemia or type 2 diabetes).
Participants on the following medications according to local practice must be on a stable regimen for at least 4 weeks prior to randomization and expected to remain on a stable regimen through the end of the post-treatment follow-up period.
Have a body mass index within the range 18.5 to 40 kilogram/square meter (kg/m²), inclusive.
Males who agree to use highly effective or effective methods of contraception may participate in this trial.
Women of childbearing potential (WOCBP) who agree to use highly effective or effective methods of contraception and women not of childbearing potential (WNOCBP) may participate in this trial.
Exclusion Criteria:
Have a history or presence of an underlying disease, or surgical, physical, medical, or psychiatric condition that, in the opinion of the investigator, would potentially affect participant safety within the study or interfere with participating in or completing the study or with the interpretation of data.
Any of the following, or other events indicating unstable medical condition in the opinion of the investigator, within 3 months of randomization:
Have, in the 6 months prior to day 1, uncontrolled Type 1 or Type 2 diabetes
Have uncontrolled hypertension
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Care Access - Baltimore | Baltimore | Maryland | 21213 | United States | ||
| Care Access - Dorchester |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39556768 | Derived | Nicholls SJ, Ni W, Rhodes GM, Nissen SE, Navar AM, Michael LF, Haupt A, Krege JH. Oral Muvalaplin for Lowering of Lipoprotein(a): A Randomized Clinical Trial. JAMA. 2025 Jan 21;333(3):222-231. doi: 10.1001/jama.2024.24017. | |
| 39329200 | Derived | Nicholls SJ, Nelson AJ, Michael LF. Oral agents for lowering lipoprotein(a). Curr Opin Lipidol. 2024 Dec 1;35(6):275-280. doi: 10.1097/MOL.0000000000000953. Epub 2024 Sep 25. |
| Label | URL |
|---|---|
| A Study of LY3473329 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events (KRAKEN) | View source |
Not provided
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | 10 mg LY3473329 | Participants received 10 milligrams (mg) of LY3473329 administered orally once daily (QD) over a 12-week treatment period. |
| FG001 | 60 mg LY3473329 | Participants received 60 mg of LY3473329 administered orally QD over a 12-week treatment period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 28, 2022 | Oct 22, 2024 |
Not provided
Not provided
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| Placebo | Drug | Administered orally |
|
| Percentage of Participants Who Achieved Lp(a) < 125 Nmol/L - Assessed Via Apo(a) Assay |
The percentage of participants who achieved Lp(a) < 125 nmol/L, as measured using the apo(a) assay, with data analysis performed through a logistic regression model that included imputed missing values, was reported. |
| Week 12 |
| Percent Change From Baseline in Apolipoprotein B (ApoB) | LS Mean was calculated using a MMRM: Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Baseline Lp(a) Stratum + Treatment + Time + Treatment*Time. | Baseline, Week 12 |
| Percent Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) | LS Mean was calculated using a MMRM: Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Baseline Lp(a) Stratum + Treatment + Time + Treatment*Time. | Baseline, Week 12 |
| Pharmacokinetics (PK): Trough Concentrations (C-trough) of LY3473329 | C-trough were measured at specified time points to assess the minimum concentration of LY3473329 in the blood before the next dose was administered. | Week from randomization 1, 2, 8, 12: Pre-dose |
| Dorchester |
| Massachusetts |
| 02124 |
| United States |
| Care Access - Lima | Lima | Ohio | 45805 | United States |
| Core Research Group | Brisbane | Queensland | 4064 | Australia |
| Nightingale Research | Adelaide | South Australia | 5000 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Victorian Heart Hospital | Clayton | Victoria | 3168 | Australia |
| CEDOES | Vitória | Espírito Santo | 29055450 | Brazil |
| Pesquisa Clínica em Diabetes - Dra Rosângela Réa | Curitiba | Paraná | 80040-110 | Brazil |
| Centro de Pesquisa Clinica do Coracao | Acaraju | Sergipe | 49055-530 | Brazil |
| Incor - Instituto do Coracao | São Paulo | São Paulo | 05403-900 | Brazil |
| IBPClin - Instituto Brasil de Pesquisa Clínica | Rio de Janeiro | 22241-180 | Brazil |
| CPCLIN | São Paulo | 01228-200 | Brazil |
| Instituto Dante Pazzanese de Cardiology | São Paulo | 04012-909 | Brazil |
| CEPIC - Centro Paulista de Investigação Clínica | São Paulo | 04266-010 | Brazil |
| Third People's Hospital of Hainan Province | Sanya | Hainan | 572000 | China |
| The First Hospital of Harbin Medical University | Harbin | Heilongjiang | 150001 | China |
| The Fourth Hospital of Harbin Medical University | Harbin | Heilongjiang | 150001 | China |
| Changzhou Second People's Hospital | Changzhou | Jiangsu | 213000 | China |
| The Second Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | 210011 | China |
| The Third Hospital of Nanchang | Nanchang | Jiangxi | 330009 | China |
| China-Japan Union Hospital | Changchun | Jilin | 130033 | China |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | 710061 | China |
| Gemeinschaftpraxis Dr. med. Martin Prohaska und Dr. med. Felix Schulte | Mühldorf | Bavaria | 84453 | Germany |
| ClinPhenomics GmbH & Co KG | Frankfurt am Main | Hesse | 60596 | Germany |
| Kath. St.-Johannes-Gesellschaft Dortmund | Dortmund | North Rhine-Westphalia | 44137 | Germany |
| Private Practice - Dr. Frank Menzel | Dessau | 06846 | Germany |
| Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ | Szeged | Csongrád megye | 6720 | Hungary |
| Medifarma 98 Kft | Nyíregyháza | Nyíregyháza | 4400 | Hungary |
| Flor Ferenc Hospital of Pest County | Kistarcsa | Pest County | 2143 | Hungary |
| Belvárosi Egészségház | Zalaegerszeg | Zala County | 8900 | Hungary |
| Dél-Pesti Centrumkórház | Budapest | 1097 | Hungary |
| Semmelweis University | Budapest | 1122 | Hungary |
| Funabashi Municipal Medical Center | Funabashi | Chiba | 273-0853 | Japan |
| Kokura Memorial Hospital | Kitakyushu | Fukuoka | 802-8555 | Japan |
| Iwate Prefectural Central Hospital | Morioka | Iwate | 020-0066 | Japan |
| Medical Corporation Heishinkai OCROM Clinic | Suita-shi | Osaka | 565-0853 | Japan |
| Minamino Cardiovascular Hospital | Hachiōji | Tokyo | 192-0918 | Japan |
| Hiroshima City Hospital | Hiroshima | 730-8518 | Japan |
| Miyazaki Medical Association Hospital | Miyazaki | 880-2102 | Japan |
| VieCuri Medisch Centrum, locatie Venlo | Venlo | Limburg | 5912 BL | Netherlands |
| Meander Medisch Centrum | Amersfoort | Utrecht | 3813 TZ | Netherlands |
| 38415744 | Derived | Karp A, Jacobs M, Barris B, Labkowsky A, Frishman WH. Lipoprotein(a): A Review of Risk Factors, Measurements, and Novel Treatment Modalities. Cardiol Rev. 2025 Jul-Aug 01;33(4):352-358. doi: 10.1097/CRD.0000000000000667. Epub 2024 Feb 28. |
| FG002 | 240 mg LY3473329 | Participants received 240 mg of LY3473329 administered orally QD over a 12-week treatment period. |
| FG003 | Placebo | Participants received a matching dose of placebo administered orally QD over a 12-week treatment period. |
| Received at Least One Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 10 mg LY3473329 | Participants received 10 mg of LY3473329 administered orally QD over a 12-week treatment period. |
| BG001 | 60 mg LY3473329 | Participants received 60 mg of LY3473329 administered orally QD over a 12-week treatment period. |
| BG002 | 240 mg LY3473329 | Participants received 240 mg of LY3473329 administered orally QD over a 12-week treatment period. |
| BG003 | Placebo | Participants received a matching dose of placebo administered orally QD over a 12-week treatment period. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| ||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| ||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| ||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
| ||||||||||
| Lp(a) - Assessed via Intact Lp(a) Assay | Lipoprotein(a) [Lp(a)] levels were assessed using an assay that measured intact Lp(a) particles, referred to as the "intact Lp(a) assay." | All randomized participants who had non-missing baseline Lp(a) data, as assessed by the intact Lp(a) assay. As pre-specified in the statistical analysis plan, intact Lp(a) assay measurements were not collected from participants at Chinese sites due to country-specific restrictions on sample storage. | Mean | Standard Deviation | nanomoles per liter (nmol/L) |
| ||||||||
| Lp(a) - Assessed via Apo(a) Assay | Lp(a) levels were assessed using an assay that measured total apolipoprotein(a) [apo(a)], referred to as the "apo(a) assay." | All randomized participants who had non-missing baseline Lp(a) data, as assessed by the apo(a) assay. | Mean | Standard Deviation | nanomoles per liter (nmol/L) |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change From Baseline in Lp(a) - Assessed Via Intact Lp(a) Assay | Least Squares Mean (LS Mean) was calculated using a Mixed Model for Repeated Measures (MMRM): Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Treatment + Time + Treatment*Time. | All randomized participants who received at least one dose of the study drug had a non-missing baseline value and at least one post-baseline value, as assessed by the intact Lp(a) assay, excluding data after discontinuation of the study drug or initiation of new Lp(a) modifying medication. As pre-specified in the statistical analysis plan, intact Lp(a) assay measurements were not collected from participants at Chinese sites due to country-specific restrictions on sample storage. | Posted | Least Squares Mean | Standard Error | Percent change | Baseline, Week 12 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percent Change From Baseline in Lp(a) - Assessed Via Apo(a) Assay | LS Mean was calculated using a MMRM: Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Treatment + Time + Treatment*Time. | All randomized participants who received at least one dose of the study drug, had a non-missing baseline value, and at least one post-baseline value, as assessed by the apo(a) assay, excluding data after discontinuation of the study drug or initiation of new Lp(a) modifying medication. | Posted | Least Squares Mean | Standard Error | Percent change | Baseline, Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved Lp(a) < 125 Nmol/L - Assessed Via Intact Lp(a) Assay | The percentage of participants who achieved Lp(a) less than (<) 125 nmol/L, as measured using the intact Lp(a) assay, with data analysis performed through a logistic regression model that included imputed missing values, was reported. | All randomized participants who received at least one dose of the study drug and had a non-missing baseline value, as assessed by the intact Lp(a) assay, excluding data after discontinuation of the study drug or initiation of new Lp(a) modifying medication. As pre-specified in the statistical analysis plan, intact Lp(a) assay measurements were not collected from participants at Chinese sites due to country-specific restrictions on sample storage. | Posted | Number | Percentage of participants | Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved Lp(a) < 125 Nmol/L - Assessed Via Apo(a) Assay | The percentage of participants who achieved Lp(a) < 125 nmol/L, as measured using the apo(a) assay, with data analysis performed through a logistic regression model that included imputed missing values, was reported. | All randomized participants who received at least one dose of the study drug and had a non-missing baseline value, as assessed by the apo(a) assay, excluding data after discontinuation of the study drug or initiation of new Lp(a) modifying medication. | Posted | Number | Percentage of participants | Week 12 |
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| Secondary | Percent Change From Baseline in Apolipoprotein B (ApoB) | LS Mean was calculated using a MMRM: Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Baseline Lp(a) Stratum + Treatment + Time + Treatment*Time. | All randomized participants who received at least one dose of the study drug and had a non-missing baseline value and at least one post-baseline value for this outcome, excluding data after discontinuation of the study drug or initiation of new Lp(a) modifying medication. | Posted | Least Squares Mean | Standard Error | Percent change | Baseline, Week 12 |
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| Secondary | Percent Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) | LS Mean was calculated using a MMRM: Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Baseline Lp(a) Stratum + Treatment + Time + Treatment*Time. | All randomized participants who received at least one dose of the study drug and had a non-missing baseline value and at least one post-baseline value for this outcome, excluding data after discontinuation of the study drug or initiation of new Lp(a) modifying medication. | Posted | Least Squares Mean | Standard Error | Percent change | Baseline, Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK): Trough Concentrations (C-trough) of LY3473329 | C-trough were measured at specified time points to assess the minimum concentration of LY3473329 in the blood before the next dose was administered. | All randomized participants who received at least one dose of the study drug and had evaluable PK samples for the relevant weeks were included in this outcome analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Week from randomization 1, 2, 8, 12: Pre-dose |
|
|
Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 10 mg LY3473329 | Participants received 10 mg of LY3473329 administered orally QD over a 12-week treatment period. | 0 | 34 | 2 | 34 | 7 | 34 |
| EG001 | 60 mg LY3473329 | Participants received 60 mg of LY3473329 administered orally QD over a 12-week treatment period. | 0 | 63 | 2 | 63 | 5 | 63 |
| EG002 | 240 mg LY3473329 | Participants received 240 mg of LY3473329 administered orally QD over a 12-week treatment period. | 0 | 68 | 2 | 68 | 10 | 68 |
| EG003 | Placebo | Participants received a matching dose of placebo administered orally QD over a 12-week treatment period. | 0 | 67 | 4 | 67 | 11 | 67 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Priapism | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Peripheral vascular haematoma | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
|
Due to country-specific restrictions on sample storage, measurements for the primary endpoint and key secondary endpoints involving Lp(a), as assessed by the intact Lp(a) assay, could not be obtained from participants at the Chinese sites. As a result, intact Lp(a) assay outcome data from these sites were not reported.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 20, 2023 | Oct 22, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D050171 | Dyslipidemias |
| D002318 | Cardiovascular Diseases |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
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|
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| Brazil |
|
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| China |
|
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| Germany |
|
|
| Hungary |
|
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| Japan |
|
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| Netherlands |
|
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| United States |
|
|
|
|
| LS Mean Difference (Final Values) |
| -81.66 |
| 2-Sided |
| 95 |
| -84.62 |
| -78.13 |
| Superiority |
| Mixed Models Analysis | <.001 | LS Mean Difference (Final Values) | -85.77 | 2-Sided | 95 | -88.03 | -83.09 | Superiority |
Participants received a matching dose of placebo administered orally QD over a 12-week treatment period.
|
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| OG003 | Placebo | Participants received a matching dose of placebo administered orally QD over a 12-week treatment period. |
|
|
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Participants received a matching dose of placebo administered orally QD over a 12-week treatment period. |
|
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Participants received a matching dose of placebo administered orally QD over a 12-week treatment period.
|
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Participants received a matching dose of placebo administered orally QD over a 12-week treatment period.
|
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| Participants |
|
|