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| ID | Type | Description | Link |
|---|---|---|---|
| MK-0616-018 | Other Identifier | MSD | |
| 2023-504920-25-00 | Registry Identifier | EU CT | |
| U1111-1290-3888 | Registry Identifier | UTN |
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The main purpose of this study is to assess whether enlicitide is superior to ezetimibe or bempedoic acid or ezetimibe + bempedoic acid in reducing low-density lipoprotein cholesterol (LDL-C) in participants with hypercholesterolemia, and to evaluate its safety and tolerability. The primary study hypotheses are enlicitide is superior to ezetimibe, bempedoic acid, and ezetimibe + bempedoic acid on mean percent change from baseline in LDL-C at week 8.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enlicitide | Experimental | Participants receive enlicitide 20mg, ezetimibe-matching placebo, and bempedoic acid-matching placebo once daily (QD) orally up to approximately 56 days. |
|
| Ezetimibe | Active Comparator | Participants receive ezetimibe 10mg, enlicitide-matching placebo, and bempedoic acid-matching placebo QD orally up to approximately 56 days. |
|
| Bempedoic Acid | Active Comparator | Participants receive bempedoic acid 180mg, ezetimibe-matching placebo, and enlicitide-matching placebo QD orally up to approximately 56 days. |
|
| Ezetimibe + Bempedoic Acid | Active Comparator | Participants receive ezetimibe 10 mg, bempedoic acid 180mg, enlicitide-matching placebo orally QD for approximately 56 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enlicitide | Drug | Oral tablet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 56 | Blood samples were collected at baseline and after 56 days of treatment to assess mean percentage change in LDL-C. The mean percent change from baseline in LDL-C at Day-56 is reported. | Baseline and Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change From Baseline in Apolipoprotein B (ApoB) at Day 56 | Blood samples were collected at baseline and on day 56 of treatment to assess mean percent change in ApoB. The mean percent change from baseline in ApoB at Day 56 is reported. | Baseline and Day 56 |
| Mean Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Day 56 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trials Research ( Site 1509) | Lincoln | California | 95648 | United States | ||
| Healthcare Research Network - Chicago ( Site 1507) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42017875 | Derived | Catapano AL, Mikhailova E, Navar AM, Banka P, Corral P, Saxena M, Steg PG, Verma S, Kordahi AY, Mendizabal G, Zhu P, Ballantyne CM; CORALreef AddOn Investigators. Oral PCSK9 Inhibitor Enlicitide Versus Oral Nonstatin Therapies: A Phase 3 Randomized Clinical Trial. J Am Coll Cardiol. 2026 Mar 30:S0735-1097(26)05832-8. doi: 10.1016/j.jacc.2026.03.036. Online ahead of print. |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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301 participants were randomized in 2:1:1:2 ratio to receive enlicitide, ezetimibe, bempedoic acid, or ezetimibe + bempedoic acid.
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| ID | Title | Description |
|---|---|---|
| FG000 | Enlicitide | Participants receive enlicitide 20mg, ezetimibe-matching placebo, and bempedoic acid-matching placebo once daily (QD) orally up to approximately 56 days. |
| FG001 | Bempedoic Acid |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 17, 2024 |
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| Ezetimibe | Drug | Oral tablet |
|
| Bempedoic Acid | Drug | Oral capsule |
|
| Placebo for Enlicitide | Other | enlicitide-matching placebo oral tablet |
|
| Placebo for Ezetimibe | Other | ezetimibe-matching placebo oral tablet |
|
| Placebo for Bempedoic Acid | Other | bempedoic acid-matching placebo oral capsule |
|
Blood samples were collected at baseline and on day 56 of treatment to assess mean percent change in non-HDL-C. The mean percent change from baseline in non-HDL-C at 56 days is reported. |
| Baseline and Day 56 |
| Median Percent Change From Baseline in Lipoprotein(a) Levels (Lp[a]) | Blood samples were collected at baseline and on day 56 of treatment to assess median percent change in Lp(a) levels. The median percent change from baseline at Day 56 is reported. | Baseline and Day 56 |
| Percentage of Participants Who at Day 56 Have an LDL-C <70 mg/dL and ≥50% Reduction From Baseline | Blood samples were collected at baseline and after 56 days of treatment to assess the percentage of participants who have an LDL-C <70 mg/dL and ≥50% reduction from baseline at day 56. The percentage of participants who have LDL-C <70 mg/dL and ≥50% reduction from baseline is reported. | Baseline and Day 56 |
| Percentage of Participants Who at Day 56 Have an LDL-C <55 mg/dL and ≥50% Reduction From Baseline | Blood samples were collected at baseline and after 56 days of treatment to assess the percentage of participants who have an LDL-C <55 mg/dL and ≥50% reduction from baseline at day 56. The percentage of participants who have LDL-C <55 mg/dL and ≥50% reduction from baseline is reported. | Baseline and Day 56 |
| Percentage of Participants With ≥1 Adverse Event (AE) | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced an AE is reported. | Up to approximately 147 days |
| Percentage of Participants Discontinuing From Study Intervention Due to AE | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinued study intervention due to an AE is reported. | Up to approximately 91 days |
| Flossmoor |
| Illinois |
| 60422 |
| United States |
| L-MARC Research Center ( Site 1501) | Louisville | Kentucky | 40213 | United States |
| Velocity Clinical Research Rockville ( Site 1503) | Rockville | Maryland | 20854 | United States |
| Velocity Clinical Research, Gulfport ( Site 1505) | Gulfport | Mississippi | 39503 | United States |
| Piedmont Research Partners ( Site 1506) | Fort Mill | South Carolina | 29707 | United States |
| Rainier Clinical Research Center ( Site 1502) | Renton | Washington | 98057 | United States |
| Instituto de Investigaciones ClÃnicas Mar del Plata ( Site 1002) | Mar del Plata | Buenos Aires | B7600FZO | Argentina |
| CIPREC-CIPREC Sede Arenales ( Site 1000) | Buenos Aires | Buenos Aires F.D. | C1061AAS | Argentina |
| Fundacion Estudios Clinicos ( Site 1001) | Rosario | Santa Fe Province | S2000DEJ | Argentina |
| The Medical Arts Health Research Group ( Site 1606) | Vancouver | British Columbia | V7M 2H4 | Canada |
| Cambridge Cardiac Care Centre ( Site 1603) | Cambridge | Ontario | N1R 6V6 | Canada |
| North York Diagnostic and Cardiac Centre ( Site 1605) | North York | Ontario | M6B 3H7 | Canada |
| Institut de Cardiologie de Montreal ( Site 1604) | Montreal | Quebec | H1T 1C8 | Canada |
| Diex Recherche Trois-Rivieres ( Site 1602) | Trois-Rivières | Quebec | G9A 4P3 | Canada |
| Hôpital Arnaud de Villeneuve - CHU Montpellier ( Site 0505) | Montpellier | Herault | 34090 | France |
| Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes-CIC Endocrinology-Diabetology-Nutrition ( Sit | Nantes | Loire-Atlantique | 44093 | France |
| Hospices Civils de Lyon - Hopital Louis Pradel ( Site 0501) | Bron | Rhone | 69677 | France |
| Hôpital Bichat - Claude-Bernard ( Site 0504) | Paris | 75018 | France |
| Yitzhak Shamir Medical Center. ( Site 0702) | Beer Yaakov | 70300 | Israel |
| Assuta Beersheba MC ( Site 0704) | Beersheba | 8489507 | Israel |
| Rambam Health Care Campus ( Site 0700) | Haifa | 3109601 | Israel |
| Meir Medical Center. ( Site 0703) | Kfar Saba | 4428164 | Israel |
| Hospital Universitario Virgen de la Victoria-UGC Endocrinologia y nutricion ( Site 0801) | Málaga | Andalusia | 29010 | Spain |
| Hospital de Figueres ( Site 0804) | Figueres | Gerona | 17600 | Spain |
| Hospital San Rafael de Coruna ( Site 0805) | A Coruña | La Coruna | 15006 | Spain |
| EAP Sardenya ( Site 0800) | Barcelona | 08025 | Spain |
| Hospital Universitari Vall d'Hebron ( Site 0803) | Barcelona | 08035 | Spain |
| National Cheng Kung University Hospital-Internal Medicine ( Site 0403) | Tainan | 704 | Taiwan |
| National Taiwan University Hospital ( Site 0400) | Taipei | 10002 | Taiwan |
| Taipei Veterans General Hospital-Department of Medicine ( Site 0402) | Taipei | 11217 | Taiwan |
| Chang Gung Medical Foundation-Linkou Branch ( Site 0404) | Taoyuan | 33305 | Taiwan |
| Barts Health NHS Trust-William Harvey Clinical Research Centre ( Site 0901) | London | England | EC1M 6BQ | United Kingdom |
| Royal Free Hospital ( Site 0900) | London | England | NW3 2QG | United Kingdom |
| National Institute for Health Research UCLH Clinical Research Facility ( Site 0908) | London | London, City of | NW1 2PG | United Kingdom |
| Plain Language Summary | View source |
Participants receive bempedoic acid 180mg, ezetimibe-matching placebo, and enlicitide-matching placebo QD orally up to approximately 56 days.
| FG002 | Ezetimibe | Participants receive ezetimibe 10mg, enlicitide-matching placebo, and bempedoic acid-matching placebo QD orally up to approximately 56 days. |
| FG003 | Ezetimibe + Bempedoic Acid | Participants receive ezetimibe 10 mg, bempedoic acid 180mg, enlicitide-matching placebo orally QD for approximately 56 days. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Enlicitide | Participants receive enlicitide 20mg, ezetimibe-matching placebo, and bempedoic acid-matching placebo once daily (QD) orally up to approximately 56 days. |
| BG001 | Bempedoic Acid | Participants receive bempedoic acid 180mg, ezetimibe-matching placebo, and enlicitide-matching placebo QD orally up to approximately 56 days. |
| BG002 | Ezetimibe | Participants receive ezetimibe 10mg, enlicitide-matching placebo, and bempedoic acid-matching placebo QD orally up to approximately 56 days. |
| BG003 | Ezetimibe + Bempedoic Acid | Participants receive ezetimibe 10 mg, bempedoic acid 180mg, enlicitide-matching placebo orally QD for approximately 56 days. |
| 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Renal Function measured by estimated Glomerular Filtration Rate (eGFR) | Stratification by renal function was used to support balanced randomization of participants with eGFR values ≥60 or <60 mL/min/1.73 m^2 at Visit 1 (Screening) across the 4 treatment groups. Renal function (eGFR) was grouped into three categories: ≥35 to <45 mL/min/1.73 m^2 ; ≥45 to <60 mL/min/1.73 m^2 ; and ≥60 mL/min/1.73 m^2. Number of participants in each category is reported. | Count of Participants | Participants |
| |||||||||||||||
| Mean low-density lipoprotein cholesterol (LDL-C) at Baseline | Blood samples were collected at baseline to assess mean LDL-C for each arm. | Mean | Standard Deviation | mg/dL |
|
| 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 | Mean Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 56 | Blood samples were collected at baseline and after 56 days of treatment to assess mean percentage change in LDL-C. The mean percent change from baseline in LDL-C at Day-56 is reported. | All participants who received at least 1 dose of study intervention. | Posted | Mean | 95% Confidence Interval | Percent Change | Baseline and Day 56 |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Percent Change From Baseline in Apolipoprotein B (ApoB) at Day 56 | Blood samples were collected at baseline and on day 56 of treatment to assess mean percent change in ApoB. The mean percent change from baseline in ApoB at Day 56 is reported. | All participants who received at least 1 dose of study intervention. | Posted | Mean | 95% Confidence Interval | Percent Change | Baseline and Day 56 |
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| Secondary | Mean Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Day 56 | Blood samples were collected at baseline and on day 56 of treatment to assess mean percent change in non-HDL-C. The mean percent change from baseline in non-HDL-C at 56 days is reported. | All participants who received at least 1 dose of study intervention. | Posted | Mean | 95% Confidence Interval | Percent Change | Baseline and Day 56 |
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| Secondary | Median Percent Change From Baseline in Lipoprotein(a) Levels (Lp[a]) | Blood samples were collected at baseline and on day 56 of treatment to assess median percent change in Lp(a) levels. The median percent change from baseline at Day 56 is reported. | All participants who received at least 1 dose of study intervention. | Posted | Median | Full Range | Percent Change | Baseline and Day 56 |
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| Secondary | Percentage of Participants Who at Day 56 Have an LDL-C <70 mg/dL and ≥50% Reduction From Baseline | Blood samples were collected at baseline and after 56 days of treatment to assess the percentage of participants who have an LDL-C <70 mg/dL and ≥50% reduction from baseline at day 56. The percentage of participants who have LDL-C <70 mg/dL and ≥50% reduction from baseline is reported. | All participants who received at least 1 dose of study intervention. | Posted | Number | Percentage of Participants | Baseline and Day 56 |
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| Secondary | Percentage of Participants Who at Day 56 Have an LDL-C <55 mg/dL and ≥50% Reduction From Baseline | Blood samples were collected at baseline and after 56 days of treatment to assess the percentage of participants who have an LDL-C <55 mg/dL and ≥50% reduction from baseline at day 56. The percentage of participants who have LDL-C <55 mg/dL and ≥50% reduction from baseline is reported. | All participants who received at least 1 dose of study intervention. | Posted | Number | Percentage of participants | Baseline and Day 56 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With ≥1 Adverse Event (AE) | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced an AE is reported. | All participants who received at least 1 dose of study intervention. | Posted | Number | Percentage of Participants | Up to approximately 147 days |
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| Secondary | Percentage of Participants Discontinuing From Study Intervention Due to AE | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinued study intervention due to an AE is reported. | All participants who received at least 1 dose of study intervention. | Posted | Number | Percentage of participants | Up to approximately 91 days |
|
Death and adverse events up to 147 Days.
All-Cause Mortality includes all randomized participants. Serious Adverse Events and Other Adverse Events includes all participants who received at least one dose of study intervention.
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 | Enlicitide 20 mg | Participants receive enlicitide 20mg, ezetimibe-matching placebo, and bempedoic acid-matching placebo once daily (QD) orally up to approximately 56 days. | 0 | 101 | 0 | 101 | 0 | 101 |
| EG001 | Bempedoic Acid 180 mg | Participants receive bempedoic acid 180mg, ezetimibe-matching placebo, and enlicitide-matching placebo QD orally up to approximately 56 days. | 0 | 50 | 4 | 50 | 3 | 50 |
| EG002 | Ezetimibe 10 mg | Participants receive ezetimibe 10mg, enlicitide-matching placebo, and bempedoic acid-matching placebo QD orally up to approximately 56 days. | 0 | 50 | 1 | 50 | 3 | 50 |
| EG003 | Ezetimibe 10 mg and Bempedoic Acid 180 mg | Participants receive ezetimibe 10 mg, bempedoic acid 180mg, enlicitide-matching placebo orally QD for approximately 56 days. | 0 | 100 | 0 | 100 | 0 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Mental disorder | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
|
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors (ICMJE) authorship requirements.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
| Feb 11, 2026 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000728674 | MK-0616 |
| D000069438 | Ezetimibe |
| C581236 | 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| ≥45 to <60 |
|
| ≥60 |
|
| ANCOVA |
| <0.001 |
| Difference in Means |
| -36.0 |
| 2-Sided |
| 95 |
| -41.8 |
| -30.2 |
Difference in LS means between treatment groups (Enlicitide 20 mg - Ezetimibe 10 mg) is estimated based on the washout and bootstrap imputation method through the ANCOVA model with treatment as a fixed effect and baseline as a covariate. |
| Superiority |
Enlicitide 20 mg vs Ezetimibe 10 mg |
| ANCOVA | <0.001 | Difference in Means | -28.1 | 2-Sided | 95 | -33.6 | -22.6 | Difference in LS means between treatment groups (Enlicitide 20 mg - Ezetimibe 10 mg and Bempedoic acid 180 mg) is estimated based on the W&B imputation method through the ANCOVA model with treatment as a fixed effect and baseline as a covariate. | Superiority | Enlicitide 20 mg vs Ezetimibe 10 mg + Bempedoic Acid 180 mg |
Participants receive ezetimibe 10 mg, bempedoic acid 180mg, enlicitide-matching placebo orally QD for approximately 56 days.
|
|
|
Participants receive ezetimibe 10 mg, bempedoic acid 180mg, enlicitide-matching placebo orally QD for approximately 56 days.
|
|
|
|
|
| Ezetimibe + Bempedoic Acid |
Participants receive ezetimibe 10 mg, bempedoic acid 180mg, enlicitide-matching placebo orally QD for approximately 56 days. |
|
|
| Ezetimibe + Bempedoic Acid |
Participants receive ezetimibe 10 mg, bempedoic acid 180mg, enlicitide-matching placebo orally QD for approximately 56 days. |
|
|
| OG003 | Ezetimibe + Bempedoic Acid | Participants receive ezetimibe 10 mg, bempedoic acid 180mg, enlicitide-matching placebo orally QD for approximately 56 days. |
|
|
| OG003 | Ezetimibe + Bempedoic Acid | Participants receive ezetimibe 10 mg, bempedoic acid 180mg, enlicitide-matching placebo orally QD for approximately 56 days. |
|
|