Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Enlicitide (MK-0616, Oral PCSK9 Inhibitor) Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia (MK-0616-018/CORALreef AddOn) (NCT NCT06450366)
NCT ID: NCT06450366
Last Updated: 2026-03-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
301 participants
Primary outcome timeframe
Baseline and Day 56
Results posted on
2026-03-27
Participant Flow
301 participants were randomized in 2:1:1:2 ratio to receive enlicitide, ezetimibe, bempedoic acid, or ezetimibe + bempedoic acid.
Participant milestones
| Measure |
Enlicitide
Participants receive enlicitide 20mg, ezetimibe-matching placebo, and bempedoic acid-matching placebo once daily (QD) orally up to approximately 56 days.
|
Bempedoic Acid
Participants receive bempedoic acid 180mg, ezetimibe-matching placebo, and enlicitide-matching placebo QD orally up to approximately 56 days.
|
Ezetimibe
Participants receive ezetimibe 10mg, enlicitide-matching placebo, and bempedoic acid-matching placebo QD orally up to approximately 56 days.
|
Ezetimibe + Bempedoic Acid
Participants receive ezetimibe 10 mg, bempedoic acid 180mg, enlicitide-matching placebo orally QD for approximately 56 days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
101
|
50
|
50
|
100
|
|
Overall Study
COMPLETED
|
100
|
48
|
50
|
100
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
Enlicitide
Participants receive enlicitide 20mg, ezetimibe-matching placebo, and bempedoic acid-matching placebo once daily (QD) orally up to approximately 56 days.
|
Bempedoic Acid
Participants receive bempedoic acid 180mg, ezetimibe-matching placebo, and enlicitide-matching placebo QD orally up to approximately 56 days.
|
Ezetimibe
Participants receive ezetimibe 10mg, enlicitide-matching placebo, and bempedoic acid-matching placebo QD orally up to approximately 56 days.
|
Ezetimibe + Bempedoic Acid
Participants receive ezetimibe 10 mg, bempedoic acid 180mg, enlicitide-matching placebo orally QD for approximately 56 days.
|
|---|---|---|---|---|
|
Overall Study
Participant Moved
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Enlicitide (MK-0616, Oral PCSK9 Inhibitor) Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia (MK-0616-018/CORALreef AddOn)
Baseline characteristics by cohort
| Measure |
Enlicitide
n=101 Participants
Participants receive enlicitide 20mg, ezetimibe-matching placebo, and bempedoic acid-matching placebo once daily (QD) orally up to approximately 56 days.
|
Bempedoic Acid
n=50 Participants
Participants receive bempedoic acid 180mg, ezetimibe-matching placebo, and enlicitide-matching placebo QD orally up to approximately 56 days.
|
Ezetimibe
n=50 Participants
Participants receive ezetimibe 10mg, enlicitide-matching placebo, and bempedoic acid-matching placebo QD orally up to approximately 56 days.
|
Ezetimibe + Bempedoic Acid
n=100 Participants
Participants receive ezetimibe 10 mg, bempedoic acid 180mg, enlicitide-matching placebo orally QD for approximately 56 days.
|
Total
n=301 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
64.3 Years
STANDARD_DEVIATION 9.7 • n=56 Participants
|
65.4 Years
STANDARD_DEVIATION 10.2 • n=62 Participants
|
65.4 Years
STANDARD_DEVIATION 9.3 • n=123 Participants
|
63.5 Years
STANDARD_DEVIATION 10.9 • n=53 Participants
|
64.4 Years
STANDARD_DEVIATION 10.1 • n=654 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=56 Participants
|
18 Participants
n=62 Participants
|
18 Participants
n=123 Participants
|
37 Participants
n=53 Participants
|
112 Participants
n=654 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=56 Participants
|
32 Participants
n=62 Participants
|
32 Participants
n=123 Participants
|
63 Participants
n=53 Participants
|
189 Participants
n=654 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=56 Participants
|
12 Participants
n=62 Participants
|
18 Participants
n=123 Participants
|
28 Participants
n=53 Participants
|
83 Participants
n=654 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
74 Participants
n=56 Participants
|
38 Participants
n=62 Participants
|
32 Participants
n=123 Participants
|
72 Participants
n=53 Participants
|
216 Participants
n=654 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
2 Participants
n=654 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
|
Race (NIH/OMB)
Asian
|
26 Participants
n=56 Participants
|
16 Participants
n=62 Participants
|
14 Participants
n=123 Participants
|
24 Participants
n=53 Participants
|
80 Participants
n=654 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=56 Participants
|
5 Participants
n=62 Participants
|
3 Participants
n=123 Participants
|
5 Participants
n=53 Participants
|
21 Participants
n=654 Participants
|
|
Race (NIH/OMB)
White
|
66 Participants
n=56 Participants
|
29 Participants
n=62 Participants
|
33 Participants
n=123 Participants
|
70 Participants
n=53 Participants
|
198 Participants
n=654 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
1 Participants
n=53 Participants
|
1 Participants
n=654 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
1 Participants
n=654 Participants
|
|
Renal Function measured by estimated Glomerular Filtration Rate (eGFR)
≥35 to <45
|
2 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
2 Participants
n=123 Participants
|
1 Participants
n=53 Participants
|
5 Participants
n=654 Participants
|
|
Renal Function measured by estimated Glomerular Filtration Rate (eGFR)
≥45 to <60
|
9 Participants
n=56 Participants
|
4 Participants
n=62 Participants
|
3 Participants
n=123 Participants
|
7 Participants
n=53 Participants
|
23 Participants
n=654 Participants
|
|
Renal Function measured by estimated Glomerular Filtration Rate (eGFR)
≥60
|
90 Participants
n=56 Participants
|
46 Participants
n=62 Participants
|
45 Participants
n=123 Participants
|
92 Participants
n=53 Participants
|
273 Participants
n=654 Participants
|
|
Mean low-density lipoprotein cholesterol (LDL-C) at Baseline
|
89.9 mg/dL
STANDARD_DEVIATION 31.4 • n=56 Participants
|
91.9 mg/dL
STANDARD_DEVIATION 24.4 • n=62 Participants
|
93.2 mg/dL
STANDARD_DEVIATION 27.4 • n=123 Participants
|
92.6 mg/dL
STANDARD_DEVIATION 33.4 • n=53 Participants
|
91.6 mg/dL
STANDARD_DEVIATION 30.3 • n=654 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 56Population: All participants who received at least 1 dose of study intervention.
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.
Outcome measures
| Measure |
Ezetimibe + Bempedoic Acid
n=100 Participants
Participants receive ezetimibe 10 mg, bempedoic acid 180mg, enlicitide-matching placebo orally QD for approximately 56 days.
|
Enlicitide
n=101 Participants
Participants receive enlicitide 20mg, ezetimibe-matching placebo, and bempedoic acid-matching placebo once daily (QD) orally up to approximately 56 days.
|
Bempedoic Acid
n=50 Participants
Participants receive bempedoic acid 180mg, ezetimibe-matching placebo, and enlicitide-matching placebo QD orally up to approximately 56 days.
|
Ezetimibe
n=50 Participants
Participants receive ezetimibe 10mg, enlicitide-matching placebo, and bempedoic acid-matching placebo QD orally up to approximately 56 days.
|
|---|---|---|---|---|
|
Mean Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 56
|
-36.5 Percent Change
Interval -40.8 to -32.2
|
-64.6 Percent Change
Interval -68.3 to -60.9
|
-6.3 Percent Change
Interval -13.5 to 0.8
|
-27.8 Percent Change
Interval -32.3 to -23.4
|
SECONDARY outcome
Timeframe: Baseline and Day 56Population: All participants who received at least 1 dose of study intervention.
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.
Outcome measures
| Measure |
Ezetimibe + Bempedoic Acid
n=100 Participants
Participants receive ezetimibe 10 mg, bempedoic acid 180mg, enlicitide-matching placebo orally QD for approximately 56 days.
|
Enlicitide
n=101 Participants
Participants receive enlicitide 20mg, ezetimibe-matching placebo, and bempedoic acid-matching placebo once daily (QD) orally up to approximately 56 days.
|
Bempedoic Acid
n=50 Participants
Participants receive bempedoic acid 180mg, ezetimibe-matching placebo, and enlicitide-matching placebo QD orally up to approximately 56 days.
|
Ezetimibe
n=50 Participants
Participants receive ezetimibe 10mg, enlicitide-matching placebo, and bempedoic acid-matching placebo QD orally up to approximately 56 days.
|
|---|---|---|---|---|
|
Mean Percent Change From Baseline in Apolipoprotein B (ApoB) at Day 56
|
-27.7 Percent Change
Interval -31.1 to -24.3
|
-54.6 Percent Change
Interval -57.6 to -51.6
|
-5.4 Percent Change
Interval -10.3 to -0.5
|
-20.2 Percent Change
Interval -23.3 to -17.2
|
SECONDARY outcome
Timeframe: Baseline and Day 56Population: All participants who received at least 1 dose of study intervention.
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.
Outcome measures
| Measure |
Ezetimibe + Bempedoic Acid
n=100 Participants
Participants receive ezetimibe 10 mg, bempedoic acid 180mg, enlicitide-matching placebo orally QD for approximately 56 days.
|
Enlicitide
n=101 Participants
Participants receive enlicitide 20mg, ezetimibe-matching placebo, and bempedoic acid-matching placebo once daily (QD) orally up to approximately 56 days.
|
Bempedoic Acid
n=50 Participants
Participants receive bempedoic acid 180mg, ezetimibe-matching placebo, and enlicitide-matching placebo QD orally up to approximately 56 days.
|
Ezetimibe
n=50 Participants
Participants receive ezetimibe 10mg, enlicitide-matching placebo, and bempedoic acid-matching placebo QD orally up to approximately 56 days.
|
|---|---|---|---|---|
|
Mean Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Day 56
|
-31.8 Percent Change
Interval -35.8 to -27.9
|
-58.0 Percent Change
Interval -61.3 to -54.7
|
-5.2 Percent Change
Interval -11.5 to 1.1
|
-25.1 Percent Change
Interval -28.7 to -21.6
|
SECONDARY outcome
Timeframe: Baseline and Day 56Population: All participants who received at least 1 dose of study intervention.
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.
Outcome measures
| Measure |
Ezetimibe + Bempedoic Acid
n=100 Participants
Participants receive ezetimibe 10 mg, bempedoic acid 180mg, enlicitide-matching placebo orally QD for approximately 56 days.
|
Enlicitide
n=101 Participants
Participants receive enlicitide 20mg, ezetimibe-matching placebo, and bempedoic acid-matching placebo once daily (QD) orally up to approximately 56 days.
|
Bempedoic Acid
n=50 Participants
Participants receive bempedoic acid 180mg, ezetimibe-matching placebo, and enlicitide-matching placebo QD orally up to approximately 56 days.
|
Ezetimibe
n=50 Participants
Participants receive ezetimibe 10mg, enlicitide-matching placebo, and bempedoic acid-matching placebo QD orally up to approximately 56 days.
|
|---|---|---|---|---|
|
Median Percent Change From Baseline in Lipoprotein(a) Levels (Lp[a])
|
10.4 Percent Change
Interval -50.5 to 321.8
|
-26.2 Percent Change
Interval -84.4 to 12.7
|
8.1 Percent Change
Interval -94.2 to 103.3
|
0.0 Percent Change
Interval -27.4 to 47.0
|
SECONDARY outcome
Timeframe: Baseline and Day 56Population: All participants who received at least 1 dose of study intervention.
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.
Outcome measures
| Measure |
Ezetimibe + Bempedoic Acid
n=100 Participants
Participants receive ezetimibe 10 mg, bempedoic acid 180mg, enlicitide-matching placebo orally QD for approximately 56 days.
|
Enlicitide
n=101 Participants
Participants receive enlicitide 20mg, ezetimibe-matching placebo, and bempedoic acid-matching placebo once daily (QD) orally up to approximately 56 days.
|
Bempedoic Acid
n=50 Participants
Participants receive bempedoic acid 180mg, ezetimibe-matching placebo, and enlicitide-matching placebo QD orally up to approximately 56 days.
|
Ezetimibe
n=50 Participants
Participants receive ezetimibe 10mg, enlicitide-matching placebo, and bempedoic acid-matching placebo QD orally up to approximately 56 days.
|
|---|---|---|---|---|
|
Percentage of Participants Who at Day 56 Have an LDL-C <70 mg/dL and ≥50% Reduction From Baseline
|
22.0 Percentage of Participants
|
81.2 Percentage of Participants
|
2.0 Percentage of Participants
|
8.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and Day 56Population: All participants who received at least 1 dose of study intervention.
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.
Outcome measures
| Measure |
Ezetimibe + Bempedoic Acid
n=100 Participants
Participants receive ezetimibe 10 mg, bempedoic acid 180mg, enlicitide-matching placebo orally QD for approximately 56 days.
|
Enlicitide
n=101 Participants
Participants receive enlicitide 20mg, ezetimibe-matching placebo, and bempedoic acid-matching placebo once daily (QD) orally up to approximately 56 days.
|
Bempedoic Acid
n=50 Participants
Participants receive bempedoic acid 180mg, ezetimibe-matching placebo, and enlicitide-matching placebo QD orally up to approximately 56 days.
|
Ezetimibe
n=50 Participants
Participants receive ezetimibe 10mg, enlicitide-matching placebo, and bempedoic acid-matching placebo QD orally up to approximately 56 days.
|
|---|---|---|---|---|
|
Percentage of Participants Who at Day 56 Have an LDL-C <55 mg/dL and ≥50% Reduction From Baseline
|
20.0 Percentage of participants
|
78.2 Percentage of participants
|
2.0 Percentage of participants
|
8.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to approximately 147 daysPopulation: All participants who received at least 1 dose of study intervention.
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.
Outcome measures
| Measure |
Ezetimibe + Bempedoic Acid
n=100 Participants
Participants receive ezetimibe 10 mg, bempedoic acid 180mg, enlicitide-matching placebo orally QD for approximately 56 days.
|
Enlicitide
n=101 Participants
Participants receive enlicitide 20mg, ezetimibe-matching placebo, and bempedoic acid-matching placebo once daily (QD) orally up to approximately 56 days.
|
Bempedoic Acid
n=50 Participants
Participants receive bempedoic acid 180mg, ezetimibe-matching placebo, and enlicitide-matching placebo QD orally up to approximately 56 days.
|
Ezetimibe
n=50 Participants
Participants receive ezetimibe 10mg, enlicitide-matching placebo, and bempedoic acid-matching placebo QD orally up to approximately 56 days.
|
|---|---|---|---|---|
|
Percentage of Participants With ≥1 Adverse Event (AE)
|
45.0 Percentage of Participants
|
39.6 Percentage of Participants
|
38.0 Percentage of Participants
|
36.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to approximately 91 daysPopulation: All participants who received at least 1 dose of study intervention.
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.
Outcome measures
| Measure |
Ezetimibe + Bempedoic Acid
n=100 Participants
Participants receive ezetimibe 10 mg, bempedoic acid 180mg, enlicitide-matching placebo orally QD for approximately 56 days.
|
Enlicitide
n=101 Participants
Participants receive enlicitide 20mg, ezetimibe-matching placebo, and bempedoic acid-matching placebo once daily (QD) orally up to approximately 56 days.
|
Bempedoic Acid
n=50 Participants
Participants receive bempedoic acid 180mg, ezetimibe-matching placebo, and enlicitide-matching placebo QD orally up to approximately 56 days.
|
Ezetimibe
n=50 Participants
Participants receive ezetimibe 10mg, enlicitide-matching placebo, and bempedoic acid-matching placebo QD orally up to approximately 56 days.
|
|---|---|---|---|---|
|
Percentage of Participants Discontinuing From Study Intervention Due to AE
|
4.0 Percentage of participants
|
2.0 Percentage of participants
|
4.0 Percentage of participants
|
0.0 Percentage of participants
|
Adverse Events
Enlicitide 20 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bempedoic Acid 180 mg
Serious events: 4 serious events
Other events: 3 other events
Deaths: 0 deaths
Ezetimibe 10 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Ezetimibe 10 mg and Bempedoic Acid 180 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Enlicitide 20 mg
n=101 participants at risk
Participants receive enlicitide 20mg, ezetimibe-matching placebo, and bempedoic acid-matching placebo once daily (QD) orally up to approximately 56 days.
|
Bempedoic Acid 180 mg
n=50 participants at risk
Participants receive bempedoic acid 180mg, ezetimibe-matching placebo, and enlicitide-matching placebo QD orally up to approximately 56 days.
|
Ezetimibe 10 mg
n=50 participants at risk
Participants receive ezetimibe 10mg, enlicitide-matching placebo, and bempedoic acid-matching placebo QD orally up to approximately 56 days.
|
Ezetimibe 10 mg and Bempedoic Acid 180 mg
n=100 participants at risk
Participants receive ezetimibe 10 mg, bempedoic acid 180mg, enlicitide-matching placebo orally QD for approximately 56 days.
|
|---|---|---|---|---|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/101 • 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.
|
2.0%
1/50 • Number of events 1 • 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.
|
0.00%
0/50 • 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.
|
0.00%
0/100 • 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.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/101 • 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.
|
0.00%
0/50 • 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.
|
2.0%
1/50 • Number of events 1 • 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.
|
0.00%
0/100 • 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.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/101 • 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.
|
2.0%
1/50 • Number of events 1 • 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.
|
0.00%
0/50 • 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.
|
0.00%
0/100 • 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.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/101 • 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.
|
2.0%
1/50 • Number of events 1 • 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.
|
0.00%
0/50 • 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.
|
0.00%
0/100 • 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.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/101 • 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.
|
2.0%
1/50 • Number of events 1 • 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.
|
0.00%
0/50 • 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.
|
0.00%
0/100 • 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.
|
Other adverse events
| Measure |
Enlicitide 20 mg
n=101 participants at risk
Participants receive enlicitide 20mg, ezetimibe-matching placebo, and bempedoic acid-matching placebo once daily (QD) orally up to approximately 56 days.
|
Bempedoic Acid 180 mg
n=50 participants at risk
Participants receive bempedoic acid 180mg, ezetimibe-matching placebo, and enlicitide-matching placebo QD orally up to approximately 56 days.
|
Ezetimibe 10 mg
n=50 participants at risk
Participants receive ezetimibe 10mg, enlicitide-matching placebo, and bempedoic acid-matching placebo QD orally up to approximately 56 days.
|
Ezetimibe 10 mg and Bempedoic Acid 180 mg
n=100 participants at risk
Participants receive ezetimibe 10 mg, bempedoic acid 180mg, enlicitide-matching placebo orally QD for approximately 56 days.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/101 • 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.
|
6.0%
3/50 • Number of events 3 • 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.
|
6.0%
3/50 • Number of events 4 • 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.
|
0.00%
0/100 • 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.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER