A Study to Evaluate the Efficacy and Safety of MK-0616 Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia (MK-0616-018)

Hypercholesterolemia Clinical Trial

Official title:

A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of MK-0616 Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06450366
• Other study ID #: 0616-018
• Secondary ID: MK-0616-0182023-
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: July 15, 2024
• Est. completion date: September 22, 2025

Study information

• Verified date: June 2024
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to assess whether MK-0616 is superior to ezetimibe or bempedoic acid or ezetimibe + bempedoic acid in reducing LDL-C in participants with hypercholesterolemia, and to evaluate its safety and tolerability. The primary study hypotheses are MK-0616 is superior to ezetimibe, bempedoic acid, and ezetimibe + bempedoic acid on mean percent change from baseline in LDL-C at week 8.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: September 22, 2025
• Est. primary completion date: July 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Has either a) history of a major atherosclerotic cardiovascular disease (ASCVD) event or b) if no history of a major ASCVD event, has intermediate to high risk for development of a first major ASCVD event

• Has fasted lipid values (evaluated by the central laboratory) at Visit 1 (Screening) as follows: a) history of a major ASCVD event with LDL-C =55 mg/dL (=1.42 mmol/L) OR b) No history of a major ASCVD event with LDL-C =70 mg/dL (=1.81 mmol/L)

• Is treated with a low, moderate, or high intensity statin (±non-statin lipid lowering therapy [LLT])

• Is on a stable dose of all background LLTs with no planned medication or dose changes during the study

• Is an individual of any sex/gender, from 18 years of age inclusive, at the time of providing the informed consent

Exclusion Criteria:

• Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous familial hypercholesterolemia (HeFH), or double HeFH

• Has New York Heart Association class IV heart failure, or last known left ventricular ejection fraction =25% by any imaging method, or had a heart failure hospitalization within 3 months before Visit 1 (Screening)

• Participants with a history of tendon disorder or tendon rupture

• Participants with a history of gout

• Is undergoing or previously underwent an LDL-C apheresis program within 3 months before Visit 1 (Screening) or plans to initiate an LDL-C apheresis program

• Was previously treated/is being treated with certain other cholesterol lowering medications, including ezetimibe, bempedoic acid, or protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• MK-0616
Administered orally.
• Ezetimibe
Administered orally.
• Bempedoic Acid
Administered orally.

Other:
• Placebo for MK-0616
Administered orally.
• Placebo for Ezetimibe
Administered orally.
• Placebo for Bempedoic Acid
Administered orally.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Percent Change from Baseline in LDL-C at Day 56	Blood samples will be collected at baseline and after 56 days of treatment to assess mean percentage change in LDL-C. The percent change from baseline in LDL-C at Day-56 will be reported.	Baseline and Day 56
Secondary	Mean Percent Change from Baseline in Apolipoprotein B (ApoB) at Day 56	Blood samples will be collected at baseline and on day 56 of treatment to assess mean percent change in ApoB. The percent change from baseline in ApoB at Day 56 will be reported.	Baseline and Day 56
Secondary	Mean Percent Change from Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Day 56	Blood samples will be collected at baseline and on day 56 of treatment to assess mean percent change in non-HDL-C. The percent change from baseline in non-HDL-C at 56 days will be reported.	Baseline and Day 56
Secondary	Percent Change from Baseline in Lipoprotein(a) Levels (Lp[a])	Blood samples will be collected at baseline and on day 56 of treatment to assess percent change in Lp(a) levels. The change from baseline at Day 56 will be reported.	Baseline and Day 56
Secondary	Percentage of Participants Who at Day 56 Have an LDL-C <70 mg/dL and =50% Reduction from Baseline	The percentage of participants who have an LDL-C <70 mg/dL and >50% reduction from baseline at day 56 will be reported.	Baseline and Day 56
Secondary	Percentage of Participants Who at Day 56 Have an LDL-C <55 mg/dL and =50% Reduction from Baseline	The percentage of participants who have an LDL-C <55 mg/dL and >50% reduction from baseline at day 56 will be reported.	Baseline and Day 56
Secondary	Number 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.	Up to Approximately 112 days
Secondary	Number of Participants Discontinuing from Study Therapy 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.	Up to Approximately 56 days

External Links

•   Merck Clinical Trials Information