Trial · Interventional

CompletedPhase 2Results postedRegistry data

A Study of the Efficacy and Safety of Enclitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-008)

NCTNCT05261126Other id0616-008Other idMK-0616-008Other idjRCT2031210701Other id2021-005221-24

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 381 participants (actual)
Sponsor: Merck Sharp & Dohme LLC · Industry
Design: Randomized · Double masking
Countries: 8 countries
United States, Germany, Japan, Mexico, Norway, South Korea, Turkey (Türkiye), United Kingdom
Start: 10 Mar 2022
Primary completion: 28 Nov 2022
Completion: 28 Nov 2022
First posted: 2 Mar 2022
Last update posted: 9 Dec 2024
Conditions: Hypercholesterolemia · Familial Hypercholesterolemia

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20222023

Ph 2
A Study of the Efficacy and Safety of Enclitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-008)
NCT05261126
10 Mar 2022 to 28 Nov 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to evaluate the efficacy and safety of enclitide chloride, an oral PCSK9 inhibitor, in lowering low-density lipoprotein cholesterol (LDL-C) in participants with hypercholesterolemia. The primary hypothesis is that at least one of the four doses of enclitide chloride tested in this study is superior to placebo on percent change from baseline in LDL-C at Week 8.

Interventions

Enclitide ChlorideDrug
PlaceboDrug

Arms5

Experimental
Enclitide Chloride 6 mg
Participants will receive 6 mg of enlicitide chloride orally QD for 8 weeks
Experimental
Enclitide Chloride 12 mg
Participants will receive 12 mg of enlicitide chloride orally QD for 8 weeks
Experimental
Enclitide Chloride 18 mg
Participants will receive 18 mg of enlicitide chloride orally QD for 8 weeks
Experimental
Enclitide Chloride 30 mg
Participants will receive 30 mg of enlicitide chloride orally QD for 8 weeks
Placebo comparator
Placebo
Participants will receive enlicitide chloride-matching placebo orally QD for 8 weeks

Primary outcomes3

Outcomes the sponsor listed as primary.

Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 8
Time frame · Baseline and up to Week 8
Registry description
Blood samples were collected at baseline and after 8 weeks of treatment to assess mean percent change in LDL-C. Based on a constrained longitudinal analysis (cLDA) model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time. The percent change from baseline in LDL-C at week 8 was reported.
Percentage of Participants Who Experienced One or More Adverse Events (AEs)
Time frame · Up to approximately 17 Weeks
Registry description
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 be 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 at least one AE was reported.
Percentage of Participants Who Discontinued Study Intervention Due to AEs
Time frame · Up to approximately 9 Weeks
Registry description
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 be 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 AEs was reported.

Secondary outcomes(3)

Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 8
Time frame · Baseline and up to Week 8
Registry description
Blood samples were collected at baseline and after 8 weeks of treatment to assess mean percent change in ApoB. The least square mean and 95% CI were obtained from fitting a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time. The percent change from baseline in ApoB at week 8 was reported.
Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 8
Time frame · Baseline and up to Week 8
Registry description
Blood samples were collected at baseline and after 8 weeks of treatment to assess mean percent change in non-HDL-C. The least square mean and 95% CI were obtained from fitting a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time. The percent change from baseline in non-HDL-C at week 8 was reported.
Percentage of Participants With LDL-C Value at Goal at Week 8
Time frame · Week 8
Registry description
LDL-C goal was defined as: LDL-C \<70 mg/dL (\<1.81 mmol/L) in participants with clinical atherosclerotic cardiovascular disease (ASCVD), LDL-C \<100 mg/dL (\<2.59 mmol/L) in participants with an ASCVD risk-equivalent and/or a 10-year risk of having an ASCVD event that is ≥7.5%, OR LDL-C \<130 mg/dL (\<3.37mmol/L) in participants with a 10-year risk of having an ASCVD event that is ≥5.0% and \<7.5%. The percentage of participants with LDL-C value at goal at week 8 were reported.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline and up to Week 8

Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 8

Group	Value (Percentage Change)
MK-0616 6 mg	-40.0
MK-0616 12 mg	-54.5
MK-0616 18 mg	-57.9
MK-0616 30 mg	-59.7
Placebo	1.2

Primary outcomeNumber· Up to approximately 17 Weeks

Percentage of Participants Who Experienced One or More Adverse Events (AEs)

Group	Value (Percentage of Participants)
MK-0616 6 mg	44.2
MK-0616 12 mg	39.5
MK-0616 18 mg	43.4
MK-0616 30 mg	42.1
Placebo	44.0

Primary outcomeNumber· Up to approximately 9 Weeks

Percentage of Participants Who Discontinued Study Intervention Due to AEs

Group	Value (Percentage of Participants)
MK-0616 6 mg	2.6
MK-0616 12 mg	0.0
MK-0616 18 mg	2.6
MK-0616 30 mg	2.6
Placebo	1.3

Secondary and other outcome results(3)

Secondary outcomeLeast squares mean· Baseline and up to Week 8

Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 8

Group	Value (Percentage Change)
MK-0616 6 mg	-32.8
MK-0616 12 mg	-45.8
MK-0616 18 mg	-48.7
MK-0616 30 mg	-51.8
Placebo	0.0

Secondary outcomeLeast squares mean· Baseline and up to Week 8

Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 8

Group	Value (Percentage Change)
MK-0616 6 mg	-34.4
MK-0616 12 mg	-49.0
MK-0616 18 mg	-51.8
MK-0616 30 mg	-54.3
Placebo	1.5

Secondary outcomeNumber· Week 8

Percentage of Participants With LDL-C Value at Goal at Week 8

Group	Value (Percentage of Participants)
MK-0616 6 mg	80.5
MK-0616 12 mg	85.5
MK-0616 18 mg	90.8
MK-0616 30 mg	90.8
Placebo	9.3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
MK-0616 6 mgParticipants received 6 mg of MK-0616 orally QD for 8 weeks	0 / 77	1 / 77	11 / 77
MK-0616 12 mgParticipants received 12 mg of MK-0616 orally QD for 8 weeks	0 / 76	3 / 76	13 / 76
MK-0616 18 mgParticipants received 18 mg of MK-0616 orally QD for 8 weeks	1 / 76	2 / 76	15 / 76
MK-0616 30 mgParticipants received 30 mg of MK-0616 orally QD for 8 weeks	0 / 76	2 / 76	8 / 76
PlaceboParticipants received MK-0616-matching placebo orally QD for 8 weeks	0 / 76	0 / 75	15 / 75

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2023

6 results

Phase 2b Randomized Trial of the Oral PCSK9 Inhibitor MK-0616.

Ballantyne et al. 2023Journal of the American College of Cardiologycited by 162

PMID 36889610DOI 10.1016/j.jacc.2023.02.018PUB-36889610

Full text at the publisher6 results

Publisher page See results (6)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 80 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * History of clinical atherosclerotic cardiovascular disease (ASCVD), or has an ASCVD risk equivalent and/or a 10-year risk of having an ASCVD event ≥5.0%, AND has a corresponding LDL-C that falls within the protocol-specified range at screening. * Treatment with a stable dose of one or more lipid-lowering therapies for ≥30 days before screening, or has not received treatment with any lipid-lowering therapy for ≥30 days before screening. * A female participant is not pregnant or breastfeeding, not a woman of child-bearing potential (WOCBP) or is a WOCBP and agrees to follow contraceptive guidance during the intervention period and for at least 8 weeks after the last dose of study intervention. Exclusion Criteria: * History of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria. * History of nephrotic syndrome. * History of unstable angina, a myocardial infarction, percutaneous transluminal coronary angioplasty, transient ischemic attack, or stroke within 3 months before Screening. * Has poorly controlled diabetes mellitus, defined as hemoglobin A1C (A1C) ≥9.0% at Screening. * History of malignancy ≤3 years before screening, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, which have no timeframe limitations relative to screening. * Currently participating in or has previously participated in an interventional clinical study within 3 months before Screening. * Has moderate or greater renal insufficiency.

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