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Enlicitide Decanoate for High Cholesterol
Phase 3
Recruiting
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Has an ongoing serious adverse event considered related to study intervention by the investigator in the parent study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is looking at the safety and effectiveness of enlicitide decanoate in adults with high cholesterol who previously participated in other studies.
Who is the study for?
This trial is for adults with high cholesterol who have already completed one of the earlier enlicitide decanoate studies (MK-0616-013, MK-0616-017, or MK-0616-018). Specific eligibility details are not provided but typically include meeting certain health standards and previous study participation.
What is being tested?
The trial is testing the long-term safety and effectiveness of a drug called Enlicitide Decanoate in managing high cholesterol. This extension study follows up on participants from prior related trials to gather more data over a longer period.
What are the potential side effects?
While specific side effects are not listed here, common ones associated with PCSK9 inhibitors like Enlicitide may include injection site reactions, cold-like symptoms, and possibly muscle pain. Individual experiences can vary.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am experiencing a serious side effect from a previous study treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants who discontinue study drug due to an AE
Number of participants with one or more adverse events (AEs)
Secondary study objectives
Mean percent change from baseline of the parent study in LDL-C at Week 8 of this extension study
Mean percent change from baseline of the parent study in apolipoprotein B (ApoB) at Week 8 of this extension study
Mean percent change from baseline of the parent study in non-high-density lipoprotein cholesterol (non-HDL-C) at Week 8 of this Extension Study
+3 moreSide effects data
From 2022 Phase 2 trial • 381 Patients • NCT052611267%
Dyspepsia
5%
Arthralgia
4%
Fatigue
1%
COVID-19
1%
Nausea
1%
Cholecystitis
1%
Diarrhoea
1%
Deep vein thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
MK-0616 12 mg
MK-0616 18 mg
MK-0616 30 mg
Placebo
MK-0616 6 mg
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Enlicitide DecanoateExperimental Treatment1 Intervention
Participants will receive 20 mg of enlicitide decanoate orally once daily (QD)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enlicitide Decanoate
2024
Completed Phase 2
~450
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Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
4,015 Previous Clinical Trials
5,183,333 Total Patients Enrolled
5 Trials studying High Cholesterol
14,762 Patients Enrolled for High Cholesterol
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,889 Previous Clinical Trials
8,086,193 Total Patients Enrolled
2 Trials studying High Cholesterol
14,583 Patients Enrolled for High Cholesterol
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