Enlicitide + Rosuvastatin for High Cholesterol
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines a new medicine, enlicitide, to determine if it can lower bad cholesterol (LDL-C) in the blood when combined with rosuvastatin, a commonly used cholesterol-lowering drug. The trial compares the effects of taking enlicitide with rosuvastatin to taking each one alone or a placebo (a pill with no active medicine). It targets individuals who haven’t recently used cholesterol-lowering drugs and wish to manage high cholesterol levels. Participants must not have specific heart or muscle conditions or be unable to take statins due to side effects. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.
Will I have to stop taking my current medications?
The trial does not clearly state if you must stop your current medications, but you cannot have taken certain lipid-lowering therapies recently or any medication that interacts with rosuvastatin before the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that enlicitide, whether used alone or with rosuvastatin, is generally safe for people. Studies have found that enlicitide significantly lowers bad cholesterol (LDL-C) and is well tolerated by adults with high cholesterol. One study showed that enlicitide reduced LDL cholesterol levels by 57.1%, with no major safety concerns reported. Most participants did not experience serious side effects.
When combined with rosuvastatin, enlicitide has also shown promising results. This combination significantly reduces LDL-C, similar to enlicitide alone. While the combination aims to improve cholesterol control, current data does not indicate any new safety issues when both drugs are used together.
Rosuvastatin is already approved by the FDA for lowering cholesterol, making it a well-known option with a proven safety record. Overall, available evidence suggests that the combination of enlicitide and rosuvastatin is safe.12345Why are researchers excited about this trial's treatments?
Researchers are excited about enlicitide for high cholesterol because it offers a fresh approach different from existing options like statins. Unlike typical statins that mainly focus on blocking cholesterol production in the liver, enlicitide works on a new target, potentially improving cholesterol levels more effectively and with fewer side effects. Additionally, combining enlicitide with the well-known statin rosuvastatin might enhance overall cholesterol management, offering a promising dual-action strategy. This unique mechanism could provide a significant advantage for patients who don't fully respond to current statin therapies.
What evidence suggests that this trial's treatments could be effective for lowering LDL-C?
In this trial, participants will receive different treatments to manage high cholesterol. Studies have shown that enlicitide, one of the treatments, significantly lowers LDL cholesterol, often called "bad" cholesterol. Enlicitide alone can reduce LDL cholesterol by up to 60%, similar to some injectable treatments. Research indicates that enlicitide works well and is generally safe, making it a promising option for people with high cholesterol. Another treatment arm involves using enlicitide with rosuvastatin, which may enhance this effect, further lowering LDL cholesterol levels. Previous studies have shown significant reductions in LDL cholesterol with this combination, suggesting it could effectively manage high cholesterol.12356
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
This trial is for individuals with high cholesterol who haven't had certain lipid-lowering treatments recently or at all. Participants should be interested in testing a new medication, enlicitide, alongside rosuvastatin, which is an established cholesterol-lowering drug.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive enlicitide and rosuvastatin or placebo orally once daily for up to 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Enlicitide
Trial Overview
The study tests if enlicitide combined with rosuvastatin can lower bad cholesterol (LDL-C) more effectively than a placebo. A placebo looks like the medicine but doesn't contain any active ingredients. The comparison helps understand the true impact of enlicitide.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
Placebo Group
Participants will receive enlicitide and rosuvastatin. Both will be delivered orally QD for up to 12 weeks.
Participants will receive enlicitide and a rosuvastatin-matching placebo. Both will be delivered orally once daily (QD) for up to 12 weeks.
Participants will receive rosuvastatin and an enlicitide-matching placebo. Both will be delivered orally QD for up to 12 weeks.
Participants will receive an enlicitide-matching placebo and a rosuvastatin-matching placebo. Placebos will be delivered orally QD for up to 12 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLC
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
Citations
Merck's Enlicitide Decanoate, an Investigational Oral ...
Enlicitide demonstrated statistically significant reductions in secondary endpoints including non-high-density lipoprotein cholesterol (non-HDL- ...
Efficacy and Safety of Oral PCSK9 Inhibitor Enlicitide in ...
Conclusions: Among adults with HeFH, treatment with enlicitide was well tolerated and significantly reduced levels of LDL-C, apolipoprotein B, ...
3.
newsroom.heart.org
newsroom.heart.org/news/investigational-daily-pill-lowered-bad-cholesterol-as-much-as-injectablesInvestigational daily pill lowered bad cholesterol as much ...
The oral medication, enlicitide, lowered LDL cholesterol by up to 60% and could eventually offer an option for people whose LDL levels remain ...
New Drug Lowers 'Bad' Cholesterol by 58% in Clinical Trial
A once-daily enlicitide decanoate pill was shown to reduce LDL-C by an average of 58.2 percent after 24 weeks. Those given a placebo instead ...
Oral PCSK9 Inhibitor Enlicitide Cuts LDL Cholesterol
By 24 weeks, treatment with enlicitide resulted in a 57.1% reduction in LDL cholesterol compared with a 3.0% increase in the placebo group, ...
NCT07216482 | A Clinical Study of Enlicitide in ...
Researchers designed a study medicine called enlicitide to lower low-density lipoprotein cholesterol (LDL-C). In this study, researchers want to learn about ...
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