Enlicitide Decanoate and Rosuvastatin for Hyperlipidemia Treatment
This clinical trial aims to test if Enlicitide Decanoate combined with Rosuvastatin is effective in treating high cholesterol levels (hyperlipidemia) compared to a placebo, by measuring the change in LDL-cholesterol after 8 weeks.
Enlicitide
+ Placebo for Rosuvastatin
+ Rosuvastatin
Hyperlipidemias+2
+ Metabolic Diseases
+ Nutritional and Metabolic Diseases
Treatment Study
Summary
Study start date: November 11, 2025
Actual date on which the first participant was enrolled.This study focuses on people with hyperlipidemia, a condition where there are high levels of fatty substances in the blood, including low-density lipoprotein cholesterol (LDL-C), often called "bad cholesterol." The study aims to test whether a new medicine, enlicitide, when used together with the commonly prescribed drug rosuvastatin, can lower LDL-C levels more effectively than rosuvastatin alone. This is important because reducing LDL-C levels can lower the risk of heart disease and improve heart health. Participants in the study will be randomly assigned to receive either the combination of enlicitide and rosuvastatin or a placebo with rosuvastatin. A placebo is a harmless pill that looks like the real medicine but doesn’t contain any active ingredients. This helps researchers determine the true effects of the new medicine. The study will closely monitor changes in LDL-C levels in participants' blood to evaluate the effectiveness of the treatment. This process will ensure a clear understanding of how well the new combination works compared to the standard treatment alone.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.975 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 64 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: -Has either not received lipid-lowering therapy (LLT) or has not received certain LLTs within a specified time period prior to the study. Exclusion Criteria: * Has a history of homozygous familial hypercholesterolemia (FH), compound heterozygous FH, or double heterozygous FH. * Had a heart failure hospitalization within 3 months before Screening. * Is unwilling to take a statin, and/or has a history of statin-associated muscle symptoms or other statin-related AEs to any statin and dose, and/or is known to be intolerant to 1 or more statins. * Has a history of any of the following conditions: (1) Myopathy, myositis, rhabdomyolysis, or unexplained muscle pain; (2) Muscular or neuromuscular disease; (3) Neuropathy, fibromyalgia, or chronic pain; or (4) Has a personal or family history of hereditary muscular disorders. * Has active or chronic hepatobiliary or hepatic disease. * Has known human immunodeficiency virus (HIV) infection. * Is undergoing or previously underwent an LDL-C apheresis program within 3 months before Screening or plans to initiate an LDL-C apheresis program. * Has received any medication that may interact with rosuvastatin within 5 half-lives prior to Screening or is planning to initiate such treatment.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
25% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
Active ComparatorGroup IV
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 87 locations
William Harvey Heart Centre ( Site 0800)
London, United KingdomOpen William Harvey Heart Centre ( Site 0800) in Google MapsLakeside Surgery ( Site 0802)
Corby, United KingdomCentral Research Associates ( Site 0009)
Birmingham, United StatesG&L Research ( Site 0024)
Foley, United States