What Is Enlicitide Decanoate?
Enlicitide Decanoate is an investigational drug currently being studied in clinical trials. It is administered orally, typically as a tablet, and has been investigated both as a standalone medication and in combination with other drugs like rosuvastatin. The specific mechanism by which Enlicitide Decanoate works is not detailed in the available trial descriptions. It is being developed by Merck Sharp & Dohme LLC, which has sponsored all 28 clinical trials for this drug.
Research on Enlicitide Decanoate began with the first trial on October 7, 2021. The drug is primarily being investigated for its potential effects on cholesterol and lipid levels, as well as its pharmacokinetics (how the body processes the drug) in various populations.
Uses and Conditions Under Study
Enlicitide Decanoate is being investigated for several conditions, with a significant focus on lipid disorders. A total of 11 trials have explored its use in conditions related to high cholesterol and fats in the blood. These include Hypercholesterolemia (5 trials), Familial Hypercholesterolemia (2 trials), Hypercholesterolaemia (2 trials), Hyperlipidemia (1 trial), and Arteriosclerosis (1 trial). These studies aim to understand if Enlicitide Decanoate can help manage or reduce elevated cholesterol levels, which are risk factors for cardiovascular disease.
Beyond lipid disorders, Enlicitide Decanoate is also being studied to understand how its pharmacokinetics are affected by different health conditions. Four trials have investigated the drug in individuals with impaired kidney or liver function. These include studies in Moderate Renal Impairment (1 trial), Renal Impairment (1 trial), Hepatic Impairment (1 trial), and Hepatic Insufficiency (1 trial). These studies are crucial for determining appropriate dosing for patients with these conditions.
The majority of trials, 18 in total, have involved healthy participants. These studies typically assess the drug's safety, tolerability, and how it is absorbed, distributed, metabolized, and excreted in individuals without specific health conditions, often as part of early-phase development.
Dosing
Enlicitide Decanoate is primarily studied as an oral tablet. Clinical trials have explored various dosing approaches, often referred to as "Dose regimen A," "Dose regimen B," and "Dose regimen C," to identify optimal therapeutic effects and safety profiles. In some studies, a single dose of enlicitide is administered orally on day 1 of a testing period.
The drug has been investigated in several combinations. Notably, an Enlicitide/rosuvastatin fixed dose combination (FDC) has been studied, as well as combinations with other medications such as Lithium Carbonate, Semaglutide, Atorvastatin, Levothyroxine, Alendronate, Warfarin, and Lisinopril. One specific study mentioned a dose of 20mg enlicitide combined with 180mg Sodium Caprate.
Studies have also examined the impact of food and water on the drug's absorption, with specific regimens like "Enlicitide Coffee Sequence 1" and "Enlicitide Decanoate Food Effect." Different panels of participants, including those with moderate to severe renal impairment and end-stage renal disease, have been studied to understand how these conditions affect the drug's processing in the body.
Side Effects
In clinical trials, the most common side effect reported by patients taking Enlicitide Decanoate was nasopharyngitis (common cold symptoms), experienced by 9.4% of patients, compared to 7.9% of those taking a placebo. Other common side effects that occurred more frequently in patients taking Enlicitide Decanoate than placebo included:
- Accidental overdose: 7.9% of patients on Enlicitide Decanoate experienced this, compared to 4.0% on placebo.
- Headache: 7.9% of patients on Enlicitide Decanoate, compared to 6.9% on placebo.
- Nausea: 7.9% of patients on Enlicitide Decanoate, compared to 6.9% on placebo.
- Diarrhea: 7.4% of patients on Enlicitide Decanoate, compared to 2.0% on placebo.
- Dizziness: 6.9% of patients on Enlicitide Decanoate, compared to 4.0% on placebo.
Less common side effects, such as influenza (8.4% on drug vs 8.9% on placebo), upper respiratory tract infection (5.0% on drug vs 5.9% on placebo), and arthralgia (joint pain) (3.0% on drug vs 5.9% on placebo
Currently Recruiting Trials
Enlicitide Decanoate is currently being investigated in clinical trials for conditions related to high cholesterol. These studies aim to understand its safety and effectiveness in different patient populations, offering opportunities for individuals to contribute to medical research.
One ongoing study, NCT07216482, is a Phase 3 clinical trial for participants with high cholesterol, specifically hyperlipidemia. Researchers are studying a medicine called enlicitide, which is designed to lower low-density lipoprotein cholesterol (LDL-C), often referred to as "bad" cholesterol. This study will compare the effects of enlicitide alone, enlicitide combined with rosuvastatin (a standard treatment for lowering LDL-C), and rosuvastatin alone. The goal is to learn how enlicitide works both on its own and in combination with an established medication. The trial plans to enroll approximately 975 participants.
Another trial, NCT07058077, is a Phase 2/3 study focusing on children and adolescents diagnosed with heterozygous familial hypercholesterolemia (HeFH). This is a genetic condition that causes very high amounts of LDL-C in the blood from a young age. The study aims to determine if enlicitide decanoate is a safe and effective treatment specifically for this younger population. It is designed to enroll around 153 participants and includes different parts for evaluating dosages and an open-label extension, allowing researchers to gather comprehensive data on the drug's impact.
Where to Participate
Clinical trials for Enlicitide Decanoate are currently recruiting across a wide geographic area, making participation accessible to many individuals. Studies are active at 41 sites in 39 cities across 22 states.
Some of the top locations with recruiting sites include:
- San Antonio, Texas (2 sites)
- Chicago, Illinois (2 sites)
- Phoenix, Arizona (1 site)
- Tempe, Arizona (1 site)
- Lancaster, California (1 site)
- Sacramento, California (1 site)
- Colorado Springs, Colorado (1 site)
- Wilmington, Delaware (1 site)
- Washington D.C., District of Columbia (1 site)
- Boca Raton, Florida (1 site)
Eligibility for these trials generally includes individuals between 6 and 64 years of age, of all genders. Participants must have the specific medical condition being studied, as healthy volunteers are not being recruited for these trials. Children are eligible to participate in certain studies.
Development Timeline
The journey of Enlicitide Decanoate began on October 7, 2021, with its first clinical trial. Since then, its development has been consistently driven by Merck Sharp & Dohme LLC, which has sponsored all 28 clinical trials for this investigational medicine.
Initially, researchers explored Enlicitide Decanoate for conditions such as IBS-C and hyperphosphatemia. Over time, the development pipeline significantly expanded to address a broader range of conditions, particularly those related to cholesterol management. This expansion included studies for Familial Hypercholesterolemia, Hypercholesterolaemia, Hyperlipidemia, and Heterozygous Familial Hypercholesterolemia (HeFH). Additionally, research broadened to investigate its effects in patients with Moderate Renal Impairment, Arteriosclerosis, Renal Impairment, Hepatic Impairment, and Hepatic Insufficiency, reflecting a comprehensive approach to understanding its potential applications and safety across diverse patient populations.
The development has progressed through various stages, with the majority of studies being in Phase 1. As the understanding of Enlicitide Decanoate deepened, the program advanced, with 6 trials reaching Phase 3 and one trial designated as Phase 2/3, indicating significant progress towards potential regulatory approval. The overall research effort has involved a substantial number of participants, with a total enrollment of 22,873 across all trials, and the latest trial is projected to conclude by March 2026.