Can a Once-Daily pill tame bad cholesterol?
NCT ID NCT07821944
First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time
Summary
Researchers are testing an oral drug called enlicitide decanoate in adults with hyperlipidemia, a condition marked by high cholesterol. The phase 3 trial enrolls 150 people in India who have had a heart-related event or face high risk, and who still have elevated LDL cholesterol. Participants receive either enlicitide or a placebo for 24 weeks. The study measures how much LDL cholesterol changes and tracks side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- enlicitide decanoate, an oral drug designed to lower LDL cholesterol
- What this could lead to
- If it works, this could add an oral option for people whose cholesterol stays high despite current treatments.
- What could go wrong
- The trial is limited to 150 adults in India, so results may not apply to everyone. Enlicitide may fail to lower cholesterol more than placebo, or it may cause side effects that make people stop taking it.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * History of a major atherosclerotic cardiovascular disease (ASCVD) event or if no history of a major ASCVD event, has one or more of the following: possible or definite diagnosis of heterozygous familial hypercholesterolemia (HeFH), diabetes mellitus, stable angina pectoris, transient ischemic attack or symptomatic peripheral arterial disease * Has a low-density lipoprotein cholesterol (LDL-C) ≥55 mg/dL or ≥70 mg/dL depending on medical history * Is treated with a moderate- or high-intensity statin OR is treated with low-intensity statin with documentation of intolerance to a moderate or high-intensity statin OR is not receiving statins with documentation of statin intolerance * If on any lipid-lowering therapies (LLTs), should be on a stable dose with no planned medication change Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Had a heart failure hospitalization within 3 months before Screening * Has unstable angina, a myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, or stroke within 3 months before Screening * Is undergoing or previously underwent an LDL-C apheresis program within 3 months before first study visit or plans to initiate an LDL-C apheresis program * Was previously treated/is being treated with certain other cholesterol lowering medications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors * Has a history of nephrotic syndrome * Has poorly controlled diabetes mellitus * Has hyperthyroidism or inadequately controlled hypothyroidism * Is actively receiving chemotherapy for malignancy or has a history of malignancy ≤3 years before Screening
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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