Cure My Disease

Don't miss your cure!

 Log in / Sign up

New pill combo aims to crush bad cholesterol

NCT ID NCT07216482

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 02, 2026 · Updated 5 times

Summary

This phase 3 trial tests whether adding enlicitide decanoate to the standard statin rosuvastatin lowers LDL cholesterol more than placebo in 975 adults with high cholesterol. Participants take the drugs or matching placebos for 8 weeks. The main goal is to see the percent change in LDL-C from start to week 8.

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 (also called MK-0616) and rosuvastatin
What this could lead to
If it works, this could offer a new combination pill that lowers 'bad' cholesterol more effectively than current treatments.
What could go wrong
This is a late-stage trial, but results may not apply to everyone with high cholesterol. Side effects or lack of added benefit over existing drugs are possible.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

996 people

The number who actually took part.

Started

Nov 2025

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 64 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Hyperlipidemia are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

hyperlipidemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hyperlipidemia

Contacts and locations

Locations

  • Alliance for Multispecialty Research LLC ( Site 0049)

    Tempe, Arizona, 85281, United States

  • Alliance for Multispecialty Research, LLC ( Site 0040)

    Fort Myers, Florida, 33912, United States

  • Alliance for Multispecialty Research, LLC ( Site 0048)

    Newton, Kansas, 67114, United States

  • Alliance for Multispecialty Research, LLC - Norman ( Site 0043)

    Norman, Oklahoma, 73069, United States

  • Australian Clinical Research Network ( Site 0900)

    Maroubra, New South Wales, 2035, Australia

  • Baker - HeartWest ( Site 0902)

    Hoppers Crossing, Victoria, 3029, Australia

  • Barzilai Medical Center ( Site 0504)

    Ashkelon, 7830604, Israel

  • Borbánya Praxis ( Site 1103)

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4405, Hungary

  • CEMEDIC ( Site 0201)

    CABA, Buenos Aires, C1407GTL, Argentina

  • CIPREC-CIPREC Sede Arenales ( Site 0200)

    Buenos Aires, Buenos Aires F.D., C1061AAS, Argentina

  • Cardiology Consultants of Philadelphia Yardley ( Site 0016)

    Yardley, Pennsylvania, 19067, United States

  • Cardiovascular Associates of the Delaware Valley ( Site 0035)

    Elmer, New Jersey, 08318, United States

  • Care Access - Thunder Bay ( Site 0130)

    Thunder Bay, Ontario, P7B 7C7, Canada

  • Central Research Associates ( Site 0009)

    Birmingham, Alabama, 35205, United States

  • Centricity Research Mirabel Multispecialty ( Site 0107)

    Mirabel, Quebec, J7J 2K8, Canada

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0206)

    CABA, C1425AGC, Argentina

  • Centro de Pesquisa Clinica do Coracao ( Site 0303)

    Aracaju, Sergipe, 49055-530, Brazil

  • Centro de Pesquisas em Diabetes e Doenças Endócrino-Metabólicas ( Site 0306)

    Fortaleza, Ceará, 60430-350, Brazil

  • Centro de Salud Concepcion Arenal ( Site 0603)

    Santiago de Compostela, Galicia, 15701, Spain

  • Chemidox Clinical Trials ( Site 0008)

    Lancaster, California, 93534, United States

  • Clalit Health Services - Sakhnin Community Clinic ( Site 0502)

    Sakhnin, 3081000, Israel

  • Clinical Research Trials of Florida ( Site 0001)

    Tampa, Florida, 33607, United States

  • Clinical Site Partners LLC, dba CSP Orlando ( Site 0014)

    Winter Park, Florida, 32789, United States

  • Clinical Trials Research ( Site 0036)

    Sacramento, California, 95821, United States

  • Clinical Trials of Texas, Inc. ( Site 0010)

    San Antonio, Texas, 78229, United States

  • Conquest Research ( Site 0045)

    Arlington, Virginia, 22205, United States

  • Cotton O'Neil Clinical Research Center ( Site 0006)

    Topeka, Kansas, 66606, United States

  • DRC Gyógyszervizsgáló Központ ( Site 1109)

    Balatonfüred, Veszprém megye, 8230, Hungary

  • Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Anyagcsere Tanszék) ( Site 1102)

    Debrecen, 4032, Hungary

  • EAP Sardenya ( Site 0601)

    Barcelona, 08025, Spain

  • EBA Centelles ( Site 0600)

    Barcelona, 08540, Spain

  • East Coast Institute for Research ( Site 0041)

    Lake City, Florida, 32055, United States

  • Emeritus Research ( Site 0904)

    Camberwell, Victoria, 3124, Australia

  • Erciyes Universitesi Tıp Fakultesi Hastaneleri ( Site 0701)

    Kayseri, 38030, Turkey (Türkiye)

  • Eskisehir Osmangazi University ( Site 0705)

    Eskişehir, 26480, Turkey (Türkiye)

  • Fundacion Estudios Clinicos ( Site 0203)

    Rosario, Santa Fe Province, S2000CVD, Argentina

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0309)

    São José do Rio Preto, São Paulo, 15090-000, Brazil

  • Fusion Clinical Research ( Site 0901)

    Norwood, South Australia, 5067, Australia

  • G A Research Associates ( Site 0102)

    Moncton, New Brunswick, E1G 1A7, Canada

  • G&L Research ( Site 0024)

    Foley, Alabama, 36535, United States

  • Great Lakes Clinical Trials - Ravenswood ( Site 0018)

    Chicago, Illinois, 60640, United States

  • Hacettepe Universite Hastaneleri ( Site 0700)

    Sıhhiye, Ankara, 06230, Turkey (Türkiye)

  • Health Research of Hampton Roads, Inc. ( Site 0013)

    Newport News, Virginia, 23606, United States

  • Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0305)

    Bragança Paulista, São Paulo, 12916-542, Brazil

  • IBPClin - Instituto Brasil de Pesquisa Clínica ( Site 0302)

    Rio de Janeiro, 20241-180, Brazil

  • Inpatient Research Clinic ( Site 0017)

    Miami Lakes, Florida, 33014, United States

  • Instituto de Cardiología "Juana F. Cabral"-Cardiología ( Site 0205)

    Corrientes, W3400AMZ, Argentina

  • Instituto de Investigaciones Clinicas Rosario ( Site 0204)

    Rosario, Santa Fe Province, S2000CVD, Argentina

  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0202)

    Mar del Plata, Buenos Aires, B7600FZO, Argentina

  • Istanbul Universitesi - Cerrahpasa Kardiyoloji Enstitusu ( Site 0703)

    Istanbul, 34080, Turkey (Türkiye)

  • Jubilee Clinical Research ( Site 0031)

    Las Vegas, Nevada, 89106, United States

  • L-MARC Research Center ( Site 0004)

    Louisville, Kentucky, 40213, United States

  • Lakeland Clinical Trials Waikato ( Site 1000)

    Nawton, Waikato Region, 3200, New Zealand

  • Lakeland Clinical Trials Wellington ( Site 1002)

    Upper Hutt, Wellington Region, 5018, New Zealand

  • Lakeside Surgery ( Site 0802)

    Corby, Northamptonshire, NN17 2UR, United Kingdom

  • Lausmed Egészségügyi Szolgáltató ( Site 1105)

    Baja, Bács-Kiskun county, 6500, Hungary

  • Legacy Clinical Trials ( Site 0044)

    Colorado Springs, Colorado, 80909, United States

  • LinQ Research ( Site 0025)

    Pearland, Texas, 77584, United States

  • LinQ Research - Tomball ( Site 0047)

    Tomball, Texas, 77375, United States

  • Linn Medical Center ( Site 0503)

    Haifa, 3100000, Israel

  • Manassas Clinical Research Center ( Site 0002)

    Manassas, Virginia, 20110, United States

  • Meir Medical Center. ( Site 0501)

    Kfar Saba, 4428164, Israel

  • Midwest Institute For Clinical Research ( Site 0033)

    Indianapolis, Indiana, 46260-5310, United States

  • Milestone Research Inc. ( Site 0111)

    London, Ontario, N5W 6A2, Canada

  • Momentum Clinical Research Taringa ( Site 0907)

    Taringa, Queensland, 4068, Australia

  • Momentum Darlinghurst ( Site 0906)

    Sydney, New South Wales, 2010, Australia

  • National Clinical Research, Inc ( Site 0028)

    Richmond, Virginia, 23294, United States

  • New Mexico Clinical Research & Osteoporosis Center, Inc. ( Site 0027)

    Albuquerque, New Mexico, 87106-4725, United States

  • North York Diagnostic and Cardiac Centre ( Site 0110)

    North York, Ontario, M6B 3H7, Canada

  • Pacific Clinical Research Network - Forte ( Site 1004)

    Christchurch, Canterbury, 8013, New Zealand

  • Pacific Clinical Research Network - Rotorua ( Site 1001)

    Rotorua, Bay of Plenty, 3010, New Zealand

  • Pacific Clinical Research Network - Tasman ( Site 1003)

    Nelson, Tasman District, 7011, New Zealand

  • Permian Research Foundation ( Site 0005)

    Odessa, Texas, 79761, United States

  • Provecta Research Network LLC ( Site 0022)

    Houston, Texas, 77027, United States

  • Rainier Clinical Research ( Site 0023)

    Renton, Washington, 98057, United States

  • Rambam Health Care Campus ( Site 0500)

    Haifa, 3109601, Israel

  • Recherche Clinique Sigma Inc ( Site 0108)

    Québec, Quebec, G1G 5X1, Canada

  • Soffer Health Institute ( Site 0046)

    Hollywood, Florida, 33020, United States

  • Stone Oak, LLC dba Discovery Clinical Trials (DCT) ( Site 0021)

    San Antonio, Texas, 78258, United States

  • Synexus Clinical Research US, Inc. - Phoenix Central ( Site 0030)

    Phoenix, Arizona, 85020, United States

  • Trialmed ( Site 0026)

    Chicago, Illinois, 60602, United States

  • Ufuk University Dr.Ridvan Ege Hospital ( Site 0709)

    Ankara, 06520, Turkey (Türkiye)

  • Velocity Clinical Research Havering ( Site 0804)

    London, Havering, RM1 3PJ, United Kingdom

  • Velocity Clinical Research Romford ( Site 0803)

    Bristol, Bristol, City of, BS8 2RA, United Kingdom

  • West Walk Surgery ( Site 0801)

    Yate, Gloucestershire, BS37 4AX, United Kingdom

  • William Harvey Heart Centre ( Site 0800)

    London, London, City of, EC1M 6BQ, United Kingdom

  • İnönü Üniversitesi Turgut Özal Tıp Merkezi ( Site 0702)

    Malatya, 44280, Turkey (Türkiye)

More trials for these conditions

Other studies related to the condition(s) this trial covers.