Actively Recruiting
A Phase 3 Study to Evaluate the Effectiveness and Safety of Enlicitide with Rosuvastatin in Adults With High Cholesterol
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-28
975
Participants Needed
89
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a medicine called enlicitide to lower low-density lipoprotein cholesterol (LDL-C) in people with high cholesterol. This trial aims to learn if enlicitide given with rosuvastatin, a standard cholesterol-lowering treatment, works better than a placebo. The study is a phase 3, randomized, double-blind, placebo-controlled trial evaluating the combination's effect on LDL-C levels in adults with hyperlipidemia. Participants will be assigned to one of four groups: enlicitide with a placebo matching rosuvastatin, enlicitide with rosuvastatin, rosuvastatin with a placebo matching enlicitide, or placebos for both drugs. All treatments are taken orally once daily for up to 12 weeks. This setup helps researchers compare the effects of enlicitide alone, rosuvastatin alone, their combination, and placebo. During the study, participants will have their LDL-C levels measured at baseline and at weeks 8 and 12. Researchers will also monitor apolipoprotein B, non-high-density lipoprotein cholesterol, lipoprotein(a), and adverse events. The main outcome is the percent change in LDL-C at week 8. Safety and tolerability are assessed throughout the treatment and up to about 20 weeks. The total participation duration is up to 12 weeks of treatment with follow-up monitoring.
CONDITIONS
Brief Title
A Clinical Study of Enlicitide in Participants With High Cholesterol (MK-0616-037)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 64 years
- Have either not received lipid-lowering therapy recently or have not received certain lipid-lowering treatments within a specified time before the study
- Willing to take statin medication
You will not qualify if you...
- History of homozygous familial hypercholesterolemia or similar genetic cholesterol disorders
- Hospitalization for heart failure within 3 months before screening
- Unwillingness to take statins or history of statin-associated muscle symptoms or intolerance
- History of muscle diseases such as myopathy, myositis, rhabdomyolysis, unexplained muscle pain, muscular or neuromuscular diseases, neuropathy, fibromyalgia, or chronic pain
- Active or chronic liver or biliary disease
- Known HIV infection
- Undergoing or planning LDL-C apheresis within 3 months before screening
- Use of medications that may interact with rosuvastatin within 5 half-lives before screening or planning to start such medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive enlicitide, rosuvastatin, or matching placebos orally once daily for up to 12 weeks to evaluate their effectiveness and safety on high cholesterol.
Baseline visit and follow-up visits at Week 8 and Week 12
Trial Site Locations
Total: 89 locations
1
Central Research Associates ( Site 0009)
Birmingham, Alabama, United States, 35205
Actively Recruiting
2
G&L Research ( Site 0024)
Foley, Alabama, United States, 36535
Actively Recruiting
3
Synexus Clinical Research US, Inc. - Phoenix Central ( Site 0030)
Phoenix, Arizona, United States, 85020
Active, Not Recruiting
4
Alliance for Multispecialty Research LLC ( Site 0049)
Tempe, Arizona, United States, 85281
Active, Not Recruiting
5
Chemidox Clinical Trials ( Site 0008)
Lancaster, California, United States, 93534
Actively Recruiting
6
Clinical Trials Research ( Site 0036)
Sacramento, California, United States, 95821
Actively Recruiting
7
Legacy Clinical Trials ( Site 0044)
Colorado Springs, Colorado, United States, 80909
Actively Recruiting
8
Alliance for Multispecialty Research, LLC ( Site 0040)
Fort Myers, Florida, United States, 33912
Active, Not Recruiting
9
Soffer Health Institute ( Site 0046)
Hollywood, Florida, United States, 33020
Actively Recruiting
10
East Coast Institute for Research ( Site 0041)
Lake City, Florida, United States, 32055
Active, Not Recruiting
11
Inpatient Research Clinic ( Site 0017)
Miami Lakes, Florida, United States, 33014
Active, Not Recruiting
12
Clinical Research Trials of Florida ( Site 0001)
Tampa, Florida, United States, 33607
Active, Not Recruiting
13
Clinical Site Partners LLC, dba CSP Orlando ( Site 0014)
Winter Park, Florida, United States, 32789
Actively Recruiting
14
Trialmed ( Site 0026)
Chicago, Illinois, United States, 60602
Active, Not Recruiting
15
Great Lakes Clinical Trials - Ravenswood ( Site 0018)
Chicago, Illinois, United States, 60640
Active, Not Recruiting
16
Midwest Institute For Clinical Research ( Site 0033)
Indianapolis, Indiana, United States, 46260-5310
Active, Not Recruiting
17
Alliance for Multispecialty Research, LLC ( Site 0048)
Newton, Kansas, United States, 67114
Active, Not Recruiting
18
Cotton O'Neil Clinical Research Center ( Site 0006)
Topeka, Kansas, United States, 66606
Active, Not Recruiting
19
Monroe Biomedical Research ( Site 0004)
Louisville, Kentucky, United States, 40213
Actively Recruiting
20
Jubilee Clinical Research ( Site 0031)
Las Vegas, Nevada, United States, 89106
Actively Recruiting
21
Cardiovascular Associates of the Delaware Valley ( Site 0035)
Elmer, New Jersey, United States, 08318
Active, Not Recruiting
22
New Mexico Clinical Research & Osteoporosis Center, Inc. ( Site 0027)
Albuquerque, New Mexico, United States, 87106-4725
Active, Not Recruiting
23
Alliance for Multispecialty Research, LLC - Norman ( Site 0043)
Norman, Oklahoma, United States, 73069
Active, Not Recruiting
24
Cardiology Consultants of Philadelphia Yardley ( Site 0016)
Yardley, Pennsylvania, United States, 19067
Active, Not Recruiting
25
Provecta Research Network LLC ( Site 0022)
Houston, Texas, United States, 77027
Actively Recruiting
26
Permian Research Foundation ( Site 0005)
Odessa, Texas, United States, 79761
Active, Not Recruiting
27
LinQ Research ( Site 0025)
Pearland, Texas, United States, 77584
Active, Not Recruiting
28
Clinical Trials of Texas, Inc. ( Site 0010)
San Antonio, Texas, United States, 78229
Actively Recruiting
29
Stone Oak, LLC dba Discovery Clinical Trials (DCT) ( Site 0021)
San Antonio, Texas, United States, 78258
Active, Not Recruiting
30
LinQ Research - Tomball ( Site 0047)
Tomball, Texas, United States, 77375
Active, Not Recruiting
31
Conquest Research ( Site 0045)
Arlington, Virginia, United States, 22205
Active, Not Recruiting
32
Manassas Clinical Research Center ( Site 0002)
Manassas, Virginia, United States, 20110
Active, Not Recruiting
33
Health Research of Hampton Roads, Inc. ( Site 0013)
Newport News, Virginia, United States, 23606
Active, Not Recruiting
34
National Clinical Research, Inc ( Site 0028)
Richmond, Virginia, United States, 23294
Actively Recruiting
35
Rainier Clinical Research ( Site 0023)
Renton, Washington, United States, 98057
Active, Not Recruiting
36
CEMEDIC ( Site 0201)
CABA, Buenos Aires, Argentina, C1407GTL
Active, Not Recruiting
37
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0202)
Mar del Plata, Buenos Aires, Argentina, B7600FZO
Active, Not Recruiting
38
CIPREC-CIPREC Sede Arenales ( Site 0200)
Buenos Aires, Buenos Aires F.D., Argentina, C1061AAS
Active, Not Recruiting
39
Fundacion Estudios Clinicos ( Site 0203)
Rosario, Santa Fe Province, Argentina, S2000CVD
Active, Not Recruiting
40
Instituto de Investigaciones Clinicas Rosario ( Site 0204)
Rosario, Santa Fe Province, Argentina, S2000CVD
Active, Not Recruiting
41
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0206)
CABA, Argentina, C1425AGC
Active, Not Recruiting
42
Instituto de Cardiología "Juana F. Cabral"-Cardiología ( Site 0205)
Corrientes, Argentina, W3400AMZ
Active, Not Recruiting
43
Australian Clinical Research Network ( Site 0900)
Maroubra, New South Wales, Australia, 2035
Active, Not Recruiting
44
Momentum Darlinghurst ( Site 0906)
Sydney, New South Wales, Australia, 2010
Active, Not Recruiting
45
Momentum Clinical Research Taringa ( Site 0907)
Taringa, Queensland, Australia, 4068
Active, Not Recruiting
46
Fusion Clinical Research ( Site 0901)
Norwood, South Australia, Australia, 5067
Active, Not Recruiting
47
Emeritus Research ( Site 0904)
Camberwell, Victoria, Australia, 3124
Active, Not Recruiting
48
Baker - HeartWest ( Site 0902)
Hoppers Crossing, Victoria, Australia, 3029
Active, Not Recruiting
49
Centro de Pesquisas em Diabetes e Doenças Endócrino-Metabólicas ( Site 0306)
Fortaleza, Ceará, Brazil, 60430-350
Actively Recruiting
50
Centro de Pesquisa Clinica do Coracao ( Site 0303)
Aracaju, Sergipe, Brazil, 49055-530
Actively Recruiting
51
Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0305)
Bragança Paulista, São Paulo, Brazil, 12916-542
Actively Recruiting
52
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0309)
São José do Rio Preto, São Paulo, Brazil, 15090-000
Actively Recruiting
53
IBPClin - Instituto Brasil de Pesquisa Clínica ( Site 0302)
Rio de Janeiro, Brazil, 20241-180
Actively Recruiting
54
G A Research Associates ( Site 0102)
Moncton, New Brunswick, Canada, E1G 1A7
Active, Not Recruiting
55
Milestone Research Inc. ( Site 0111)
London, Ontario, Canada, N5W 6A2
Active, Not Recruiting
56
North York Diagnostic and Cardiac Centre ( Site 0110)
North York, Ontario, Canada, M6B 3H7
Actively Recruiting
57
Care Access - Thunder Bay ( Site 0130)
Thunder Bay, Ontario, Canada, P7B 7C7
Actively Recruiting
58
Centricity Research Mirabel Multispecialty ( Site 0107)
Mirabel, Quebec, Canada, J7J 2K8
Active, Not Recruiting
59
Institut de Cardiologie de Montreal ( Site 0109)
Montreal, Quebec, Canada, H1T 1C8
Actively Recruiting
60
Recherche Clinique Sigma Inc ( Site 0108)
Québec, Quebec, Canada, G1G 5X1
Active, Not Recruiting
61
Lausmed Egészségügyi Szolgáltató ( Site 1105)
Baja, Bács-Kiskun county, Hungary, 6500
Active, Not Recruiting
62
Borbánya Praxis ( Site 1103)
Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary, 4405
Active, Not Recruiting
63
DRC Gyógyszervizsgáló Központ ( Site 1109)
Balatonfüred, Veszprém megye, Hungary, 8230
Active, Not Recruiting
64
Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Anyagcsere Tanszék) ( Site 1102)
Debrecen, Hungary, 4032
Active, Not Recruiting
65
Barzilai Medical Center ( Site 0504)
Ashkelon, Israel, 7830604
Active, Not Recruiting
66
Linn Medical Center ( Site 0503)
Haifa, Israel, 3100000
Active, Not Recruiting
67
Rambam Health Care Campus ( Site 0500)
Haifa, Israel, 3109601
Active, Not Recruiting
68
Meir Medical Center. ( Site 0501)
Kfar Saba, Israel, 4428164
Active, Not Recruiting
69
Clalit Health Services - Sakhnin Community Clinic ( Site 0502)
Sakhnin, Israel, 3081000
Active, Not Recruiting
70
Pacific Clinical Research Network - Rotorua ( Site 1001)
Rotorua, Bay of Plenty, New Zealand, 3010
Active, Not Recruiting
71
Pacific Clinical Research Network - Forte ( Site 1004)
Christchurch, Canterbury, New Zealand, 8013
Active, Not Recruiting
72
Pacific Clinical Research Network - Tasman ( Site 1003)
Nelson, Tasman District, New Zealand, 7011
Active, Not Recruiting
73
Lakeland Clinical Trials Waikato ( Site 1000)
Nawton, Waikato Region, New Zealand, 3200
Active, Not Recruiting
74
Lakeland Clinical Trials Wellington ( Site 1002)
Upper Hutt, Wellington Region, New Zealand, 5018
Active, Not Recruiting
75
Centro de Salud Concepcion Arenal ( Site 0603)
Santiago de Compostela, Galicia, Spain, 15701
Active, Not Recruiting
76
EAP Sardenya ( Site 0601)
Barcelona, Spain, 08025
Actively Recruiting
77
EBA Centelles ( Site 0600)
Barcelona, Spain, 08540
Active, Not Recruiting
78
Hacettepe Universite Hastaneleri ( Site 0700)
Sıhhiye, Ankara, Turkey (Türkiye), 06230
Active, Not Recruiting
79
Ufuk University Dr.Ridvan Ege Hospital ( Site 0709)
Ankara, Turkey (Türkiye), 06520
Active, Not Recruiting
80
Eskisehir Osmangazi University ( Site 0705)
Eskişehir, Turkey (Türkiye), 26480
Active, Not Recruiting
81
Istanbul Universitesi - Cerrahpasa Kardiyoloji Enstitusu ( Site 0703)
Istanbul, Turkey (Türkiye), 34080
Active, Not Recruiting
82
Ege Universitesi Hastanesi ( Site 0708)
Izmir, Turkey (Türkiye), 35080
Active, Not Recruiting
83
Erciyes Universitesi Tıp Fakultesi Hastaneleri ( Site 0701)
Kayseri, Turkey (Türkiye), 38030
Active, Not Recruiting
84
İnönü Üniversitesi Turgut Özal Tıp Merkezi ( Site 0702)
Malatya, Turkey (Türkiye), 44280
Active, Not Recruiting
85
Velocity Clinical Research, Bristol ( Site 0803)
Bristol, Bristol, City of, United Kingdom, BS8 2RA
Active, Not Recruiting
86
West Walk Surgery ( Site 0801)
Yate, Gloucestershire, United Kingdom, BS37 4AX
Active, Not Recruiting
87
Velocity Clinical Research Havering ( Site 0804)
London, Havering, United Kingdom, RM1 3PJ
Active, Not Recruiting
88
William Harvey Heart Centre ( Site 0800)
London, London, City of, United Kingdom, EC1M 6BQ
Active, Not Recruiting
89
Lakeside Surgery ( Site 0802)
Corby, Northamptonshire, United Kingdom, NN17 2UR
Active, Not Recruiting
Research Team
T
Toll Free Number
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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