A Clinical Study of Enlicitide in Participants With High Cholesterol (MK-0616-037)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07216482
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Hyperlipidemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Enlicitide — DRUG
    Oral Tablet
  • Rosuvastatin — DRUG
    Oral Capsule
  • Placebo for Enlicitide — DRUG
    Oral Tablet
  • Placebo for Rosuvastatin — DRUG
    Oral Capsule

Study Details

Researchers designed a study medicine called enlicitide to lower low-density lipoprotein cholesterol (LDL-C). In this study, researchers want to learn about giving enlicitide with another medicine called rosuvastatin. Rosuvastatin is a standard (usual) treatment to lower LDL-C. The goal of this study is to learn if enlicitide given with rosuvastatin works better than placebo on lowering LDL-C in a person's blood. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of a study medicine.

Key Dates

Start date
Nov 11, 2025
Status verified
Jun 2026
Primary completion
Dec 2, 2026
Completion
Mar 1, 2027

Study Design

Enrollment
975 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Enlicitide
    Participants will receive enlicitide and a rosuvastatin-matching placebo. Both will be delivered orally once daily (QD) for up to 12 weeks.
  • Experimental: Enlicitide + Rosuvastatin
    Participants will receive enlicitide and rosuvastatin. Both will be delivered orally QD for up to 12 weeks.
  • Active Comparator: Rosuvastatin
    Participants will receive rosuvastatin and an enlicitide-matching placebo. Both will be delivered orally QD for up to 12 weeks.
  • Placebo Comparator: Placebo
    Participants will receive an enlicitide-matching placebo and a rosuvastatin-matching placebo. Placebos will be delivered orally QD for up to 12 weeks.

Primary Outcome Measure

Mean Percent Change from Baseline in LDL-C at Week 8 (Enlicitide + Rosuvastatin Versus Placebo) [ Time Frame: Baseline and Week 8 ]

Central Contacts

Locations (35)

FacilityCityStateZIPSite coordinators
Central Research Associates ( Site 0009)BirminghamAlabama35205
Study Coordinator
205-327-1077
G&L Research ( Site 0024)FoleyAlabama36535
Study Coordinator
251-943-2980
Synexus Clinical Research US, Inc. - Phoenix Central ( Site 0030)PhoenixArizona85020-
Alliance for Multispecialty Research LLC ( Site 0049)TempeArizona85281-
Chemidox Clinical Trials ( Site 0008)LancasterCalifornia93534
Study Coordinator
833-324-3643
Clinical Trials Research ( Site 0036)SacramentoCalifornia95821
Study Coordinator
916-487-8230
Legacy Clinical Trials ( Site 0044)Colorado SpringsColorado80909
Study Coordinator
719-387-7572
Alliance for Multispecialty Research, LLC ( Site 0040)Fort MyersFlorida33912-
Soffer Health Institute ( Site 0046)HollywoodFlorida33020
Study Coordinator
305-792-0555
East Coast Institute for Research ( Site 0041)Lake CityFlorida32055-
Inpatient Research Clinic ( Site 0017)Miami LakesFlorida33014-
Clinical Research Trials of Florida ( Site 0001)TampaFlorida33607-
Clinical Site Partners LLC, dba CSP Orlando ( Site 0014)Winter ParkFlorida32789
Study Coordinator
407-740-8078
Great Lakes Clinical Trials - Ravenswood ( Site 0018)ChicagoIllinois60640-
Trialmed ( Site 0026)ChicagoIllinois60602-
Midwest Institute For Clinical Research ( Site 0033)IndianapolisIndiana46260-5310-
Alliance for Multispecialty Research, LLC ( Site 0048)NewtonKansas67114-
Cotton O'Neil Clinical Research Center ( Site 0006)TopekaKansas66606-
Monroe Biomedical Research ( Site 0004)LouisvilleKentucky40213
Study Coordinator
502-515-5672
Jubilee Clinical Research ( Site 0031)Las VegasNevada89106
Study Coordinator
702-631-5000
Cardiovascular Associates of the Delaware Valley ( Site 0035)ElmerNew Jersey08318-
New Mexico Clinical Research & Osteoporosis Center, Inc. ( Site 0027)AlbuquerqueNew Mexico87106-4725-
Alliance for Multispecialty Research, LLC - Norman ( Site 0043)NormanOklahoma73069-
Cardiology Consultants of Philadelphia Yardley ( Site 0016)YardleyPennsylvania19067-
Provecta Research Network LLC ( Site 0022)HoustonTexas77027
Study Coordinator
346-735-8990
Permian Research Foundation ( Site 0005)OdessaTexas79761-
LinQ Research ( Site 0025)PearlandTexas77584-
Clinical Trials of Texas, Inc. ( Site 0010)San AntonioTexas78229
Study Coordinator
210-949-0122
Stone Oak, LLC dba Discovery Clinical Trials (DCT) ( Site 0021)San AntonioTexas78258-
LinQ Research - Tomball ( Site 0047)TomballTexas77375-
Conquest Research ( Site 0045)ArlingtonVirginia22205-
Manassas Clinical Research Center ( Site 0002)ManassasVirginia20110-
Health Research of Hampton Roads, Inc. ( Site 0013)Newport NewsVirginia23606-
National Clinical Research, Inc ( Site 0028)RichmondVirginia23294
Study Coordinator
804-755-2300
Rainier Clinical Research ( Site 0023)RentonWashington98057-

Find similar trials in Birmingham, AL

By research site
Central Research Associates· Birmingham, ALG&L Research· Foley, ALSynexus Clinical Research US, Inc. - Phoenix Central· Phoenix, AZAlliance for Multispecialty Research LLC· Tempe, AZChemidox Clinical Trials· Lancaster, CAClinical Trials Research· Sacramento, CA

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