ENLICITIDE CHLORIDE for Hyperlipidemia

Inclusion criteria

• {"criterion_text":"-Has either not received lipid-lowering therapy (LLT) or has not received certain LLTs within a specified time period prior to the study.\n-Is an individual of any sex/gender, from 18 years to 64 years age inclusive."}

Exclusion criteria

• {"criterion_text":"-Has a history of homozygous familial hypercholesterolemia (FH), compound heterozygous FH, or double heterozygous FH.\n-Had a heart failure hospitalization within 3 months before Screening.\n-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.\n-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.\n-Has active or chronic hepatobiliary or hepatic disease.\n-Has known human immunodeficiency virus (HIV) infection.\n-Is undergoing or previously underwent an LDL-C apheresis program within 3 months before Screening or plans to initiate an LDL-C apheresis program.\n-Has received any medication that may interact with rosuvastatin within 5 half-lives prior to Screening or is planning to initiate such treatment."}

Primary endpoints

• {"endpoint_text":"-Mean Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8 (Enlicitide + Rosuvastatin Versus Placebo)","definition_or_measurement_approach":"Mean percent change from baseline in LDL-C at Week 8 comparing Enlicitide + Rosuvastatin versus Placebo (analysis of mean percent change from baseline in LDL-C at Week 8)."}

Secondary endpoints

• {"endpoint_text":"-Mean Percent Change from Baseline in LDL-C at Week 8","definition_or_measurement_approach":"Mean percent change from baseline in LDL-C at Week 8."}
• {"endpoint_text":"-Mean Percent Change from Baseline in Apolipoprotein B (ApoB) at Week 8","definition_or_measurement_approach":"Mean percent change from baseline in ApoB at Week 8."}
• {"endpoint_text":"-Number of Participants with One or More Adverse Events (AEs)","definition_or_measurement_approach":"Count of participants reporting one or more adverse events during the study period."}
• {"endpoint_text":"-Number of Participants who Discontinue Study Drug Due to One or More AEs","definition_or_measurement_approach":"Count of participants who permanently discontinue study drug because of one or more adverse events."}
• {"endpoint_text":"-Mean Percent Change from Baseline in LDL-C at Week 12","definition_or_measurement_approach":"Mean percent change from baseline in LDL-C at Week 12."}
• {"endpoint_text":"-Mean Percent Change from Baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C) at Week 8","definition_or_measurement_approach":"Mean percent change from baseline in non-HDL-C at Week 8."}
• {"endpoint_text":"-Percent Change from Baseline in Lipoprotein (a) (Lp[a]) at Week 8","definition_or_measurement_approach":"Percent change from baseline in Lp(a) at Week 8."}
• {"endpoint_text":"-Percentage of Participants with LDL-C <70 mg/dL and ≥50% Reduction from Baseline at Week 8","definition_or_measurement_approach":"Proportion of participants achieving LDL-C <70 mg/dL and ≥50% reduction from baseline at Week 8."}
• {"endpoint_text":"-Percentage of Participants with LDL-C <55 mg/dL and ≥50% Reduction from Baseline at Week 8","definition_or_measurement_approach":"Proportion of participants achieving LDL-C <55 mg/dL and ≥50% reduction from baseline at Week 8."}

Hungary

Earliest CTIS Part Ii Submission Date

02-10-2025

Latest Decision Or Authorization Date

24-11-2025

Processing Time Days

53

Number Of Sites

5

Number Of Participants

60

Spain

Earliest CTIS Part Ii Submission Date

27-10-2025

Latest Decision Or Authorization Date

04-12-2025

Processing Time Days

38

Number Of Sites

3

Number Of Participants

50

Primary sponsor

Full Name

Merck Sharp & Dohme LLC

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Signant Health Global LLC

Responsibilities

sponsorDuties codes: 3

Name

Labcorp Central Laboratory Services SARL

Responsibilities

sponsorDuties codes: 4

Name

Parexel International Corp.

Responsibilities

EUB services (call center and medical services)

Third parties

• {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services); sponsorDuties code: 15","organisation_type":"Pharmaceutical company"}