DrugEvidence

Diseases / Hypercholesterolemia

Hypercholesterolemia

Disease

Hypercholesterolemia is a lipid disorder characterized by elevated cholesterol levels, especially LDL cholesterol, in the blood. Persistent elevation contributes to atherosclerosis and increased risk of coronary heart disease and stroke. It can be primary (genetic) or secondary to lifestyle and other medical factors.

Trials
1127
Recruiting
49
Completed
860
With results
273

Last revised

Pipeline

Phase by status

PhaseRecruitingNot yetBy invitationActiveCompletedTerminatedWithdrawnSuspendedUnknownTotal
Early Phase 1 16 7
Phase 1 4177624 94
Phase 1/2 811 10
Phase 2 44107522 124
Phase 2/3 171 9
Phase 3 63252222223 265
Phase 4 5221099317 147
Not applicable 196310211127139 308
Unknown 1052511364117 163

Trials started per year

2021
10
2022
41
2023
34
2024
55
2025
30
2026
34
2027
2

Conditions studied, by phase

ConditionEarly Phase 1Phase 1Phase 1/2Phase 2Phase 2/3Phase 3Phase 4Not applicableUnknownTotal
Hypercholesterolemia 794101249265147308163 1127
Dyslipidemias 17122146121921 139
Hyperlipidemias 172047103411 139
Hypertension 6181687326 138
Cardiovascular Diseases 610116134537 128
Diabetes Mellitus 2131075620 99
Atherosclerosis 71723161117 82
Obesity 35314910 71
Hyperlipoproteinemia Type II 12142244910 57
Coronary Disease 13208715 54

Most active sponsors

#SponsorTrialsPhase 3
1Organon and Co8756
2AstraZeneca5924
3Sanofi3722
4Amgen3524
5National Heart, Lung, and Blood Institute (NHLBI)305
6Merck Sharp & Dohme LLC2715
7Novartis Pharmaceuticals2310
8Pfizer172
9Pfizer's Upjohn has merged with Mylan to form Viatris Inc.175
10Esperion Therapeutics, Inc.156

Most studied interventions

#InterventionTrials
1Ezetimibe154
2Atorvastatin134
3Rosuvastatin Calcium86
4Simvastatin84
5alirocumab49
6evolocumab43
78-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid25
8Hydroxymethylglutaryl-CoA Reductase Inhibitors25
9Pravastatin23
10Ezetimibe, Simvastatin Drug Combination22

Evidence

Results reported
31.7%273 of 860 completed
Published
15.5%133 of 860 completed
Primary endpoint met
91%352 of 387 analyses
Median months to report
16

Documents disclosed

Protocol available
96
Statistical analysis plan
93
PubMed citations
219

Trial profile

Median enrollment
126
Median duration
17.4months
Countries
79
Study sites
11926

Who is enrolled

Adults
1095
Children
99
Older adults
997
Healthy volunteers
342

Median enrollment by phase

Early Phase 1
67
Phase 1
41
Phase 1/2
50
Phase 2
95
Phase 2/3
80
Phase 3
414
Phase 4
90
Not applicable
70
Unknown
810

Where trials run

United States
375
Canada
122
Italy
81
Netherlands
81
Germany
80
United Kingdom
78
Spain
77
South Korea
68
France
64
China
52

Busiest cities

#CityCountryTrials
1CincinnatiUnited States97
2JacksonvilleUnited States70
3IndianapolisUnited States64
4ChicagoUnited States63
5HoustonUnited States63
6RichmondUnited States63
7MiamiUnited States55
8DallasUnited States52
9St LouisUnited States52
10AmsterdamNetherlands51

Terminations

Terminated
61
Withdrawn
20
Suspended
2
Stopped for recruitment
1.5%17 of 1127 trials

Stated reasons

Other / unclear
40
Recruitment
17
Lack of efficacy
10
Funding
6
COVID-19
4
Business decision
3
Regulatory
2
Safety
1

Reasons are grouped from the sponsor's own wording with a rule-based classifier; the original text is shown below.

Recently stopped

TrialStatusStated reasonStopped
NCT04031469 Suspended Suspended Administrative 2030-12-10
NCT04148339 Withdrawn Withdrawn Company focus shifted 2030-07-31
NCT05393882 Withdrawn Withdrawn Insufficient funding 2027-12-31
NCT05704439 Withdrawn Withdrawn not funded 2027-01-31
NCT05720156 Withdrawn Withdrawn Lack of Feasibility 2026-03-31
NCT05834673 Terminated Terminated Loss of strategic interest by the funding party. The participants' recruitment rate failed to meet the target within the pre-specified recruitment windows. 2024-12-19
NCT04314167 Terminated Terminated poor recruitment 2024-03-01
NCT02818283 Terminated Terminated lack of recruitment and funding 2023-10-31
NCT05594979 Terminated Terminated The recruitment period has come to an end and will not be renewed due to insufficient recruitment. 2023-09-27
NCT04277741 Withdrawn Withdrawn PI departure from university 2023-06-30

Trial records