Trial · NCT03409744
Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia
NCT03409744, Phase 3, Completed, Regeneron Pharmaceuticals; results first posted 2024-04-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia. Trials, record NCT03409744. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03409744
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia
- NCT number
- NCT03409744
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 116 participants, actual
- Lead sponsor
- Regeneron Pharmaceuticals
- Conditions
- Homozygous Familial Hypercholesterolemia
- Interventions
- evinacumab
- First posted
- 2018-01-24
- Last updated
- 2025-04-08
- Other registries' IDs
- eudract:2017-003170-13
- Results first posted
- 2024-04-30
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Up to Week 216 | Up to 216 weeks | The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment. |
| Secondary | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) Over Time | Up to 120 weeks | The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment. |
| Secondary | Absolute Change in LDL-C Over Time | Up to 120 weeks | The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment. |
| Secondary | Percent Change in Apolipoprotein B (Apo B) Over Time | Up to 120 weeks | The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment. |
| Secondary | Absolute Change in Apo B Over Time | Up to 120 weeks | The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment. |
| Secondary | Percent Change in Non-High-Density Lipoprotein Cholesterol (HDL-C) Over Time | Up to 120 weeks | The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment. |
| Secondary | Absolute Change in Non-HDL-C Over Time | Up to 120 weeks | The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment. |
| Secondary | Percent Change in Total Cholesterol (TC) Over Time | Up to 120 weeks | The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment. |
| Secondary | Absolute Change in TC Over Time | Up to 120 weeks | The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment. |
| Secondary | Percent Change in Triglycerides (TGs) Over Time | Up to 120 weeks | The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Up to Week 216 | Up to 216 weeks | Number of participants | NUMBER | |
| SECONDARY | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) Over Time | Up to 120 weeks | Here 'n' = number of evaluable participants at the specified timepoint | Percentage of change | MEAN |
| SECONDARY | Absolute Change in LDL-C Over Time | Up to 120 weeks | Here 'n' = number of evaluable participants at the specified timepoint | mg/dL | MEAN |
| SECONDARY | Percent Change in Apolipoprotein B (Apo B) Over Time | Up to 120 weeks | Here 'n' = number of evaluable participants at the specified timepoint | Percentage of change | MEAN |
| SECONDARY | Absolute Change in Apo B Over Time | Up to 120 weeks | Here 'n' = number of evaluable participants at the specified timepoint | mg/dL | MEAN |
| SECONDARY | Percent Change in Non-High-Density Lipoprotein Cholesterol (HDL-C) Over Time | Up to 120 weeks | Here 'n' = number of evaluable participants at the specified timepoint | Percentage of change | MEAN |
| SECONDARY | Absolute Change in Non-HDL-C Over Time | Up to 120 weeks | Here 'n' = number of evaluable participants at the specified timepoint | mg/dL | MEAN |
| SECONDARY | Percent Change in Total Cholesterol (TC) Over Time | Up to 120 weeks | Here 'n' = number of evaluable participants at the specified timepoint | Percentage of change | MEAN |
| SECONDARY | Absolute Change in TC Over Time | Up to 120 weeks | Here 'n' = number of evaluable participants at the specified timepoint | mg/dL | MEAN |
| SECONDARY | Percent Change in Triglycerides (TGs) Over Time | Up to 120 weeks | Here 'n' = number of evaluable participants at the specified timepoint | Percentage of change | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group62
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Up to Week 216 | Overall Study Total Evinacumab | Participants with any TEAE | 93 | Number of participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Up to Week 216 | Overall Study Total Evinacumab | Participants with at least one serious TEAE | 27 | Number of participants | |
| Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) Over Time | Overall Study Total Evinacumab | Week 8 | -46.45 | Standard Deviation 35.504 | Percentage of change |
| Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) Over Time | Overall Study Total Evinacumab | Week 24 | -43.64 | Standard Deviation 37.606 | Percentage of change |
| Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) Over Time | Overall Study Total Evinacumab | Week 48 | -43.88 | Standard Deviation 36.037 | Percentage of change |
| Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) Over Time | Overall Study Total Evinacumab | Week 72 | -45.17 | Standard Deviation 31.571 | Percentage of change |
| Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) Over Time | Overall Study Total Evinacumab | Week 96 | -38.00 | Standard Deviation 52.859 | Percentage of change |
| Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) Over Time | Overall Study Total Evinacumab | Week 120 | -33.10 | Standard Deviation 65.888 | Percentage of change |
| Absolute Change in LDL-C Over Time | Overall Study Total Evinacumab | Week 8 | -142.1 | Standard Deviation 114.61 | mg/dL |
| Absolute Change in LDL-C Over Time | Overall Study Total Evinacumab | Week 24 | -132.0 | Standard Deviation 124.37 | mg/dL |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Total Evinacumab | 116 | |
| Overall Study | COMPLETED | Total Evinacumab | 106 | |
| Overall Study | NOT COMPLETED | Total Evinacumab | 10 |
Source ClinicalTrials.gov
Adverse events60
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Overall | 23 | 116 | 42 |
| other | COVID-19 | Infections and infestations | Overall | 19 | 116 | 20 |
| other | Gastroenteritis | Infections and infestations | Overall | 10 | 116 | 11 |
| other | Urinary tract infection | Infections and infestations | Overall | 10 | 116 | 16 |
| other | Upper respiratory tract infection | Infections and infestations | Overall | 9 | 116 | 14 |
| other | Nausea | Gastrointestinal disorders | Overall | 14 | 116 | 17 |
| other | Diarrhoea | Gastrointestinal disorders | Overall | 10 | 116 | 21 |
| other | Abdominal pain | Gastrointestinal disorders | Overall | 7 | 116 | 10 |
| other | Toothache | Gastrointestinal disorders | Overall | 7 | 116 | 10 |
| other | Vomiting | Gastrointestinal disorders | Overall | 7 | 116 | 11 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Overall | 2 | 116 |
| Total, other adverse events | Overall | 79 | 116 |
| Total, serious adverse events | Overall | 27 | 116 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03409744
GET https://conductscience.org/api/trials/v1/NCT03409744/results?page=2