Trial · NCT03175367
Study of Evinacumab (REGN1500) in Participants With Persistent Hypercholesterolemia
NCT03175367, Phase 2, Completed, Regeneron Pharmaceuticals; results first posted 2023-02-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Evinacumab (REGN1500) in Participants With Persistent Hypercholesterolemia. Trials, record NCT03175367. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03175367
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Evinacumab (REGN1500) in Participants With Persistent Hypercholesterolemia
- NCT number
- NCT03175367
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 272 participants, actual
- Lead sponsor
- Regeneron Pharmaceuticals
- Conditions
- Hypercholesterolemia
- Interventions
- Evinacumab, Matching placebo, Background Lipid Modifying Therapy (LMT)
- First posted
- 2017-06-05
- Last updated
- 2023-02-10
- Other registries' IDs
- eudract:2017-001508-31
- Results first posted
- 2023-02-10
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 16 (Intent-to-Treat [ITT] Estimand) | Baseline and Week 16 | |
| Secondary | Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16 (ITT Estimand) | Baseline and Week 16 | |
| Secondary | Percent Change From Baseline in Apo B at Week 24 (ITT Estimand) | Baseline and Week 24 | |
| Secondary | Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16 (ITT Estimand) | Baseline and Week 16 | |
| Secondary | Percent Change From Baseline in Non-HDL-C at Week 24 (ITT Estimand) | Baseline and Week 24 | |
| Secondary | Percentage of Participants With >= 30% Reduction in Calculated LDL-C at Week 16 (ITT Estimand) | Week 16 | |
| Secondary | Percentage of Participants With >= 50% Reduction in Calculated LDL-C at Week 16 (ITT Estimand) | Week 16 | |
| Secondary | Percentage of Participants With Calculated LDL-C < 50 mg/dL (1.30 mmol/L) at Week 16 (ITT Estimand) | Week 16 | Percentage of Participants with Calculated LDL-C \< 50 milligrams/deciliter (mg/dL) \[1.30 Millimoles per liter (mmol/L)\] at Week 16 (ITT Estimand) |
| Secondary | Percent Change From Baseline in Calculated LDL-C at Week 24 (ITT Estimand) | Baseline and Week 24 | |
| Secondary | Percent Change From Baseline in Total Cholesterol (TC) at Week 16 (ITT Estimand) | Baseline and Week 16 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 16 (Intent-to-Treat [ITT] Estimand) | Baseline and Week 16 | Percent Change | LEAST_SQUARES_MEAN | |
| SECONDARY | Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16 (ITT Estimand) | Baseline and Week 16 | Percent Change | LEAST_SQUARES_MEAN | |
| SECONDARY | Percent Change From Baseline in Apo B at Week 24 (ITT Estimand) | Baseline and Week 24 | Percent Change | LEAST_SQUARES_MEAN | |
| SECONDARY | Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16 (ITT Estimand) | Baseline and Week 16 | Percent Change | LEAST_SQUARES_MEAN | |
| SECONDARY | Percent Change From Baseline in Non-HDL-C at Week 24 (ITT Estimand) | Baseline and Week 24 | Percent Change | LEAST_SQUARES_MEAN | |
| SECONDARY | Percentage of Participants With >= 30% Reduction in Calculated LDL-C at Week 16 (ITT Estimand) | Week 16 | Percentage of Participants | NUMBER | |
| SECONDARY | Percentage of Participants With >= 50% Reduction in Calculated LDL-C at Week 16 (ITT Estimand) | Week 16 | Percentage of Participants | NUMBER | |
| SECONDARY | Percentage of Participants With Calculated LDL-C < 50 mg/dL (1.30 mmol/L) at Week 16 (ITT Estimand) | Week 16 | Percentage of Participants | NUMBER | |
| SECONDARY | Percent Change From Baseline in Calculated LDL-C at Week 24 (ITT Estimand) | Baseline and Week 24 | Percent Change | LEAST_SQUARES_MEAN | |
| SECONDARY | Percent Change From Baseline in Total Cholesterol (TC) at Week 16 (ITT Estimand) | Baseline and Week 16 | Percent Change | LEAST_SQUARES_MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group81
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 16 (Intent-to-Treat [ITT] Estimand) | Group A: Placebo SC QW (DBTP) | 8.8 | Standard Error 6.4 | Percent Change | |
| Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 16 (Intent-to-Treat [ITT] Estimand) | Group A: Evinacumab 300 mg SC Q2W (DBTP) | -29.7 | Standard Error 6.4 | Percent Change | |
| Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 16 (Intent-to-Treat [ITT] Estimand) | Group A: Evinacumab 300 mg SC QW (DBTP) | -44.0 | Standard Error 6.3 | Percent Change | |
| Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 16 (Intent-to-Treat [ITT] Estimand) | Group A: Evinacumab 450 mg SC QW (DBTP) | -47.2 | Standard Error 6.2 | Percent Change | |
| Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 16 (Intent-to-Treat [ITT] Estimand) | Group B: Placebo IV Q4W (DBTP to OLTP) | 0.6 | Standard Error 6.6 | Percent Change | |
| Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 16 (Intent-to-Treat [ITT] Estimand) | Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP) | -23.5 | Standard Error 6.6 | Percent Change | |
| Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 16 (Intent-to-Treat [ITT] Estimand) | Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP) | -49.9 | Standard Error 6.1 | Percent Change | |
| Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16 (ITT Estimand) | Group A: Placebo SC QW (DBTP) | 6.7 | Standard Error 5.1 | Percent Change | |
| Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16 (ITT Estimand) | Group A: Evinacumab 300 mg SC Q2W (DBTP) | -19.9 | Standard Error 5.1 | Percent Change | |
| Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16 (ITT Estimand) | Group A: Evinacumab 300 mg SC QW (DBTP) | -35.2 | Standard Error 5.1 | Percent Change |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 results by groupParticipant flow42
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Treatment Period (DBTP) | STARTED | Group A: Placebo SC QW (DBTP) | 39 | |
| Double-blind Treatment Period (DBTP) | STARTED | Group A: Evinacumab 300 mg SC Q2W (DBTP) | 39 | |
| Double-blind Treatment Period (DBTP) | STARTED | Group A: Evinacumab 300 mg SC QW (DBTP) | 42 | |
| Double-blind Treatment Period (DBTP) | STARTED | Group A: Evinacumab 450 mg SC QW (DBTP) | 40 | |
| Double-blind Treatment Period (DBTP) | STARTED | Group B: Placebo IV Q4W (DBTP to OLTP) | 33 | |
| Double-blind Treatment Period (DBTP) | STARTED | Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP) | 35 | |
| Double-blind Treatment Period (DBTP) | STARTED | Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP) | 38 | |
| Double-blind Treatment Period (DBTP) | COMPLETED | Group A: Placebo SC QW (DBTP) | 30 | |
| Double-blind Treatment Period (DBTP) | COMPLETED | Group A: Evinacumab 300 mg SC Q2W (DBTP) | 31 | |
| Double-blind Treatment Period (DBTP) | COMPLETED | Group A: Evinacumab 300 mg SC QW (DBTP) | 30 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 participant flowAdverse events940
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 | Myalgia | Musculoskeletal and connective tissue disorders | Group A: Placebo SC QW (DBTP) | 0 | 39 | 0 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Group A: Evinacumab 300 mg SC Q2W (DBTP) | 4 | 39 | 5 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Group A: Evinacumab 300 mg SC QW (DBTP) | 1 | 42 | 3 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Group A: Evinacumab 450 mg SC QW (DBTP) | 2 | 40 | 2 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Group B: Placebo IV Q4W (DBTP) | 4 | 33 | 5 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Group B: Evinacumab 5 mg/kg IV Q4W (DBTP) | 5 | 36 | 5 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Group B: Evinacumab 15 mg/kg IV Q4W (DBTP) | 2 | 37 | 2 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Group B: Placebo IV Q4W (OLTP) | 2 | 31 | 3 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Group B: Evinacumab 5 mg/kg IV Q4W (OLTP) | 1 | 32 | 1 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Group B: Evinacumab 15 mg/kg IV Q4W (OLTP) | 0 | 33 | 0 |
1 to 10 of 940Source ClinicalTrials.gov
See all 940 adverse eventsAdverse event totals30
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group A: Placebo SC QW (DBTP) | 0 | 39 |
| Total, all-cause mortality | Group A: Evinacumab 300 mg SC Q2W (DBTP) | 1 | 39 |
| Total, all-cause mortality | Group A: Evinacumab 300 mg SC QW (DBTP) | 1 | 42 |
| Total, all-cause mortality | Group A: Evinacumab 450 mg SC QW (DBTP) | 0 | 40 |
| Total, all-cause mortality | Group B: Placebo IV Q4W (DBTP) | 0 | 33 |
| Total, all-cause mortality | Group B: Evinacumab 5 mg/kg IV Q4W (DBTP) | 0 | 36 |
| Total, all-cause mortality | Group B: Evinacumab 15 mg/kg IV Q4W (DBTP) | 0 | 37 |
| Total, all-cause mortality | Group B: Placebo IV Q4W (OLTP) | 0 | 31 |
| Total, all-cause mortality | Group B: Evinacumab 5 mg/kg IV Q4W (OLTP) | 0 | 32 |
| Total, all-cause mortality | Group B: Evinacumab 15 mg/kg IV Q4W (OLTP) | 0 | 33 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT03175367
GET https://conductscience.org/api/trials/v1/NCT03175367/results?page=2