Trial · NCT02265952
Study of REGN1500 in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
NCT02265952, Phase 2, Completed, Regeneron Pharmaceuticals; results first posted 2019-12-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of REGN1500 in Participants With Homozygous Familial Hypercholesterolemia (HoFH). Trials, record NCT02265952. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02265952
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of REGN1500 in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
- NCT number
- NCT02265952
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- Regeneron Pharmaceuticals
- Conditions
- Homozygous Familial Hypercholesterolemia
- Interventions
- REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
- First posted
- 2014-10-16
- Last updated
- 2019-12-09
- Other registries' IDs
- eudract:2016-000411-32
- Results first posted
- 2019-12-09
- Limitations and caveats
At the time patients completed the main study, the open-label extension (OLE) study was not yet open to enrollment. Therefore, there was a lag of between 168 days to 586 days between the end of the main study and the start of the OLE study.
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) to Week 4 in the Main Study Period | Baseline (Week 0) up to Week 4 | Percent change was reported for low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 4. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the safety analysis set (SAF) who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. |
| Secondary | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) to Week 4 in the Main Study Period | Baseline (Week 0) up to Week 4 | Absolute change in low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 4 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. |
| Secondary | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Week 2 to Week 4 in the Main Study Period | Week 2 to Week 4 | Absolute change in low-density lipoprotein cholesterol (LDL-C) from week 2 to week 4 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. |
| Secondary | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Week 2 to Week 4 in the Main Study Period | Week 2 to Week 4 | Percent change was reported in low-density lipoprotein cholesterol (LDL-C) from week 2 to week 4. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. |
| Secondary | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Baseline (Week 0) up to Week 26 | Absolute change was reported in low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 26. The efficacy analysis set included all participants in the safety analysis set (SAF) who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. |
| Secondary | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Baseline (Week 0) up to Week 26 | Percent change was reported in low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 26. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. |
| Secondary | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Baseline (Week 26) up to Week 214 | Absolute change in low-density lipoprotein cholesterol (LDL-C) from baseline (week 26) up to week 214 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study) |
| Secondary | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Baseline (Week 26) up to Week 214 | Percent change was reported in low-density lipoprotein cholesterol (LDL-C) from baseline (week 26) to week 214 in the OLE period. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had at least 1 post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study) |
| Secondary | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Baseline (Week 0) up to Week 26 | Absolute change was reported for Apo B, Non-HDL-C, Total-C, and Lp(a) from baseline (week 0) up to Week 26. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. |
| Secondary | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Baseline (Week 0) up to Week 26 | Percent change was reported for Apo B, Non-HDL-C, Total-C, and Lp(a) from baseline (week 0) up to week 26. Apo B, Non-HDL-C, Total-C, and Lp(a) were measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) to Week 4 in the Main Study Period | Baseline (Week 0) up to Week 4 | mg/dL | MEAN | |
| PRIMARY | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) to Week 4 in the Main Study Period | Baseline (Week 0) up to Week 4 | Percent Change | MEAN | |
| SECONDARY | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Week 2 to Week 4 in the Main Study Period | Week 2 to Week 4 | Milligram per Deciliter (mg/dL) | MEAN | |
| SECONDARY | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Week 2 to Week 4 in the Main Study Period | Week 2 to Week 4 | Percent Change | MEAN | |
| SECONDARY | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Baseline (Week 0) up to Week 26 | n = Number of participants who were evaluable for this endpoint at a given time point. | mg/dL | MEAN |
| SECONDARY | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Baseline (Week 0) up to Week 26 | n = Number of participants who were evaluable for this endpoint at a given time point. | Percent Change | MEAN |
| SECONDARY | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Baseline (Week 26) up to Week 214 | n = Number of participants who were evaluable for this endpoint at a given time point. | mg/dL | MEAN |
| SECONDARY | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Baseline (Week 26) up to Week 214 | n = Number of participants who were evaluable for this endpoint at a given time point. | Percent Change | MEAN |
| SECONDARY | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Baseline (Week 0) up to Week 26 | n = Number of participants who were evaluable for this endpoint at a given time point. | mg/dL | MEAN |
| SECONDARY | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Baseline (Week 0) up to Week 26 | n = Number of participants who were evaluable for this endpoint at a given time point. | Percent Change | MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group632
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) to Week 4 in the Main Study Period | REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | -157.34 | Standard Deviation 89.590 | mg/dL | |
| Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) to Week 4 in the Main Study Period | REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | -49.17 | Standard Deviation 23.136 | Percent Change | |
| Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Week 2 to Week 4 in the Main Study Period | REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | -63.63 | Standard Deviation 50.970 | Milligram per Deciliter (mg/dL) | |
| Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Week 2 to Week 4 in the Main Study Period | REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | -30.05 | Standard Deviation 18.503 | Percent Change | |
| Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Change at Day 4 (n= 9) | -39.60 | Standard Deviation 41.677 | mg/dL |
| Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Change at Week 1 (n= 9) | -67.59 | Standard Deviation 46.041 | mg/dL |
| Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Change at Week 2 (n= 9) | -93.71 | Standard Deviation 86.504 | mg/dL |
| Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Change at Week 3 (n= 9) | -129.97 | Standard Deviation 90.533 | mg/dL |
| Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Change at Week 4 (n= 9) | -157.34 | Standard Deviation 89.590 | mg/dL |
| Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Change at Week 5 (n= 8) | -179.18 | Standard Deviation 101.260 | mg/dL |
1 to 10 of 632Source ClinicalTrials.gov
See all 632 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Main Study Period | STARTED | REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | 9 | |
| Main Study Period | STARTED | REGN1500 300 mg SC/20 mg/kg IV | 0 | |
| Main Study Period | COMPLETED | REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | 9 | |
| Main Study Period | COMPLETED | REGN1500 300 mg SC/20 mg/kg IV | 0 | |
| Main Study Period | NOT COMPLETED | REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | 0 | |
| Main Study Period | NOT COMPLETED | REGN1500 300 mg SC/20 mg/kg IV | 0 | |
| Open Label Extension (OLE) Period | STARTED | REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | 0 | |
| Open Label Extension (OLE) Period | STARTED | REGN1500 300 mg SC/20 mg/kg IV | 8 | |
| Open Label Extension (OLE) Period | COMPLETED | REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | 0 | |
| Open Label Extension (OLE) Period | COMPLETED | REGN1500 300 mg SC/20 mg/kg IV | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events124
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 | Anaemia | Blood and lymphatic system disorders | Main Study Period: REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | 1 | 9 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | OLE Period: REGN1500 300 mg SC/20 mg/kg IV | 1 | 8 | 1 |
| other | Corneal opacity | Eye disorders | Main Study Period: REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | 1 | 9 | 1 |
| other | Corneal opacity | Eye disorders | OLE Period: REGN1500 300 mg SC/20 mg/kg IV | 0 | 8 | 0 |
| other | Eye inflammation | Eye disorders | Main Study Period: REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | 0 | 9 | 0 |
| other | Eye inflammation | Eye disorders | OLE Period: REGN1500 300 mg SC/20 mg/kg IV | 1 | 8 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Main Study Period: REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | 0 | 9 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | OLE Period: REGN1500 300 mg SC/20 mg/kg IV | 1 | 8 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Main Study Period: REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | 1 | 9 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | OLE Period: REGN1500 300 mg SC/20 mg/kg IV | 4 | 8 | 6 |
1 to 10 of 124Source ClinicalTrials.gov
See all 124 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Main Study Period: REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | 0 | 9 |
| Total, all-cause mortality | OLE Period: REGN1500 300 mg SC/20 mg/kg IV | 0 | 8 |
| Total, other adverse events | Main Study Period: REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | 9 | 9 |
| Total, other adverse events | OLE Period: REGN1500 300 mg SC/20 mg/kg IV | 8 | 8 |
| Total, serious adverse events | Main Study Period: REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | 1 | 9 |
| Total, serious adverse events | OLE Period: REGN1500 300 mg SC/20 mg/kg IV | 2 | 8 |
Source ClinicalTrials.gov
Papers2
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Main Study Period: REGN1500 250 mg SC/15 mg/kg IV/450 mg SC vs OLE Period: REGN1500 300 mg SC/20 mg/kg IV: deaths from any cause | Trial comparisons |
| Main Study Period: REGN1500 250 mg SC/15 mg/kg IV/450 mg SC vs OLE Period: REGN1500 300 mg SC/20 mg/kg IV: serious adverse events | Trial comparisons |
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/NCT02265952
GET https://conductscience.org/api/trials/v1/NCT02265952/registered?page=2