Trial · NCT03452228
Safety and Efficacy Following Repeat-Dose of Evinacumab (Anti-ANGPTL3) in Patients With Severe Hypertriglyceridemia (sHTG) at Risk for Acute Pancreatitis
NCT03452228, Phase 2, Completed, Regeneron Pharmaceuticals; results first posted 2023-02-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Following Repeat-Dose of Evinacumab (Anti-ANGPTL3) in Patients With Severe Hypertriglyceridemia (sHTG) at Risk for Acute Pancreatitis. Trials, record NCT03452228. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03452228
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Following Repeat-Dose of Evinacumab (Anti-ANGPTL3) in Patients With Severe Hypertriglyceridemia (sHTG) at Risk for Acute Pancreatitis
- NCT number
- NCT03452228
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 52 participants, actual
- Lead sponsor
- Regeneron Pharmaceuticals
- Conditions
- Severe Hypertriglyceridemia (sHTG)
- Interventions
- evinacumab, Placebo
- First posted
- 2018-03-02
- Last updated
- 2023-02-16
- Other registries' IDs
- eudract:2016-003307-62
- Results first posted
- 2023-02-16
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Fasting Triglycerides (TG) Level Following 12 Weeks of Repeated IV Doses of Evinacumab in Actual Cohort 3 Participants | Participants randomized to evinacumab: Week 0 corresponds to Baseline and 12 weeks treatment corresponds to Week 12 of the DBTP; Participants randomized to placebo: Week 12 corresponds to Baseline and 12 weeks treatment corresponds to Week 24 of the SBTP | For participants randomized to evinacumab treatment group, baseline (Week 0) TG was defined as the geometric mean of all available TG results at day -28, day -14 and week 0; for participants randomized to placebo treatment group, baseline (Week 12) TG was defined as the geometric mean of all available TG results at weeks 6, 8, and 12. |
| Secondary | Percent Change From Baseline in Fasting TG Level Following 2 to 24 Weeks of Repeated IV Doses of Evinacumab Overall Group | DBTP: Baseline, Weeks 2, 4, 6, 8, 12; SBTP: Weeks 16, 20, and 24 | Percent change from baseline in fasting TG level following 2 to 24 weeks of repeated IV doses of evinacumab overall group during DBTP and SBTP was reported. |
| Secondary | Percent Change From Baseline in Fasting TG Level Following 2 to 24 Weeks of Repeated IV Doses of Evinacumab in Actual Cohorts 1, 2, and 3 | Weeks 2, 4, 6, 8, 12, 16, 20, and 24 | Percent change from baseline in fasting TG level following 2 to 24 weeks of repeated IV doses of evinacumab in actual cohorts 1, 2, and 3 participants were reported. |
| Secondary | Change From Baseline in Total Score of Participants Reported Abdominal and Gastrointestinal (GI) Symptoms Using Hypertriglyceridemia and Acute Pancreatitis Symptom Scale (HAP-SS) | Baseline, Week 12 (DBTP), Week 24 (SBTP) | HAP-SS: 19-item measure of symptoms with a 24-hour recall period. 4 pain items were captured on 0-10-point severity NRS, each scored 0 (No pain) to 10 (Worst possible pain), while 15 non-pain items captured on 5-point frequency Likert scale, each scored from 1 (None of the time) to 5 (All of the time). Pain domain 4 items: stomach pain average, worst stomach pain, worst back pain, stomach pain after eating (score range: 0 to 40). Abdominal symptoms domain 6 items: bloated, nausea, vomiting, passed excessive gas, diarrhea, light-colored or greasy stool (score range: 6 to 30). Physical symptoms domain 5 items: fever, insomnia, excessive sweating, dizziness, racing heart rate (score range 5 to 25). Other symptoms domain 4 items: fatigue, loss of appetite, hungry after eating, felt full after eating a small amount (score range 4 to 20). All items were transformed on to total score ranges from 0 (no symptoms) to 100 (severe symptoms). Negative change indicates better condition. |
| Secondary | Change From Baseline in Total Score of Participants Reported Dietary Behavior Questionnaire (HAP-DB) | Baseline, Week 12 (DBTP), Week 24 (SBTP) | Dietary habits and impact were measured by the Hypertriglyceridemia and Acute Pancreatitis Dietary Behavior (HAP-DB) questionnaire, a 6- item measure of dietary behavior that had a 24-hour recall period using a 5-point frequency Likert scale (1= None of the time to 5= All of the time) and a dietary impact total score, ranging from 6 (no impact) to 30 (severe impact). The six HAP-DB items were: 1 -amount of food eaten), 2 -fatty or greasy food), 3 -carbohydrates), i4 (-sugar or sugary foods), 5 -alcohol intake), 6 -skipped meal). The total score was calculated as the sum of the six item scores and then transformed to a 0-100 score, where lower score indicates less of an issue with dietary behaviors. Transformed score = 100 \* (score - minimum possible score) / (maximum - minimum possible score). Change from baseline in total score of participants reported daily dietary habits and impact questionnaire during DBTP and SBTP was reported. |
| Secondary | DBTP: Change From Baseline in Degree of Pancreatic Injury/Inflammation Through 18F-2-Fluoro-2-Deoxy-D Glucose Positron Emission Tomography (18F-FDG-PET) Imaging Following 12 Weeks of Treatment With Evinacumab Assessed by 18F-FDG SUVmax and SUVmean | Participants randomized to evinacumab: Week 0 corresponds to Baseline and 12 weeks treatment corresponds to Week 12 of the DBTP; Participants randomized to placebo: Week 12 corresponds to Baseline and 12 weeks treatment corresponds to Week 24 of the SBTP | 18F-FDG-PET is a molecular imaging modality that has demonstrated high sensitivity in the in vivo detection of glycolytic tissues, including tumors and inflammatory foci. 18F-FDG PET has been applied in a clinical setting to the assessment of inflammation for a variety of indications, including auto immune pancreatitis, atherosclerosis and infection. 18F-FDG-PET was performed at baseline (placebo run-in period) and following 12 weeks of study treatment (double-blind treatment period) as a method to measure inflammation in the pancreas. Here, SUVmax was standardized uptake values maximum and SUVmean was mean standardized uptake values were reported. |
| Secondary | DBTP: Change From Baseline in Degree of Pancreatic Injury/Inflammation Through Diffusion Weighted-Magnetic Resonance Imaging (DW-MRI) Following 12 Weeks of Treatment With Evinacumab Assessed by Apparent Diffusion Coefficient (ADC) | Participants randomized to evinacumab: Week 0 corresponds to Baseline and 12 weeks treatment corresponds to Week 12 of the DBTP; Participants randomized to placebo: Week 12 corresponds to Baseline and 12 weeks treatment corresponds to Week 24 of the SBTP | In DW-MRI the random diffusion of water molecules occurring within intracellular, extracellular and intravascular spaces were measured, enabling detection of macroscopic soft tissue pathology such as edema, necrosis and fibrosis. The ADC was a principal metric quantified in DW-MRI experiments, where ADC values was mapped across a region of interest at a spatial resolution of \~3\*3\*5 cubic millimeter (mm\^3). Normal pancreas ADCs were considered as (1.77±0.32)\*103 square-millimeters per second (mm\^2/sec) while acute pancreatitis ADCs were (1.32±0.32)\* 103 mm\^2/sec showing a significant window for measuring projected inflammatory changes in pancreas. DW-MRI was performed at baseline (placebo run-in period) and following 12 weeks of study treatment (double-blind treatment period) as a method to measure inflammation in the pancreas. Change from baseline in degree of pancreatic injury/inflammation through DW-MRI following 12 weeks of treatment with evinacumab assessed by ADC was reported. |
| Secondary | SBTP: Change From Baseline to Degree of Pancreatic Injury/Inflammation Through DW-MRI Following 24 Weeks of Treatment With Evinacumab as Assessed by ADC | Baseline (Week 0 DBTP), Week 24 (SBTP) | In DW-MRI, the random diffusion of water molecules occurring within intracellular, extracellular and intravascular spaces were measured, enabling detection of macroscopic soft tissue pathology such as edema, necrosis and fibrosis. The ADC was a principal metric quantified in DW-MRI experiments, where ADC values was mapped across a region of interest at a spatial resolution of \~3\*3\*5 mm\^3. Normal pancreas ADCs were considered as (1.77±0.32)\*103 mm\^2/sec while acute pancreatitis ADCs are (1.32±0.32)\* 103 mm\^2/sec showing a significant window for measuring the projected inflammatory changes in the pancreas. Change from baseline to degree of pancreatic injury/inflammation through DW-MRI following 24 weeks of treatment with evinacumab assessed by ADC was reported. |
| Secondary | Total Evinacumab Concentration in Serum | Up to 44 weeks | Concentrations of total evinacumab in serum by time and DBTP treatment group reported |
| Secondary | Total Angiopoietin-like (ANGPTL3) Concentration in Serum | Up to 44 weeks | Concentrations of total ANGPTL3 in serum by time and DBTP treatment group reported |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
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 Fasting Triglycerides (TG) Level Following 12 Weeks of Repeated IV Doses of Evinacumab in Actual Cohort 3 Participants | Participants randomized to evinacumab: Week 0 corresponds to Baseline and 12 weeks treatment corresponds to Week 12 of the DBTP; Participants randomized to placebo: Week 12 corresponds to Baseline and 12 weeks treatment corresponds to Week 24 of the SBTP | The FAS included all randomized participants who received any double-blind study drug based on the treatment assigned (as randomized). Mixed-effect Model for Repeated Measures (MMRM) method assessed within-patient treatment comparisons (using an unstructured covariance matrix), while accounting for baseline TG, study visit, and baseline TG by study visit interaction. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Fasting TG Level Following 2 to 24 Weeks of Repeated IV Doses of Evinacumab Overall Group | DBTP: Baseline, Weeks 2, 4, 6, 8, 12; SBTP: Weeks 16, 20, and 24 | The FAS included all randomized participants who received any double-blind study drug based on the treatment assigned (as randomized). Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure for specified arm/period and number analyzed signifies to participants evaluable for this outcome at given timepoints. | Percent Change | MEAN |
| SECONDARY | Percent Change From Baseline in Fasting TG Level Following 2 to 24 Weeks of Repeated IV Doses of Evinacumab in Actual Cohorts 1, 2, and 3 | Weeks 2, 4, 6, 8, 12, 16, 20, and 24 | The FAS included all randomized participants who received any double-blind study drug based on the treatment assigned (as randomized). Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure for specified arm/period and number analyzed signifies to participants evaluable for this outcome at given timepoints. | Percent Change | MEDIAN |
| SECONDARY | Change From Baseline in Total Score of Participants Reported Abdominal and Gastrointestinal (GI) Symptoms Using Hypertriglyceridemia and Acute Pancreatitis Symptom Scale (HAP-SS) | Baseline, Week 12 (DBTP), Week 24 (SBTP) | Patient-reported outcomes (PRO) analysis set included all randomized participants who received any double-blind study treatment with a baseline and at least 1 non-missing post-baseline PRO evaluation. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure for specified arm/period. | Score on a Scale | MEAN |
| SECONDARY | Change From Baseline in Total Score of Participants Reported Dietary Behavior Questionnaire (HAP-DB) | Baseline, Week 12 (DBTP), Week 24 (SBTP) | PRO analysis set includes all randomized participants who received any double-blind study treatment with a baseline and at least 1 non-missing post-baseline PRO evaluation. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure for specified arm/period. | Score on a Scale | MEAN |
| SECONDARY | DBTP: Change From Baseline in Degree of Pancreatic Injury/Inflammation Through 18F-2-Fluoro-2-Deoxy-D Glucose Positron Emission Tomography (18F-FDG-PET) Imaging Following 12 Weeks of Treatment With Evinacumab Assessed by 18F-FDG SUVmax and SUVmean | Participants randomized to evinacumab: Week 0 corresponds to Baseline and 12 weeks treatment corresponds to Week 12 of the DBTP; Participants randomized to placebo: Week 12 corresponds to Baseline and 12 weeks treatment corresponds to Week 24 of the SBTP | PET analysis set included all randomized participants who received any double-blind study treatment with a baseline and a post-baseline (positron emission tomography) PET evaluation. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure for specified arm/period. | gram/milliliter (g/ml) | MEAN |
| SECONDARY | DBTP: Change From Baseline in Degree of Pancreatic Injury/Inflammation Through Diffusion Weighted-Magnetic Resonance Imaging (DW-MRI) Following 12 Weeks of Treatment With Evinacumab Assessed by Apparent Diffusion Coefficient (ADC) | Participants randomized to evinacumab: Week 0 corresponds to Baseline and 12 weeks treatment corresponds to Week 12 of the DBTP; Participants randomized to placebo: Week 12 corresponds to Baseline and 12 weeks treatment corresponds to Week 24 of the SBTP | Magnetic resonance imaging (MRI) analysis set included all randomized participants who received any double-blind study treatment with a baseline and at least 1 post-baseline MRI evaluation. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure for specified arm/period and number analyzed signifies to participants evaluable for this outcome at given timepoints. | Square-millimeters per second (mm^2/sec) | MEAN |
| SECONDARY | SBTP: Change From Baseline to Degree of Pancreatic Injury/Inflammation Through DW-MRI Following 24 Weeks of Treatment With Evinacumab as Assessed by ADC | Baseline (Week 0 DBTP), Week 24 (SBTP) | MRI analysis set included all randomized participants who received any double-blind study treatment with a baseline and at least 1 post-baseline MRI evaluation. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure for specified arm/period. | mm^2/sec | MEAN |
| SECONDARY | Total Evinacumab Concentration in Serum | Up to 44 weeks | Pharmacokinetic (PK) analysis set included all randomized participants who received any study drug and have at least 1 non-missing measurement of evinacumab concentration following the first dose of the study drug. Here, number analyzed signifies to participants evaluable for this outcome at given timepoints. | milligram per liter (mg/L) | MEAN |
| SECONDARY | Total Angiopoietin-like (ANGPTL3) Concentration in Serum | Up to 44 weeks | The total target analysis set is defined as all randomized participants who received any study drug and have at least 1 non-missing measurement of total ANGPTL3 concentration following the first dose of study drug. Here, number analyzed signifies to participants evaluable for this outcome at given timepoints. | mg/L | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group170
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 Fasting Triglycerides (TG) Level Following 12 Weeks of Repeated IV Doses of Evinacumab in Actual Cohort 3 Participants | Actual Cohort 3: DB Placebo/SB Evinacumab IV 15mg/kg Q4W | 19.2 | Standard Error 99.1 | Percent Change | |
| Percent Change From Baseline in Fasting Triglycerides (TG) Level Following 12 Weeks of Repeated IV Doses of Evinacumab in Actual Cohort 3 Participants | Actual Cohort 3: DB Evinacumab/SB Evinacumab IV 15mg/kg Q4W | -37.2 | Standard Error 42.9 | Percent Change | |
| Percent Change From Baseline in Fasting TG Level Following 2 to 24 Weeks of Repeated IV Doses of Evinacumab Overall Group | Placebo Q4W (DBTP) | Percent change at Week 2 | 1.99 | Standard Deviation 45.687 | Percent Change |
| Percent Change From Baseline in Fasting TG Level Following 2 to 24 Weeks of Repeated IV Doses of Evinacumab Overall Group | Evinacumab IV 15mg/kg Q4W (DBTP) | Percent change at Week 2 | -51.38 | Standard Deviation 33.160 | Percent Change |
| Percent Change From Baseline in Fasting TG Level Following 2 to 24 Weeks of Repeated IV Doses of Evinacumab Overall Group | Placebo Q4W (DBTP) | Percent change at Week 4 | -3.52 | Standard Deviation 41.029 | Percent Change |
| Percent Change From Baseline in Fasting TG Level Following 2 to 24 Weeks of Repeated IV Doses of Evinacumab Overall Group | Evinacumab IV 15mg/kg Q4W (DBTP) | Percent change at Week 4 | -43.70 | Standard Deviation 39.119 | Percent Change |
| Percent Change From Baseline in Fasting TG Level Following 2 to 24 Weeks of Repeated IV Doses of Evinacumab Overall Group | Placebo Q4W (DBTP) | Percent change at Week 6 | 92.56 | Standard Deviation 262.368 | Percent Change |
| Percent Change From Baseline in Fasting TG Level Following 2 to 24 Weeks of Repeated IV Doses of Evinacumab Overall Group | Evinacumab IV 15mg/kg Q4W (DBTP) | Percent change at Week 6 | -52.69 | Standard Deviation 40.214 | Percent Change |
| Percent Change From Baseline in Fasting TG Level Following 2 to 24 Weeks of Repeated IV Doses of Evinacumab Overall Group | Placebo Q4W (DBTP) | Percent change at Week 8 | 4.83 | Standard Deviation 38.941 | Percent Change |
| Percent Change From Baseline in Fasting TG Level Following 2 to 24 Weeks of Repeated IV Doses of Evinacumab Overall Group | Evinacumab IV 15mg/kg Q4W (DBTP) | Percent change at Week 8 | -32.86 | Standard Deviation 64.787 | Percent Change |
1 to 10 of 170Source ClinicalTrials.gov
See all 170 results by groupParticipant flow51
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind Treatment Period (12 Weeks) | STARTED | Placebo IV Q4W (DBTP) | 17 | |
| Double-Blind Treatment Period (12 Weeks) | STARTED | Evinacumab 15 mg/kg (DBTP) | 35 | |
| Double-Blind Treatment Period (12 Weeks) | STARTED | Evinacumab 15 mg/kg (SBTP) | 0 | |
| Double-Blind Treatment Period (12 Weeks) | Treated | Placebo IV Q4W (DBTP) | 16 | |
| Double-Blind Treatment Period (12 Weeks) | Treated | Evinacumab 15 mg/kg (DBTP) | 35 | |
| Double-Blind Treatment Period (12 Weeks) | Treated | Evinacumab 15 mg/kg (SBTP) | 0 | |
| Double-Blind Treatment Period (12 Weeks) | Actual Cohort 1 | Placebo IV Q4W (DBTP) | 5 | |
| Double-Blind Treatment Period (12 Weeks) | Actual Cohort 1 | Evinacumab 15 mg/kg (DBTP) | 12 | |
| Double-Blind Treatment Period (12 Weeks) | Actual Cohort 1 | Evinacumab 15 mg/kg (SBTP) | 0 | |
| Double-Blind Treatment Period (12 Weeks) | Actual Cohort 2 | Placebo IV Q4W (DBTP) | 6 |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 participant flowAdverse events332
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 | Placebo IV Q4W (DBTP) | 1 | 16 | 1 |
| other | Nasopharyngitis | Infections and infestations | Evinacumab 15 mg/kg (DBTP) | 2 | 35 | 2 |
| other | Nasopharyngitis | Infections and infestations | Evinacumab 15 mg/kg (SBTP) | 1 | 15 | 1 |
| other | Nasopharyngitis | Infections and infestations | SBTP DB/SB Evinacumab IV 15mg/kg Q4W | 3 | 32 | 3 |
| other | Upper respiratory tract infection | Infections and infestations | Placebo IV Q4W (DBTP) | 1 | 16 | 1 |
| other | Upper respiratory tract infection | Infections and infestations | Evinacumab 15 mg/kg (DBTP) | 0 | 35 | 0 |
| other | Upper respiratory tract infection | Infections and infestations | Evinacumab 15 mg/kg (SBTP) | 1 | 15 | 1 |
| other | Upper respiratory tract infection | Infections and infestations | SBTP DB/SB Evinacumab IV 15mg/kg Q4W | 1 | 32 | 1 |
| other | Urinary tract infection | Infections and infestations | Placebo IV Q4W (DBTP) | 1 | 16 | 1 |
| other | Urinary tract infection | Infections and infestations | Evinacumab 15 mg/kg (DBTP) | 0 | 35 | 0 |
1 to 10 of 332Source ClinicalTrials.gov
See all 332 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo IV Q4W (DBTP) | 0 | 16 |
| Total, all-cause mortality | Evinacumab 15 mg/kg (DBTP) | 0 | 35 |
| Total, all-cause mortality | Evinacumab 15 mg/kg (SBTP) | 0 | 15 |
| Total, all-cause mortality | SBTP DB/SB Evinacumab IV 15mg/kg Q4W | 0 | 32 |
| Total, other adverse events | Placebo IV Q4W (DBTP) | 11 | 16 |
| Total, other adverse events | Evinacumab 15 mg/kg (DBTP) | 20 | 35 |
| Total, other adverse events | Evinacumab 15 mg/kg (SBTP) | 13 | 15 |
| Total, other adverse events | SBTP DB/SB Evinacumab IV 15mg/kg Q4W | 22 | 32 |
| Total, serious adverse events | Placebo IV Q4W (DBTP) | 3 | 16 |
| Total, serious adverse events | Evinacumab 15 mg/kg (DBTP) | 4 | 35 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36879129 | DERIVED |
Source PubMed
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.
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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.
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