Trial · NCT05089084
Study of ARO-APOC3 (Plozasiran) in Adults With Familial Chylomicronemia Syndrome (FCS)
NCT05089084, Phase 3, Completed, Arrowhead Pharmaceuticals; results first posted 2026-02-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of ARO-APOC3 (Plozasiran) in Adults With Familial Chylomicronemia Syndrome (FCS). Trials, record NCT05089084. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05089084
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of ARO-APOC3 (Plozasiran) in Adults With Familial Chylomicronemia Syndrome (FCS)
- NCT number
- NCT05089084
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 75 participants, actual
- Lead sponsor
- Arrowhead Pharmaceuticals
- Conditions
- Familial Chylomicronemia
- Interventions
- Plozasiran, Placebo
- First posted
- 2021-10-22
- Last updated
- 2026-06-05
- Results first posted
- 2026-02-04
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline at Month 10 in Fasting Triglycerides (TG) | Baseline, Month 10 | |
| Secondary | Percent Change From Baseline in Fasting TG at Month 10 and Month 12 (Averaged) | Baseline, Month 10, Month 12 | |
| Secondary | Percent Change From Baseline in Apolipoprotein C-III (APOC3) at Month 10 | Baseline, Month 10 | |
| Secondary | Percent Change From Baseline in Fasting APOC3 at Month 12 | Baseline, Month 12 | |
| Secondary | Percentage of Participants With Positively Adjudicated Events of Acute Pancreatitis (Randomized Period) | From first dose of study drug through Month 12 (Randomized Period) | All adverse events (AEs) and serious adverse events (SAEs) reported by the Investigator during the study that are consistent with an event of acute pancreatitis will be adjudicated by a blinded, independent committee according to the 2013 Atlanta definition meeting 2 of the following 3 criteria: 1. Abdominal pain consistent with acute pancreatitis (acute onset of a persistent, severe, epigastric pain often radiating to the back) 2. Serum lipase activity (or amylase activity) ≥3 times the upper limit of normal (×ULN) 3. Characteristic findings of acute pancreatitis on contrast-enhanced computed tomography (CECT), magnetic resonance imaging (MRI), or transabdominal ultrasonography. |
| Secondary | Percentage of Participants With Positively Adjudicated Events of Acute Pancreatitis (Open-Label Period) | From first dose of study drug through Month 36 (Open-Label Period) | All adverse events (AEs) and serious adverse events (SAEs) reported by the Investigator during the study that are consistent with an event of acute pancreatitis will be adjudicated by a blinded, independent committee according to the 2013 Atlanta definition meeting 2 of the following 3 criteria: 1. Abdominal pain consistent with acute pancreatitis (acute onset of a persistent, severe, epigastric pain often radiating to the back) 2. Serum lipase activity (or amylase activity) ≥3 times the upper limit of normal (×ULN) 3. Characteristic findings of acute pancreatitis on contrast-enhanced computed tomography (CECT), magnetic resonance imaging (MRI), or transabdominal ultrasonography. |
| Secondary | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Month 10 | Baseline, Month 10 | |
| Secondary | Percent Change From Baseline in Non-HDL-C at Month 12 | Baseline, Month 12 | |
| Secondary | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Month 10 | Baseline, Month 10 | |
| Secondary | Percent Change From Baseline in HDL-C at Month 12 | Baseline, Month 12 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
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 at Month 10 in Fasting Triglycerides (TG) | Baseline, Month 10 | Full Analysis Set: all randomized participants regardless of adherence to the treatment, analyzed according to the treatment assigned at randomization. Participants with an assessment at baseline and Month 10. | percentage change | MEDIAN |
| SECONDARY | Percent Change From Baseline in Fasting TG at Month 10 and Month 12 (Averaged) | Baseline, Month 10, Month 12 | Full Analysis Set: all randomized participants regardless of adherence to the treatment, analyzed according to the treatment assigned at randomization. Participants with an assessment at baseline and Months 10 and 12. | percentage change | MEDIAN |
| SECONDARY | Percent Change From Baseline in Apolipoprotein C-III (APOC3) at Month 10 | Baseline, Month 10 | Full Analysis Set: all randomized participants regardless of adherence to the treatment, analyzed according to the treatment assigned at randomization. Participants with an assessment at baseline and Month 10. | percentage change | MEDIAN |
| SECONDARY | Percent Change From Baseline in Fasting APOC3 at Month 12 | Baseline, Month 12 | Full Analysis Set: all randomized participants regardless of adherence to the treatment, analyzed according to the treatment assigned at randomization. Participants with an assessment at baseline and Month 12. | percentage change | MEDIAN |
| SECONDARY | Percentage of Participants With Positively Adjudicated Events of Acute Pancreatitis (Randomized Period) | From first dose of study drug through Month 12 (Randomized Period) | Full Analysis Set: all randomized participants regardless of adherence to the treatment, analyzed according to the treatment assigned at randomization. The Statistical Analysis Plan pre-specified that the ARO-APOC3 25 mg and 50 mg groups were to be pooled together to be compared with placebo for the Randomized Period. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Positively Adjudicated Events of Acute Pancreatitis (Open-Label Period) | From first dose of study drug through Month 36 (Open-Label Period) | |||
| SECONDARY | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Month 10 | Baseline, Month 10 | Full Analysis Set: all randomized participants regardless of adherence to the treatment, analyzed according to the treatment assigned at randomization. A pattern-mixture model is used as the imputation method for the missing values of Month 10 in fasting non-HDL-Cs. | percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Non-HDL-C at Month 12 | Baseline, Month 12 | Full Analysis Set: all randomized participants regardless of adherence to the treatment, analyzed according to the treatment assigned at randomization. A pattern-mixture model is used as the imputation method for the missing values of Month 12 in fasting non-HDL-Cs. | percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Month 10 | Baseline, Month 10 | Full Analysis Set: all randomized participants regardless of adherence to the treatment, analyzed according to the treatment assigned at randomization. A pattern-mixture model is used as the imputation method for the missing values of Month 10 in fasting HDL-Cs. | percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in HDL-C at Month 12 | Baseline, Month 12 | Full Analysis Set: all randomized participants regardless of adherence to the treatment, analyzed according to the treatment assigned at randomization. A pattern-mixture model is used as the imputation method for the missing values of Month 12 in fasting HDL-Cs. | percentage change | LEAST_SQUARES_MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group158
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 at Month 10 in Fasting Triglycerides (TG) | Placebo (Pooled) | -17.1 | Inter-Quartile Range -49.1 to 47.0 | percentage change | |
| Percent Change From Baseline at Month 10 in Fasting Triglycerides (TG) | ARO-APOC3 (Plozasiran) 25 mg | -80.1 | Inter-Quartile Range -89.9 to -61.0 | percentage change | |
| Percent Change From Baseline at Month 10 in Fasting Triglycerides (TG) | ARO-APOC3 (Plozasiran) 50 mg | -77.6 | Inter-Quartile Range -87.7 to -48.6 | percentage change | |
| Percent Change From Baseline in Fasting TG at Month 10 and Month 12 (Averaged) | Placebo (Pooled) | -2.6 | Inter-Quartile Range -45.0 to 33.3 | percentage change | |
| Percent Change From Baseline in Fasting TG at Month 10 and Month 12 (Averaged) | ARO-APOC3 (Plozasiran) 25 mg | -77.7 | Inter-Quartile Range -89.0 to -59.2 | percentage change | |
| Percent Change From Baseline in Fasting TG at Month 10 and Month 12 (Averaged) | ARO-APOC3 (Plozasiran) 50 mg | -71.0 | Inter-Quartile Range -86.7 to -52.6 | percentage change | |
| Percent Change From Baseline in Apolipoprotein C-III (APOC3) at Month 10 | Placebo (Pooled) | -1.25 | Inter-Quartile Range -16.59 to 26.46 | percentage change | |
| Percent Change From Baseline in Apolipoprotein C-III (APOC3) at Month 10 | ARO-APOC3 (Plozasiran) 25 mg | -92.95 | Inter-Quartile Range -97.58 to -87.86 | percentage change | |
| Percent Change From Baseline in Apolipoprotein C-III (APOC3) at Month 10 | ARO-APOC3 (Plozasiran) 50 mg | -96.20 | Inter-Quartile Range -97.71 to -89.88 | percentage change | |
| Percent Change From Baseline in Fasting APOC3 at Month 12 | Placebo (Pooled) | 7.69 | Inter-Quartile Range -33.65 to 31.28 | percentage change |
1 to 10 of 158Source ClinicalTrials.gov
See all 158 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo (Pooled) | 25 | |
| Overall Study | STARTED | ARO-APOC3 (Plozasiran) 25 mg | 26 | |
| Overall Study | STARTED | ARO-APOC3 (Plozasiran) 50 mg | 24 | |
| Overall Study | COMPLETED | Placebo (Pooled) | 19 | |
| Overall Study | COMPLETED | ARO-APOC3 (Plozasiran) 25 mg | 23 | |
| Overall Study | COMPLETED | ARO-APOC3 (Plozasiran) 50 mg | 22 | |
| Overall Study | NOT COMPLETED | Placebo (Pooled) | 6 | |
| Overall Study | NOT COMPLETED | ARO-APOC3 (Plozasiran) 25 mg | 3 | |
| Overall Study | NOT COMPLETED | ARO-APOC3 (Plozasiran) 50 mg | 2 |
Source ClinicalTrials.gov
Adverse events141
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 | Palpitations | Cardiac disorders | Placebo (Pooled) | 0 | 25 | |
| other | Palpitations | Cardiac disorders | ARO-APOC3 (Plozasiran) 25 mg | 3 | 26 | |
| other | Palpitations | Cardiac disorders | ARO-APOC3 (Plozasiran) 50 mg | 0 | 24 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo (Pooled) | 7 | 25 | |
| other | Abdominal pain | Gastrointestinal disorders | ARO-APOC3 (Plozasiran) 25 mg | 7 | 26 | |
| other | Abdominal pain | Gastrointestinal disorders | ARO-APOC3 (Plozasiran) 50 mg | 7 | 24 | |
| other | Nausea | Gastrointestinal disorders | Placebo (Pooled) | 2 | 25 | |
| other | Nausea | Gastrointestinal disorders | ARO-APOC3 (Plozasiran) 25 mg | 4 | 26 | |
| other | Nausea | Gastrointestinal disorders | ARO-APOC3 (Plozasiran) 50 mg | 3 | 24 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo (Pooled) | 2 | 25 |
1 to 10 of 141Source ClinicalTrials.gov
See all 141 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo (Pooled) | 0 | 25 |
| Total, all-cause mortality | ARO-APOC3 (Plozasiran) 25 mg | 0 | 26 |
| Total, all-cause mortality | ARO-APOC3 (Plozasiran) 50 mg | 0 | 24 |
| Total, other adverse events | Placebo (Pooled) | 17 | 25 |
| Total, other adverse events | ARO-APOC3 (Plozasiran) 25 mg | 21 | 26 |
| Total, other adverse events | ARO-APOC3 (Plozasiran) 50 mg | 18 | 24 |
| Total, serious adverse events | Placebo (Pooled) | 7 | 25 |
| Total, serious adverse events | ARO-APOC3 (Plozasiran) 25 mg | 5 | 26 |
| Total, serious adverse events | ARO-APOC3 (Plozasiran) 50 mg | 2 | 24 |
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 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/NCT05089084
GET https://conductscience.org/api/trials/v1/NCT05089084/results?page=2