A Phase 3 interventional study of Plozasiran and Placebo in Familial Chylomicronemia, sponsored by Arrowhead Pharmaceuticals. Completed at 58 sites in 21 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-05.
Sponsored by Arrowhead Pharmaceuticals · Phase 3, Interventional, and Treatment
The purpose of AROAPOC3-3001 is to evaluate the efficacy and safety of ARO-APOC3 (plozasiran) in adult participants with familial chylomicronemia syndrome (FCS). Participants who have met all eligibility criteria will be randomized to receive 4 doses of plozasiran or matching placebo administered subcutaneously. Participants who complete the randomized period will continue in a 2-year open-label extension period where all participants will receive plozasiran.
21 studies on the registry are indexed under Hyperlipoproteinemia Type I; 3 are open to participants now.
This study's enrollment of 75 is above the median of 14 across 11 interventional studies indexed under Hyperlipoproteinemia Type I.
Browse Hyperlipoproteinemia Type I studies →Arrowhead Pharmaceuticals is the lead sponsor of 50 studies on the registry; 9 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 12 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Note: Additional Inclusion/Exclusion criteria may apply per protocol
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Randomized Period: plozasiran 25 mg Q3M for a total of 4 doses. Open-label Period (Parts A and B): plozasiran 25 mg Q3M for a total of 8 doses.
Drug: Plozasiran
Randomized Period: volume-matched placebo every 3 months (Q3M) for a total of 4 doses. Open-label Period (Parts A and B): plozasiran 25 mg Q3M for a total of 8 doses.
Drug: Plozasiran · Drug: Placebo
Randomized Period: plozasiran 25 mg Q3M for a total of 4 doses. Open-label Period: plozasiran 50 mg (Part A), then 25 mg (Part B) Q3M for a total of 8 doses.
Drug: Plozasiran
Randomized Period: volume-matched placebo every 3 months (Q3M) for a total of 4 doses. Open-label Period: plozasiran 50 mg (Part A), then 25 mg (Part B) Q3M for a total of 8 doses.
Drug: Plozasiran · Drug: Placebo
ARO-APOC3 subcutaneous (SC) injection
Also known as: ARO-APOC3
sterile normal saline (0.9% NaCl) SC injection
Percent Change From Baseline at Month 10 in Fasting Triglycerides (TG)
Time frame: Baseline, Month 10
Percent Change From Baseline in Fasting TG at Month 10 and Month 12 (Averaged)
Time frame: Baseline, Month 10, Month 12
Percent Change From Baseline in Apolipoprotein C-III (APOC3) at Month 10
Time frame: Baseline, Month 10
Percent Change From Baseline in Fasting APOC3 at Month 12
Time frame: Baseline, Month 12
Percentage of Participants With Positively Adjudicated Events of Acute Pancreatitis (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.
Time frame: From first dose of study drug through Month 12 (Randomized Period)
Percentage of Participants With Positively Adjudicated Events of Acute Pancreatitis (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.
Time frame: From first dose of study drug through Month 36 (Open-Label Period)
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Month 10
Time frame: Baseline, Month 10
Percent Change From Baseline in Non-HDL-C at Month 12
Time frame: Baseline, Month 12
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Month 10
Time frame: Baseline, Month 10
Percent Change From Baseline in HDL-C at Month 12
Time frame: Baseline, Month 12
Percent Change From Baseline in Fasting Triglycerides (TG) at Month 12
Time frame: Baseline, Month 12
Percentage of Participants Achieving Fasting TG of <500, 880, and 1000 mg/dL at Month 10
Time frame: Month 10
Percentage of Participants Achieving Fasting TG of <500, 880, and 1000 mg/dL at Month 12
Time frame: Month 12
Percentage of Participants Achieving ≥40% and ≥70% Reduction From Baseline in Fasting TG at Month 10
Time frame: Baseline, Month 10
Change From Baseline in Fasting TG Over Time
Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Percent Change From Baseline in Fasting TG Over Time
Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Number of Participants With Treatment-Emergent Adverse Events (AEs) and/or Serious Adverse Events (SAEs; Randomized Period)
AE: any untoward medical occurrence which does not necessarily have to have a causal relationship with treatment. Treatment-emergent AEs (TEAEs): AEs with onset after administration of the study drug, or when a preexisting medical condition increases in severity or frequency after study drug administration. SAE: AE that fulfills one or more of the following: results in death; is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; is an important medical event that may jeopardize the patient or may require medical intervention to prevent one of the outcomes listed above. Severity was reported as: mild, moderate, severe, life threatening, death.
Time frame: From first dose of study drug through Month 12 (Randomized Period)
Number of Participants With Treatment-Emergent AEs and/or SAEs (Open-Label Period)
AE: any untoward medical occurrence which does not necessarily have to have a causal relationship with treatment. Treatment-emergent AEs (TEAEs): AEs with onset after administration of the study drug, or when a preexisting medical condition increases in severity or frequency after study drug administration. SAE: AE that fulfills one or more of the following: results in death; is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; is an important medical event that may jeopardize the patient or may require medical intervention to prevent one of the outcomes listed above. Severity was reported as: mild, moderate, severe, life threatening, death.
Time frame: From first dose of open-label study drug through Month 36 (Open-Label Period)
| Milestone | Placebo (Pooled) | ARO-APOC3 (Plozasiran) 25 mg | ARO-APOC3 (Plozasiran) 50 mg |
|---|---|---|---|
| Started | 25 | 26 | 24 |
| Completed | 19 | 23 | 22 |
| Not completed | 6 | 3 | 2 |
| Withdrew: Due to acute pancreatitis | 3 | 0 | 0 |
| Withdrew: Due to other adverse event | 0 | 2 | 1 |
| Withdrew: Withdrawal by subject | 3 | 0 | 0 |
| Withdrew: Pregnancy | 0 | 1 | 0 |
| Withdrew: Other, not specified | 0 | 0 | 1 |
| percentage change | Placebo (Pooled) | ARO-APOC3 (Plozasiran) 25 mg | ARO-APOC3 (Plozasiran) 50 mg |
|---|---|---|---|
| Percent Change From Baseline at Month 10 in Fasting Triglycerides (TG) | -17.1 (-49.1 to 47.0) | -80.1 (-89.9 to -61.0) | -77.6 (-87.7 to -48.6) |
| percentage change | Placebo (Pooled) | ARO-APOC3 (Plozasiran) 25 mg | ARO-APOC3 (Plozasiran) 50 mg |
|---|---|---|---|
| Percent Change From Baseline in Fasting TG at Month 10 and Month 12 (Averaged) | -2.6 (-45.0 to 33.3) | -77.7 (-89.0 to -59.2) | -71.0 (-86.7 to -52.6) |
| percentage change | Placebo (Pooled) | ARO-APOC3 (Plozasiran) 25 mg | ARO-APOC3 (Plozasiran) 50 mg |
|---|---|---|---|
| Percent Change From Baseline in Apolipoprotein C-III (APOC3) at Month 10 | -1.25 (-16.59 to 26.46) | -92.95 (-97.58 to -87.86) | -96.20 (-97.71 to -89.88) |
| percentage change | Placebo (Pooled) | ARO-APOC3 (Plozasiran) 25 mg | ARO-APOC3 (Plozasiran) 50 mg |
|---|---|---|---|
| Percent Change From Baseline in Fasting APOC3 at Month 12 | 7.69 (-33.65 to 31.28) | -89.30 (-93.84 to -80.24) | -87.73 (-93.01 to -78.70) |
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.
| percentage of participants | Placebo (Pooled) | ARO-APOC3 (Plozasiran) Pooled |
|---|---|---|
| Percentage of Participants With Positively Adjudicated Events of Acute Pancreatitis (Randomized Period) | 20.0 | 4.0 |
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.
Results for this outcome have not been posted.
| percentage change | Placebo (Pooled) | ARO-APOC3 (Plozasiran) 25 mg | ARO-APOC3 (Plozasiran) 50 mg |
|---|---|---|---|
| Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Month 10 | 3.67 ± 9.454 | -38.69 ± 7.980 | -36.12 ± 8.351 |
| percentage change | Placebo (Pooled) | ARO-APOC3 (Plozasiran) 25 mg | ARO-APOC3 (Plozasiran) 50 mg |
|---|---|---|---|
| Percent Change From Baseline in Non-HDL-C at Month 12 | 6.72 ± 9.373 | -38.16 ± 7.928 | -25.48 ± 8.368 |
| percentage change | Placebo (Pooled) | ARO-APOC3 (Plozasiran) 25 mg | ARO-APOC3 (Plozasiran) 50 mg |
|---|---|---|---|
| Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Month 10 | 2.89 ± 12.281 | 65.48 ± 11.485 | 72.02 ± 12.263 |
| percentage change | Placebo (Pooled) | ARO-APOC3 (Plozasiran) 25 mg | ARO-APOC3 (Plozasiran) 50 mg |
|---|---|---|---|
| Percent Change From Baseline in HDL-C at Month 12 | 20.61 ± 17.249 | 61.90 ± 14.462 | 74.52 ± 15.775 |
| percentage change | Placebo (Pooled) | ARO-APOC3 (Plozasiran) 25 mg | ARO-APOC3 (Plozasiran) 50 mg |
|---|---|---|---|
| Percent Change From Baseline in Fasting Triglycerides (TG) at Month 12 | 0.72 ± 15.962 | -61.50 ± 14.334 | -45.38 ± 14.542 |
| percentage of participants | Placebo (Pooled) | ARO-APOC3 (Plozasiran) 25 mg | ARO-APOC3 (Plozasiran) 50 mg |
|---|---|---|---|
| <500 mg/dL (<5.6 mmol/L) | 5.3 | 50.0 | 45.5 |
| <880 mg/dL (<9.9 mmol/L) | 21.1 | 75.0 | 54.5 |
| <1000 mg/dL (<11.3 mmol/L) | 31.6 | 83.3 | 68.2 |
| percentage of participants | Placebo (Pooled) | ARO-APOC3 (Plozasiran) 25 mg | ARO-APOC3 (Plozasiran) 50 mg |
|---|---|---|---|
| <500 mg/dL (<5.6 mmol/L) | 10.5 | 45.8 | 40.9 |
| <880 mg/dL (<9.9 mmol/L) | 26.3 | 75.0 | 59.1 |
| <1000 mg/dL (<11.3 mmol/L) | 26.3 | 75.0 | 63.6 |
| percentage of participants | Placebo (Pooled) | ARO-APOC3 (Plozasiran) 25 mg | ARO-APOC3 (Plozasiran) 50 mg |
|---|---|---|---|
| ≥40% reduction from baseline fasting triglycerides | 26.3 | 95.8 | 86.4 |
| ≥70% reduction from baseline fasting triglycerides | 10.5 | 66.7 | 54.5 |
| mg/dL | Placebo (Pooled) | ARO-APOC3 (Plozasiran) 25 mg | ARO-APOC3 (Plozasiran) 50 mg |
|---|---|---|---|
| Change at Month 1 | 180.81 ± 247.835 | -1898.79 ± 205.603 | -1759.36 ± 277.758 |
| Change at Month 2 | -203.67 ± 195.740 | -1519.38 ± 203.397 | -1481.57 ± 218.704 |
| Change at Month 3 | 392.98 ± 320.073 | -1177.43 ± 212.134 | -1478.94 ± 276.681 |
| Change at Month 4 | -248.76 ± 198.553 | -1521.25 ± 291.471 | -1810.31 ± 245.695 |
| Change at Month 5 | -213.43 ± 216.851 | -1613.90 ± 176.086 | -1689.31 ± 330.096 |
| Change at Month 6 | -276.07 ± 205.490 | -1566.97 ± 201.610 | -1325.13 ± 215.809 |
| Change at Month 7 | 324.98 ± 319.233 | -1842.65 ± 210.671 | -1691.87 ± 285.252 |
| Change at Month 8 | 188.62 ± 271.286 | -1537.57 ± 190.088 | -1133.96 ± 279.984 |
| Change at Month 9 | -119.48 ± 226.547 | -1413.87 ± 232.426 | -1650.75 ± 329.600 |
| Change at Month 10 | -248.35 ± 233.539 | -1819.82 ± 227.632 | -1740.20 ± 293.567 |
| Change at Month 11 | 173.14 ± 336.713 | -1810.57 ± 296.726 | -1507.08 ± 203.964 |
| Change at Month 12 | -50.32 ± 273.674 | -1637.18 ± 274.479 | -1485.30 ± 339.662 |
| percentage change | Placebo (Pooled) | ARO-APOC3 (Plozasiran) 25 mg | ARO-APOC3 (Plozasiran) 50 mg |
|---|---|---|---|
| Percent Change at Month 1 | 13.21 ± 14.003 | -81.43 ± 2.854 | -68.21 ± 5.390 |
| Percent Change at Month 2 | -7.30 ± 10.375 | -69.33 ± 5.119 | -62.96 ± 5.940 |
| Percent Change at Month 3 | 14.66 ± 12.028 | -57.13 ± 7.424 | -60.94 ± 6.761 |
| Percent Change at Month 4 | -1.74 ± 8.861 | -68.27 ± 8.795 | -71.91 ± 5.076 |
| Percent Change at Month 5 | -9.23 ± 9.561 | -71.96 ± 5.052 | -60.41 ± 10.796 |
| Percent Change at Month 6 | -6.18 ± 12.679 | -68.08 ± 4.884 | -56.30 ± 6.317 |
| Percent Change at Month 7 | 21.45 ± 15.235 | -77.44 ± 4.082 | -65.88 ± 5.863 |
| Percent Change at Month 8 | 14.98 ± 13.745 | -68.35 ± 4.805 | -47.77 ± 11.563 |
| Percent Change at Month 9 | 4.08 ± 12.059 | -55.32 ± 8.363 | -62.72 ± 7.369 |
| Percent Change at Month 10 | -8.74 ± 11.466 | -74.45 ± 4.135 | -66.53 ± 5.951 |
| Percent Change at Month 11 | 10.40 ± 16.139 | -68.39 ± 6.776 | -63.83 ± 6.143 |
| Percent Change at Month 12 | 0.93 ± 14.858 | -67.69 ± 5.985 | -50.60 ± 14.269 |
AE: any untoward medical occurrence which does not necessarily have to have a causal relationship with treatment. Treatment-emergent AEs (TEAEs): AEs with onset after administration of the study drug, or when a preexisting medical condition increases in severity or frequency after study drug administration. SAE: AE that fulfills one or more of the following: results in death; is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; is an important medical event that may jeopardize the patient or may require medical intervention to prevent one of the outcomes listed above. Severity was reported as: mild, moderate, severe, life threatening, death.
| Participants | Placebo (Pooled) | ARO-APOC3 (Plozasiran) 25 mg | ARO-APOC3 (Plozasiran) 50 mg |
|---|---|---|---|
| All TEAEs | 20 | 23 | 20 |
| Treatment-related TEAEs | 6 | 7 | 8 |
| Serious TEAEs | 7 | 5 | 2 |
| TEAEs leading to study drug discontinuation | 0 | 2 | 1 |
| TEAEs leading to study termination | 0 | 2 | 1 |
| TEAEs of clinical interest | 1 | 4 | 2 |
| Any TEAE by maximum severity: Mild | 5 | 13 | 13 |
| Any TEAE by maximum severity: Moderate | 10 | 7 | 4 |
| Any TEAE by maximum severity: Severe | 5 | 2 | 3 |
| Any TEAE by maximum severity: Life Threatening | 0 | 1 | 0 |
| Any TEAE by maximum severity: Death | 0 | 0 | 0 |
AE: any untoward medical occurrence which does not necessarily have to have a causal relationship with treatment. Treatment-emergent AEs (TEAEs): AEs with onset after administration of the study drug, or when a preexisting medical condition increases in severity or frequency after study drug administration. SAE: AE that fulfills one or more of the following: results in death; is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; is an important medical event that may jeopardize the patient or may require medical intervention to prevent one of the outcomes listed above. Severity was reported as: mild, moderate, severe, life threatening, death.
Results for this outcome have not been posted.
Collected over Screening through Month 12 (Randomized Period). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo (Pooled) | 0/25 (0%) | 7/25 (28%) | 17/25 (68%) |
| ARO-APOC3 (Plozasiran) 25 mg | 0/26 (0%) | 5/26 (19.2%) | 21/26 (80.8%) |
| ARO-APOC3 (Plozasiran) 50 mg | 0/24 (0%) | 2/24 (8.3%) | 18/24 (75%) |
| Event | Placebo (Pooled) | ARO-APOC3 (Plozasiran) 25 mg | ARO-APOC3 (Plozasiran) 50 mg |
|---|---|---|---|
| Pancreatitis acuteGastrointestinal disorders | 3/25 | 2/26 | 0/24 |
| Pancreatitis relapsingGastrointestinal disorders | 3/25 | 0/26 | 1/24 |
| CellulitisInfections and infestations | 0/25 | 0/26 | 1/24 |
| Tooth abscessInfections and infestations | 0/25 | 0/26 | 1/24 |
| Laryngeal oedemaRespiratory, thoracic and mediastinal disorders | 0/25 | 0/26 | 1/24 |
| Coronary artery stenosisCardiac disorders | 1/25 | 0/26 | 0/24 |
| Large intestine polypGastrointestinal disorders | 1/25 | 0/26 | 0/24 |
| PancreatitisGastrointestinal disorders | 1/25 | 0/26 | 0/24 |
| Anaphylactic shockImmune system disorders | 1/25 | 0/26 | 0/24 |
| ProstatitisReproductive system and breast disorders | 1/25 | 0/26 | 0/24 |
| Event | Placebo (Pooled) | ARO-APOC3 (Plozasiran) 25 mg | ARO-APOC3 (Plozasiran) 50 mg |
|---|---|---|---|
| Abdominal painGastrointestinal disorders | 7/25 | 7/26 | 7/24 |
| COVID-19Infections and infestations | 1/25 | 5/26 | 7/24 |
| HeadacheNervous system disorders | 2/25 | 3/26 | 5/24 |
| NasopharyngitisInfections and infestations | 4/25 | 5/26 | 2/24 |
| DiarrhoeaGastrointestinal disorders | 2/25 | 1/26 | 4/24 |
| NauseaGastrointestinal disorders | 2/25 | 4/26 | 3/24 |
| Abdominal discomfortGastrointestinal disorders | 0/25 | 0/26 | 3/24 |
| Glycosylated haemoglobin increasedInvestigations | 0/25 | 3/26 | 3/24 |
| PalpitationsCardiac disorders | 0/25 | 3/26 | 0/24 |
| Upper respiratory tract infectionInfections and infestations | 2/25 | 3/26 | 2/24 |
| Age, Continuous(years) | Placebo (Pooled) | ARO-APOC3 (Plozasiran) 25 mg | ARO-APOC3 (Plozasiran) 50 mg | Total |
|---|---|---|---|---|
| Mean | 47.4 ± 13.93 | 47.9 ± 14.41 | 42.6 ± 10.85 | 46.0 ± 13.24 |
| Sex: Female, Male(Participants) | Placebo (Pooled) | ARO-APOC3 (Plozasiran) 25 mg | ARO-APOC3 (Plozasiran) 50 mg | Total |
|---|---|---|---|---|
| Female | 11 | 14 | 13 | 38 |
| Male | 14 | 12 | 11 | 37 |
| Ethnicity (NIH/OMB)(Participants) | Placebo (Pooled) | ARO-APOC3 (Plozasiran) 25 mg | ARO-APOC3 (Plozasiran) 50 mg | Total |
|---|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 | 2 |
| Not Hispanic or Latino | 24 | 26 | 22 | 72 |
| Unknown or Not Reported | 0 | 0 | 1 | 1 |
| Race/Ethnicity, Customized(Participants) | Placebo (Pooled) | ARO-APOC3 (Plozasiran) 25 mg | ARO-APOC3 (Plozasiran) 50 mg | Total |
|---|---|---|---|---|
| White | 19 | 19 | 17 | 55 |
| American Indian or Alaska Native | 0 | 0 | 1 | 1 |
| Asian | 4 | 7 | 5 | 16 |
| Other, not specified | 2 | 0 | 1 | 3 |
| Triglycerides(mg/dL) | Placebo (Pooled) | ARO-APOC3 (Plozasiran) 25 mg | ARO-APOC3 (Plozasiran) 50 mg | Total |
|---|---|---|---|---|
| Mean | 2271.91 ± 1141.426 | 2349.53 ± 1374.542 | 2491.45 ± 1523.200 | 2369.07 ± 1337.965 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2021 to primary completion in Apr 2024, 28 months.
Results were first posted in Feb 2026, 1 year 9 months after primary completion. A results delay was requested in Apr 2025.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Plozasiran