HypertriglyceridemiaPhase 3MUIR-3NCT06347133
Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia
A Phase 3 study testing Plozasiran Injection in people with Hypertriglyceridemia, run by Arrowhead Pharmaceuticals at 235 sites in 15 countries.
Trial summary
This Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with hypertriglyceridemia (HTG). After providing informed consent eligible participants will be randomized to receive 4 doses (once every 3 months) of plozasiran or placebo and be evaluated for efficacy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- Plozasiran Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,456 participants
- Where
- 235 sitesin 15 countries
- Study dates
- 21 May 2024to 8 Sep 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males, or nonpregnant (who do not plan to become pregnant) nonlactating females, who are ≥18 years of age at screening
- Established diagnosis of hypertriglyceridemia (HTG) and prior documented evidence (medical history) of mean fasting TG level ≥150 mg/dL (≥1.69 mm/L) and ≤499 mg/dL (≤5.64 mmol/L)
- Mean fasting TG level ≥150 mg/dL (≥1.69 mmol/L) and ≤499 mg/dL (≤5.64 mmol/L) collected at 2 separate and consecutive visits at least 7 days apart and no more than 17 days apart during the screening period
- Fasting low density lipoprotein-cholesterol (LDL-C) ≤ 130 mg/dL (≤3.37 mmol/L) at screening
- Screening HbA1c ≤9.0%
- Willing to follow diet counseling and maintain a stable low-fat diet
- Must be on standard of care lipid and TG-lowering medications per local guidelines (unless documented as intolerant as determined by the Investigator, including an inability to safely administer or re-administer a specific drug because of fear, preference, genetic, clinical, or metabolic considerations, or due a previous adverse reaction associated with, attributed to, or caused by specific drug) prior to collection of qualifying TG levels.
Who cannot join
- Use of any hepatocyte-targeted small interfering ribonucleic acid (siRNA) that targets lipids and/or triglycerides within 365 days before Day 1 (except inclisiran, which is permitted). Administration of investigational drug and inclisiran must be separated by at least 4 weeks.
- Use of any other hepatocyte targeted siRNA or antisense Oligonucleotide molecule within 60 days or within 5-half-lives before Day 1 based on plasma pharmacokinetics (PK), whichever is longer
- Acute pancreatitis within 4 weeks prior to screening
- Body mass index >45 kg/m^2
- Note: Additional Inclusion/Exclusion criteria may apply per protocol
Trial locations and contacts
235 sites in 15 countries.
235 sites in 15 countries
United States97 sites
Research Site 37
Annapolis, Maryland, 21401
Research Site 56
Asheboro, North Carolina, 27203
Research Site 38
Baltimore, Maryland, 21229
Research Site 60
Beavercreek, Ohio, 45431
Research Site 3
Beverly Hills, California, 90211
Research Site 1
Birmingham, Alabama, 35205
Research Site 94
Bountiful, Utah, 84010
Research Site 4
Canoga Park, California, 91303
Research Site 74
Chattanooga, Tennessee, 37411
Research Site 61
Cincinnati, Ohio, 45267
Research Site 15
Clearwater, Florida, 33756
Research Site 14
Colorado Springs, Colorado, 80909
Research Site 63
Columbus, Ohio, 43210
Research Site 62
Columbus, Ohio, 43214
Research Site 76
El Paso, Texas, 79905
Research Site 30
Elkhart, Indiana, 46514
Research Site 39
Flint, Michigan, 48532
Research Site 72
Fort Mill, South Carolina, 29707
Research Site 77
Fort Worth, Texas, 76132
Research Site 5
Garden Grove, California, 92844
Research Site 73
Greenville, South Carolina, 29607
Research Site 16
Hialeah, Florida, 33016
Research Site 67
Horsham, Pennsylvania, 19044
Research Site 86
Houston, Texas, 77029
Research Site 84
Houston, Texas, 77030
Research Site 85
Houston, Texas, 77030
Research Site 78
Houston, Texas, 77040
Research Site 80
Houston, Texas, 77061
Research Site 83
Houston, Texas, 77074
Research Site 82
Houston, Texas, 77079
Research Site 79
Houston, Texas, 77090
Research Site 81
Houston, Texas, 77095
Research Site 6
Huntington Beach, California, 92648
Research Site 31
Indianapolis, Indiana, 46290
Research Site 42
Jefferson City, Missouri, 65109
Research Site 17
Lake City, Florida, 32055
Research Site 7
Lake Forest, California, 92630
Research Site 87
Laredo, Texas, 78041
Research Site 47
Las Vegas, Nevada, 89119
Research Site 25
Lawrenceville, Georgia, 30044
Research Site 8
Lincoln, California, 95648
Research Site 9
Long Beach, California, 90822
Research Site 35
Louisville, Kentucky, 40202
Research Site 26
Macon, Georgia, 31210
Research Site 96
Manassas, Virginia, 20110
Research Site 18
Miami Lakes, Florida, 33014
Research Site 40
Minneapolis, Minnesota, 55455
Research Site 88
Missouri City, Texas, 77459
Research Site 2
Mobile, Alabama, 36604
Research Site 10
Montclair, California, 91763
Research Site 57
Morehead City, North Carolina, 28557
Research Site 19
Mt. Dora, Florida, 32757
Research Site 52
New York, New York, 10016
Research Site 51
New York, New York, 10029
Research Site 68
Newport, Pennsylvania, 17074
Research Site 69
Newport, Pennsylvania, 17074
Research Site 44
Norfolk, Nebraska, 68701
Research Site 64
Norman, Oklahoma, 73072
Research Site 20
North Miami Beach, Florida, 33162
Research Site 66
Oklahoma City, Oklahoma, 73111
Research Site 65
Oklahoma City, Oklahoma, 73112
Research Site 41
Olive Branch, Mississippi, 38654
Research Site 46
Omaha, Nebraska, 68114
Research Site 45
Omaha, Nebraska, 68144
Research Site 21
Orlando, Florida, 32825
Research Site 33
Overland Park, Kansas, 66211
Research Site 11
Oxnard, California, 93030
Research Site 29
Park Ridge, Illinois, 60068
Research Site 22
Pensacola, Florida, 32503
Research Site 70
Philadelphia, Pennsylvania, 19104
Research Site 89
Plano, Texas, 75093
Research Site 75
Powell, Tennessee, 37849
Research Site 12
Redding, California, 96001
Research Site 53
Riverhead, New York, 11901
Research Site 54
Rochester, New York, 14642
Research Site 90
San Antonio, Texas, 78230
Research Site 23
Sarasota, Florida, 34239
Research Site 27
Savannah, Georgia, 31406
Research Site 97
Seattle, Washington, 98109
Research Site 32
South Bend, Indiana, 46617
Research Site 43
St Louis, Missouri, 63136
Research Site 95
St. George, Utah, 84790
Research Site 28
Sugar Hill, Georgia, 30518
Research Site 91
Sugar Land, Texas, 77479
Research Site 48
Summit, New Jersey, 07901
Research Site 24
Tamarac, Florida, 33321
Research Site 49
The Bronx, New York, 10455
Research Site 50
The Bronx, New York, 10461
Research Site 92
Tomball, Texas, 77375
Research Site 34
Topeka, Kansas, 66606
Research Site 13
Van Nuys, California, 91402
Research Site 55
Vestal, New York, 13850
Research Site 93
Victoria, Texas, 77901
Research Site 71
Wilkes-Barre, Pennsylvania, 18711
Research Site 58
Wilmington, North Carolina, 28412
Research Site 59
Winston-Salem, North Carolina, 27157
Research Site 36
Zachary, Louisiana, 70791
Bulgaria27 sites
Research Site 111
Blagoevgrad, 2700
Research Site 112
Burgas, 8000
Research Site 113
Byala, 7100
Research Site 114
Dimitrovgrad, 6400
Research Site 115
Haskovo, 6300
Research Site 116
Kyustendil, 2500
Research Site 117
Pleven, 5800
Research Site 118
Pleven, 5800
Research Site 120
Plovdiv, 4001
Research Site 119
Plovdiv, 4002
Research Site 121
Plovdiv, 4004
Research Site 122
Rousse, 7013
Research Site 123
Sevlievo, 5400
Research Site 137
Sofia, 1202
Research Site 133
Sofia, 1336
Research Site 126
Sofia, 1431
Research Site 129
Sofia, 1431
Research Site 132
Sofia, 1431
Research Site 130
Sofia, 1510
Research Site 131
Sofia, 1527
Research Site 135
Sofia, 1527
Research Site 124
Sofia, 1616
Research Site 125
Sofia, 1618
Research Site 127
Sofia, 1680
Research Site 134
Sofia, 1680
Research Site 128
Sofia, 1750
Research Site 136
Stara Zagora, 6010
Poland19 sites
Research Site 200
Bydgoszcz, 85-065
Research Site 202
Bydgoszcz, 85-231
Research Site 192
Elblag, 82-300
Research Site 193
Gdynia, 81-338
Research Site 190
Katowice, 40-156
Research Site 197
Krakow, 30-727
Research Site 204
Krakow, 31-501
Research Site 201
Lodz, 91-363
Research Site 191
Lodz, 94-255
Research Site 194
Malbork, 82-200
Research Site 199
Szczecin, 71-500
Research Site 207
Torun, 87-100
Research Site 205
Warsaw, 00-215
Research Site 198
Warsaw, 03-291
Research Site 196
Wroclaw, 51-314
Research Site 208
Wroclaw, 53-030
Research Site 206
Wroclaw, 53-673
Research Site 195
Zamość, 22-400
Research Site 203
Żarów, 58-130
Czechia14 sites
Research Site 157
Brno, 602 00
Research Site 154
Hodonín, 69501
Research Site 159
Hradec Králové, 500 05
Research Site 160
Náchod, 547 01
Research Site 162
Olomouc, 779 00
Research Site 155
Ostrava, 702 00
Research Site 151
Prague, Prague, 140 21
Research Site 152
Prague, 101 00
Research Site 156
Praha 4-Krc, 140 59
Research Site 150
Slaný, 27401
Research Site 163
Teplice, 41501
Research Site 158
Trutnov, 541 01
Research Site 161
Uherské Hradiště, 686 01
Research Site 153
Ústí nad Labem, 40113
Hungary13 sites
Research Site 171
Békéscsaba, 5600
Research Site 175
Budapest, 1033
Research Site 183
Budapest, 1051
Research Site 179
Budapest, 1132
Research Site 184
Budapest, 1135
Research Site 180
Budapest, 1152
Research Site 182
Kaposvár, 7400
Research Site 176
Miskolc, 3530
Research Site 172
Pécs, 7623
Research Site 177
Pécs, 7635
Research Site 178
Szeged, 6725
Research Site 173
Veszprém, 8200
Research Site 174
Zalaegerszeg, 8900
Canada12 sites
Research Site 142
Brampton, Ontario, L6S 0C6
Research Site 145
Chicoutimi, Quebec, G7H 7K9
Research Site 138
Halifax, B3H 1V7
Research Site 146
Laval, Quebec, H7T 2P5
Research Site 149
Montreal, Quebec, H2W 1R7
Research Site 140
North Vancouver, British Columbia, V7M 2H4
Research Site 147
Québec, Quebec, G1V 4W2
Research Site 148
Québec, Quebec, J6X 4P7
Research Site 139
Québec, G1G 3Y8
Research Site 143
Sarnia, Ontario, N7T 4X3
Research Site 141
Victoria, British Columbia, V8T 5G4
Research Site 144
Waterloo, Ontario, N2T0C1
Slovakia10 sites
Research Site 214
Banská Bystrica, 97401
Research Site 212
Bardejov, 8501
Research Site 217
Bratislava, 81109
Research Site 216
Bratislava, 83101
Research Site 210
Košice, 040 01
Research Site 213
Moldava nad Bodvou, 045 01
Research Site 209
Nové Zámky, 94002
Research Site 211
Prešov, 8001
Research Site 215
Rožňava, 4801
Research Site 218
Žilina, 01001
South Africa10 sites
Research Site 227
Cape Town, Western Cape, 7500
Research Site 219
Cape Town, Western Cape, 7530
Research Site 223
Cape Town, Western Cape, 7550
Research Site 225
Cape Town, Western Cape, 7925
Research Site 221
Centurion, Gauteng, 0157
Research Site 224
Durban, KwaZulu-Natal, 4449
Research Site 222
Krugersdorp, Gauteng, 1739
Research Site 228
Pretoria, Gauteng, 0181
Research Site 226
Pretoria, 0184
Research Site 220
Somerset West, Western Cape, 7130
Argentina9 sites
Research Site 102
CABA, Buenos Aires, 1128
Research Site 100
CABA, Buenos Aires, 1417
Research Site 103
Ciudad Autonoma Buenos Aires, Buenos Aires, C1430CKE
Research Site 104
Córdoba, Córdoba Province, 5000
Research Site 98
Córdoba, Córdoba Province, 5006
Research Site 106
Córdoba, 5000
Research Site 101
Godoy Cruz, Mendoza Province, 5501
Research Site 105
Rosario, Santa Fe Province, 2000
Research Site 99
Rosario, Santa Fe Province, 2000
Spain6 sites
Research Site 229
A Coruña, La Coruña, 15006
Research Site 230
Barcelona, 08023
Research Site 234
Barcelona, 08035
Research Site 232
Madrid, 28041
Research Site 231
Valencia, 46010
Research Site 233
Zaragoza, 50009
Italy5 sites
Research Site 189
Bologna, 40138
Research Site 185
Brescia, 25123
Research Site 188
Milan, 20162
Research Site 187
Palermo, Sicily, 90127
Research Site 186
Rozzano, Milano, 20089
Australia4 sites
Research Site 107
Blacktown, New South Wales, 2148
Research Site 110
Clayton, Victoria, 3168
Research Site 109
Heidelberg Heights, Victoria, 3081
Research Site 108
Merewether, New South Wales, 2291
France4 sites
Research Site 166
Lyon, Rhone, 69007
Research Site 164
Marseille, Bouches Du Rhone, 13005
Research Site165
Paris, 75013
Research Site 167
Pessac, Gironde, 33604
Germany3 sites
Research Site 170
Deggingen, Baden-Wurttemberg, 73326
Research Site 168
Magdeburg, Saxony-Anhalt, 39120
Research Site 169
Wallerfing, Bavaria, 94574
United Kingdom2 sites
Research Site 235
London, EC1M 6BQ
Research Site 236
Plymouth, Devon, PL5 3JB
About this study
Official title: Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults With Hypertriglyceridemia
This Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with hypertriglyceridemia (HTG). After providing informed consent eligible participants will be randomized to receive 4 doses (once every 3 months) of plozasiran or placebo and be evaluated for efficacy and safety.
- Conditions
- Hypertriglyceridemia
- Being tested
- Plozasiran Injection, Placebo
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plozasiran InjectionDrug
Also called ARO-APOC3
ARO-APOC3 Injection
PlaceboDrug
sterile normal saline (0.9% NaCl)
| Study group | Role | What they receive |
|---|---|---|
| Plozasiran Injection | Experimental | 4 doses of plozasiran by subcutaneous (sc) injection Receives: Drug: Plozasiran Injection |
| Placebo | Placebo comparator | calculated volume to match active treatment by sc injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Fasting Serum Triglyceride (TG) Levels from Baseline to Month 12 Compared to Placebo
Measured: Baseline, Month 12
Secondary outcomes (17)
Percent Change in Fasting Serum TG Levels from Baseline to Month 10 Compared to Placebo
Measured: Baseline, Month 10
Proportion of Participants who Achieve Fasting TG Levels of <150 mg/dL (<1.69 mmol/L) at Month 12 Compared to Placebo
Measured: Month 12
Percent change in remnant cholesterol (VLDL-C) from baseline to Month 12 compared to placebo.
Measured: Baseline, Month 12
Percent change in non-HDL-C from baseline to Month 12 compared to placebo
Measured: Baseline, Month 12
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Over Time through Month 12 as Compared to Placebo
Measured: From first dose of study drug through Month 12
Incidence Rates of New-Onset Diabetes Mellitus (NODM) Throughout the Course of Treatment
Measured: From first dose of study drug through Month 12
Incidence Rates of Impaired Glucose Tolerance Throughout the Course of Treatment
Measured: From first dose of study drug through Month 12
Incidence Rates of Worsening of Existing Diabetes Throughout the Course of Treatment
Measured: From first dose of study drug through Month 12
Change from Baseline in Hemoglobin A1c (HbA1c) and Other Glycemic Control Parameters During the Treatment Period Compared to Placebo
Measured: From first dose of study drug through Month 12
Change from Baseline in Fasting Blood Glucose During the Treatment Period Compared to Placebo
Measured: From first dose of study drug through Month 12
Change from Baseline in C-peptide During the Treatment Period Compared to Placebo
Measured: From first dose of study drug through Month 12
Change from Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) During the Treatment Period Compared to Placebo
Measured: From first dose of study drug through Month 12
Change from Baseline in Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) Associated with Worsening Glycemic Control During the Treatment Period Compared to Placebo
Measured: From first dose of study drug through Month 12
Initiation of New Medication for Hyperglycemia Among Study Participants Not Known to Have Pre-existing Diabetes Mellitus During the Treatment Period Compared to Placebo
Measured: From first dose of study drug through Month 12
Adjudicated Major Adverse Cardiovascular Events (MACE) Rates During the Treatment Period Compared to Placebo
Measured: From first dose of study drug through Month 12
Incidence of Anti-drug Antibodies (ADA) to Plozasiran in Participants Receiving Plozasiran Over Time Through Month 12
Measured: From first dose of study drug through Month 12
Titers of Anti-drug Antibodies (ADA) to Plozasiran in Participants Receiving Plozasiran Over Time Through Month 12
Measured: From first dose of study drug through Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start21 May 2024
- Primary completion1 Jun 2026
- Study completion8 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
- More trials run by Arrowhead PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,456 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arrowhead Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06347133
- Sponsor's protocol ID
- AROAPOC3-3009
- Other IDs
- 2023-509302-30, 2023
- Acronym
- MUIR-3
- Status last verified
- Sep 2026
- First submitted
- 29 Mar 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults With Hypertriglyceridemia
- ClinicalTrials.gov ID
- NCT06347133
- Acronym / sponsor ID
- MUIR-3 / AROAPOC3-3009
- Conditions
- Hypertriglyceridemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,456 participants (actual)
- Lead sponsor
- Arrowhead PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 21 May 2024 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 8 Sep 2026 (actual)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with hypertriglyceridemia (HTG). After providing informed consent eligible participants will be randomized to receive 4 doses (once every 3 months) of plozasiran or placebo and be evaluated for efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plozasiran Injection | Experimental | Drug: Plozasiran Injection4 doses of plozasiran by subcutaneous (sc) injection |
| Placebo | Placebo comparator | Drug: Placebocalculated volume to match active treatment by sc injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males, or nonpregnant (who do not plan to become pregnant) nonlactating females, who are ≥18 years of age at screening
- Established diagnosis of hypertriglyceridemia (HTG) and prior documented evidence (medical history) of mean fasting TG level ≥150 mg/dL (≥1.69 mm/L) and ≤499 mg/dL (≤5.64 mmol/L)
- Mean fasting TG level ≥150 mg/dL (≥1.69 mmol/L) and ≤499 mg/dL (≤5.64 mmol/L) collected at 2 separate and consecutive visits at least 7 days apart and no more than 17 days apart during the screening period
- Fasting low density lipoprotein-cholesterol (LDL-C) ≤ 130 mg/dL (≤3.37 mmol/L) at screening
- Screening HbA1c ≤9.0%
Key exclusion criteria (5 listed)
- Use of any hepatocyte-targeted small interfering ribonucleic acid (siRNA) that targets lipids and/or triglycerides within 365 days before Day 1 (except inclisiran, which is permitted). Administration of investigational drug and inclisiran must be separated by at least 4 weeks.
- Use of any other hepatocyte targeted siRNA or antisense Oligonucleotide molecule within 60 days or within 5-half-lives before Day 1 based on plasma pharmacokinetics (PK), whichever is longer
- Acute pancreatitis within 4 weeks prior to screening
- Body mass index >45 kg/m^2
- Note: Additional Inclusion/Exclusion criteria may apply per protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plozasiran InjectionAlso: ARO-APOC3ARO-APOC3 Injection | Drug | Plozasiran Injection |
| Placebosterile normal saline (0.9% NaCl) | Drug | Placebo |
Primary outcome
Percent Change in Fasting Serum Triglyceride (TG) Levels from Baseline to Month 12 Compared to Placebo
Time frame: Baseline, Month 12
17 secondary outcomes
Percent Change in Fasting Serum TG Levels from Baseline to Month 10 Compared to Placebo
Time frame: Baseline, Month 10
Proportion of Participants who Achieve Fasting TG Levels of <150 mg/dL (<1.69 mmol/L) at Month 12 Compared to Placebo
Time frame: Month 12
Percent change in remnant cholesterol (VLDL-C) from baseline to Month 12 compared to placebo.
Time frame: Baseline, Month 12
Percent change in non-HDL-C from baseline to Month 12 compared to placebo
Time frame: Baseline, Month 12
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Over Time through Month 12 as Compared to Placebo
Time frame: From first dose of study drug through Month 12
Incidence Rates of New-Onset Diabetes Mellitus (NODM) Throughout the Course of Treatment
Time frame: From first dose of study drug through Month 12
Incidence Rates of Impaired Glucose Tolerance Throughout the Course of Treatment
Time frame: From first dose of study drug through Month 12
Incidence Rates of Worsening of Existing Diabetes Throughout the Course of Treatment
Time frame: From first dose of study drug through Month 12
Change from Baseline in Hemoglobin A1c (HbA1c) and Other Glycemic Control Parameters During the Treatment Period Compared to Placebo
Time frame: From first dose of study drug through Month 12
Change from Baseline in Fasting Blood Glucose During the Treatment Period Compared to Placebo
Time frame: From first dose of study drug through Month 12
Change from Baseline in C-peptide During the Treatment Period Compared to Placebo
Time frame: From first dose of study drug through Month 12
Change from Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) During the Treatment Period Compared to Placebo
Time frame: From first dose of study drug through Month 12
Change from Baseline in Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) Associated with Worsening Glycemic Control During the Treatment Period Compared to Placebo
Time frame: From first dose of study drug through Month 12
Initiation of New Medication for Hyperglycemia Among Study Participants Not Known to Have Pre-existing Diabetes Mellitus During the Treatment Period Compared to Placebo
Time frame: From first dose of study drug through Month 12
Adjudicated Major Adverse Cardiovascular Events (MACE) Rates During the Treatment Period Compared to Placebo
Time frame: From first dose of study drug through Month 12
Incidence of Anti-drug Antibodies (ADA) to Plozasiran in Participants Receiving Plozasiran Over Time Through Month 12
Time frame: From first dose of study drug through Month 12
Titers of Anti-drug Antibodies (ADA) to Plozasiran in Participants Receiving Plozasiran Over Time Through Month 12
Time frame: From first dose of study drug through Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
235 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Plozasiran Injection in people with Hypertriglyceridemia, run by Arrowhead Pharmaceuticals at 235 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 235 sites in United States, Bulgaria, Poland, Czechia, Hungary and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Fasting Serum Triglyceride (TG) Levels from Baseline to Month 12 Compared to Placebo (time frame: Baseline, Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.