Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia
MUIR-3
Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults With Hypertriglyceridemia
2 other identifiers
interventional
1,456
15 countries
235
Brief 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 and safety.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2024
235 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2024
CompletedFirst Posted
Study publicly available on registry
April 4, 2024
CompletedStudy Start
First participant enrolled
May 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
ExpectedOctober 8, 2025
October 1, 2025
1.9 years
March 29, 2024
October 3, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Change in Fasting Serum Triglyceride (TG) Levels from Baseline to Month 12 Compared to Placebo
Baseline, Month 12
Secondary Outcomes (17)
Percent Change in Fasting Serum TG Levels from Baseline to Month 10 Compared to Placebo
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
Month 12
Percent change in remnant cholesterol (VLDL-C) from baseline to Month 12 compared to placebo.
Baseline, Month 12
Percent change in non-HDL-C from baseline to Month 12 compared to placebo
Baseline, Month 12
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Over Time through Month 12 as Compared to Placebo
From first dose of study drug through Month 12
- +12 more secondary outcomes
Study Arms (2)
Plozasiran Injection
EXPERIMENTAL4 doses of plozasiran by subcutaneous (sc) injection
Placebo
PLACEBO COMPARATORcalculated volume to match active treatment by sc injection
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (235)
Research Site 1
Birmingham, Alabama, 35205, United States
Research Site 2
Mobile, Alabama, 36604, United States
Research Site 3
Beverly Hills, California, 90211, United States
Research Site 4
Canoga Park, California, 91303, United States
Research Site 5
Garden Grove, California, 92844, United States
Research Site 6
Huntington Beach, California, 92648, United States
Research Site 7
Lake Forest, California, 92630, United States
Research Site 8
Lincoln, California, 95648, United States
Research Site 9
Long Beach, California, 90822, United States
Research Site 10
Montclair, California, 91763, United States
Research Site 11
Oxnard, California, 93030, United States
Research Site 12
Redding, California, 96001, United States
Research Site 13
Van Nuys, California, 91402, United States
Research Site 14
Colorado Springs, Colorado, 80909, United States
Research Site 15
Clearwater, Florida, 33756, United States
Research Site 16
Hialeah, Florida, 33016, United States
Research Site 17
Lake City, Florida, 32055, United States
Research Site 18
Miami Lakes, Florida, 33014, United States
Research Site 19
Mt. Dora, Florida, 32757, United States
Research Site 20
North Miami Beach, Florida, 33162, United States
Research Site 21
Orlando, Florida, 32825, United States
Research Site 22
Pensacola, Florida, 32503, United States
Research Site 23
Sarasota, Florida, 34239, United States
Research Site 24
Tamarac, Florida, 33321, United States
Research Site 25
Lawrenceville, Georgia, 30044, United States
Research Site 26
Macon, Georgia, 31210, United States
Research Site 27
Savannah, Georgia, 31406, United States
Research Site 28
Sugar Hill, Georgia, 30518, United States
Research Site 29
Park Ridge, Illinois, 60068, United States
Research Site 30
Elkhart, Indiana, 46514, United States
Research Site 31
Indianapolis, Indiana, 46290, United States
Research Site 32
South Bend, Indiana, 46617, United States
Research Site 33
Overland Park, Kansas, 66211, United States
Research Site 34
Topeka, Kansas, 66606, United States
Research Site 35
Louisville, Kentucky, 40202, United States
Research Site 36
Zachary, Louisiana, 70791, United States
Research Site 37
Annapolis, Maryland, 21401, United States
Research Site 38
Baltimore, Maryland, 21229, United States
Research Site 39
Flint, Michigan, 48532, United States
Research Site 40
Minneapolis, Minnesota, 55455, United States
Research Site 41
Olive Branch, Mississippi, 38654, United States
Research Site 42
Jefferson City, Missouri, 65109, United States
Research Site 43
St Louis, Missouri, 63136, United States
Research Site 44
Norfolk, Nebraska, 68701, United States
Research Site 46
Omaha, Nebraska, 68114, United States
Research Site 45
Omaha, Nebraska, 68144, United States
Research Site 47
Las Vegas, Nevada, 89119, United States
Research Site 48
Summit, New Jersey, 07901, United States
Research Site 52
New York, New York, 10016, United States
Research Site 51
New York, New York, 10029, United States
Research Site 53
Riverhead, New York, 11901, United States
Research Site 54
Rochester, New York, 14642, United States
Research Site 49
The Bronx, New York, 10455, United States
Research Site 50
The Bronx, New York, 10461, United States
Research Site 55
Vestal, New York, 13850, United States
Research Site 56
Asheboro, North Carolina, 27203, United States
Research Site 57
Morehead City, North Carolina, 28557, United States
Research Site 58
Wilmington, North Carolina, 28412, United States
Research Site 59
Winston-Salem, North Carolina, 27157, United States
Research Site 60
Beavercreek, Ohio, 45431, United States
Research Site 61
Cincinnati, Ohio, 45267, United States
Research Site 63
Columbus, Ohio, 43210, United States
Research Site 62
Columbus, Ohio, 43214, United States
Research Site 64
Norman, Oklahoma, 73072, United States
Research Site 66
Oklahoma City, Oklahoma, 73111, United States
Research Site 65
Oklahoma City, Oklahoma, 73112, United States
Research Site 67
Horsham, Pennsylvania, 19044, United States
Research Site 68
Newport, Pennsylvania, 17074, United States
Research Site 69
Newport, Pennsylvania, 17074, United States
Research Site 70
Philadelphia, Pennsylvania, 19104, United States
Research Site 71
Wilkes-Barre, Pennsylvania, 18711, United States
Research Site 72
Fort Mill, South Carolina, 29707, United States
Research Site 73
Greenville, South Carolina, 29607, United States
Research Site 74
Chattanooga, Tennessee, 37411, United States
Research Site 75
Powell, Tennessee, 37849, United States
Research Site 76
El Paso, Texas, 79905, United States
Research Site 77
Fort Worth, Texas, 76132, United States
Research Site 86
Houston, Texas, 77029, United States
Research Site 84
Houston, Texas, 77030, United States
Research Site 85
Houston, Texas, 77030, United States
Research Site 78
Houston, Texas, 77040, United States
Research Site 80
Houston, Texas, 77061, United States
Research Site 83
Houston, Texas, 77074, United States
Research Site 82
Houston, Texas, 77079, United States
Research Site 79
Houston, Texas, 77090, United States
Research Site 81
Houston, Texas, 77095, United States
Research Site 87
Laredo, Texas, 78041, United States
Research Site 88
Missouri City, Texas, 77459, United States
Research Site 89
Plano, Texas, 75093, United States
Research Site 90
San Antonio, Texas, 78230, United States
Research Site 91
Sugar Land, Texas, 77479, United States
Research Site 92
Tomball, Texas, 77375, United States
Research Site 93
Victoria, Texas, 77901, United States
Research Site 94
Bountiful, Utah, 84010, United States
Research Site 95
St. George, Utah, 84790, United States
Research Site 96
Manassas, Virginia, 20110, United States
Research Site 97
Seattle, Washington, 98109, United States
Research Site 102
CABA, Buenos Aires, 1128, Argentina
Research Site 100
CABA, Buenos Aires, 1417, Argentina
Research Site 103
Ciudad Autonoma Buenos Aires, Buenos Aires, C1430CKE, Argentina
Research Site 104
Córdoba, Córdoba Province, 5000, Argentina
Research Site 98
Córdoba, Córdoba Province, 5006, Argentina
Research Site 101
Godoy Cruz, Mendoza Province, 5501, Argentina
Research Site 105
Rosario, Santa Fe Province, 2000, Argentina
Research Site 99
Rosario, Santa Fe Province, 2000, Argentina
Research Site 106
Córdoba, 5000, Argentina
Research Site 107
Blacktown, New South Wales, 2148, Australia
Research Site 108
Merewether, New South Wales, 2291, Australia
Research Site 110
Clayton, Victoria, 3168, Australia
Research Site 109
Heidelberg Heights, Victoria, 3081, Australia
Research Site 111
Blagoevgrad, 2700, Bulgaria
Research Site 112
Burgas, 8000, Bulgaria
Research Site 113
Byala, 7100, Bulgaria
Research Site 114
Dimitrovgrad, 6400, Bulgaria
Research Site 115
Haskovo, 6300, Bulgaria
Research Site 116
Kyustendil, 2500, Bulgaria
Research Site 117
Pleven, 5800, Bulgaria
Research Site 118
Pleven, 5800, Bulgaria
Research Site 120
Plovdiv, 4001, Bulgaria
Research Site 119
Plovdiv, 4002, Bulgaria
Research Site 121
Plovdiv, 4004, Bulgaria
Research Site 122
Rousse, 7013, Bulgaria
Research Site 123
Sevlievo, 5400, Bulgaria
Research Site 137
Sofia, 1202, Bulgaria
Research Site 133
Sofia, 1336, Bulgaria
Research Site 126
Sofia, 1431, Bulgaria
Research Site 129
Sofia, 1431, Bulgaria
Research Site 132
Sofia, 1431, Bulgaria
Research Site 130
Sofia, 1510, Bulgaria
Research Site 131
Sofia, 1527, Bulgaria
Research Site 135
Sofia, 1527, Bulgaria
Research Site 124
Sofia, 1616, Bulgaria
Research Site 125
Sofia, 1618, Bulgaria
Research Site 127
Sofia, 1680, Bulgaria
Research Site 134
Sofia, 1680, Bulgaria
Research Site 128
Sofia, 1750, Bulgaria
Research Site 136
Stara Zagora, 6010, Bulgaria
Research Site 140
North Vancouver, British Columbia, V7M 2H4, Canada
Research Site 141
Victoria, British Columbia, V8T 5G4, Canada
Research Site 142
Brampton, Ontario, L6S 0C6, Canada
Research Site 143
Sarnia, Ontario, N7T 4X3, Canada
Research Site 144
Waterloo, Ontario, N2T0C1, Canada
Research Site 145
Chicoutimi, Quebec, G7H 7K9, Canada
Research Site 146
Laval, Quebec, H7T 2P5, Canada
Research Site 149
Montreal, Quebec, H2W 1R7, Canada
Research Site 139
Québec, Quebec, G1G 3Y8, Canada
Research Site 147
Québec, Quebec, G1V 4W2, Canada
Research Site 148
Québec, Quebec, J6X 4P7, Canada
Research Site 138
Halifax, B3H 1V7, Canada
Research Site 151
Prague, Prague, 140 21, Czechia
Research Site 157
Brno, 602 00, Czechia
Research Site 154
Hodonín, 69501, Czechia
Research Site 159
Hradec Králové, 500 05, Czechia
Research Site 160
Náchod, 547 01, Czechia
Research Site 162
Olomouc, 779 00, Czechia
Research Site 155
Ostrava, 702 00, Czechia
Research Site 152
Prague, 101 00, Czechia
Research Site 156
Praha 4-Krc, 140 59, Czechia
Research Site 150
Slaný, 27401, Czechia
Research Site 163
Teplice, 41501, Czechia
Research Site 158
Trutnov, 541 01, Czechia
Research Site 161
Uherské Hradiště, 686 01, Czechia
Research Site 153
Ústí nad Labem, 40113, Czechia
Research Site 164
Marseille, Bouches du Rhone, 13005, France
Research Site 167
Pessac, Gironde, 33604, France
Research Site 166
Lyon, Rhone, 69007, France
Research Site165
Paris, 75013, France
Research Site 170
Deggingen, Baden-Wurttemberg, 73326, Germany
Research Site 169
Wallerfing, Bavaria, 94574, Germany
Research Site 168
Magdeburg, Saxony-Anhalt, 39120, Germany
Research Site 171
Békéscsaba, 5600, Hungary
Research Site 175
Budapest, 1033, Hungary
Research Site 183
Budapest, 1051, Hungary
Research Site 179
Budapest, 1132, Hungary
Research Site 184
Budapest, 1135, Hungary
Research Site 180
Budapest, 1152, Hungary
Research Site 182
Kaposvár, 7400, Hungary
Research Site 176
Miskolc, 3530, Hungary
Research Site 172
Pécs, 7623, Hungary
Research Site 177
Pécs, 7635, Hungary
Research Site 178
Szeged, 6725, Hungary
Research Site 173
Veszprém, 8200, Hungary
Research Site 174
Zalaegerszeg, 8900, Hungary
Research Site 186
Rozzano, Milano, 20089, Italy
Research Site 187
Palermo, Sicily, 90127, Italy
Research Site 189
Bologna, 40138, Italy
Research Site 185
Brescia, 25123, Italy
Research Site 188
Milan, 20162, Italy
Research Site 200
Bydgoszcz, 85-065, Poland
Research Site 202
Bydgoszcz, 85-231, Poland
Research Site 192
Elblag, 82-300, Poland
Research Site 193
Gdynia, 81-338, Poland
Research Site 190
Katowice, 40-156, Poland
Research Site 197
Krakow, 30-727, Poland
Research Site 204
Krakow, 31-501, Poland
Research Site 201
Lodz, 91-363, Poland
Research Site 191
Lodz, 94-255, Poland
Research Site 194
Malbork, 82-200, Poland
Research Site 199
Szczecin, 71-500, Poland
Research Site 207
Torun, 87-100, Poland
Research Site 205
Warsaw, 00-215, Poland
Research Site 198
Warsaw, 03-291, Poland
Research Site 196
Wroclaw, 51-314, Poland
Research Site 208
Wroclaw, 53-030, Poland
Research Site 206
Wroclaw, 53-673, Poland
Research Site 195
Zamość, 22-400, Poland
Research Site 203
Żarów, 58-130, Poland
Research Site 214
Banská Bystrica, 97401, Slovakia
Research Site 212
Bardejov, 8501, Slovakia
Research Site 217
Bratislava, 81109, Slovakia
Research Site 216
Bratislava, 83101, Slovakia
Research Site 210
Košice, 040 01, Slovakia
Research Site 213
Moldava nad Bodvou, 045 01, Slovakia
Research Site 209
Nové Zámky, 94002, Slovakia
Research Site 211
Prešov, 8001, Slovakia
Research Site 215
Rožňava, 4801, Slovakia
Research Site 218
Žilina, 01001, Slovakia
Research Site 221
Centurion, Gauteng, 0157, South Africa
Research Site 222
Krugersdorp, Gauteng, 1739, South Africa
Research Site 228
Pretoria, Gauteng, 0181, South Africa
Research Site 224
Durban, KwaZulu-Natal, 4449, South Africa
Research Site 227
Cape Town, Western Cape, 7500, South Africa
Research Site 219
Cape Town, Western Cape, 7530, South Africa
Research Site 223
Cape Town, Western Cape, 7550, South Africa
Research Site 225
Cape Town, Western Cape, 7925, South Africa
Research Site 220
Somerset West, Western Cape, 7130, South Africa
Research Site 226
Pretoria, 0184, South Africa
Research Site 234
Barcelona, Barcelona, 08035, Spain
Research Site 229
A Coruña, La Coruña, 15006, Spain
Research Site 230
Barcelona, 08023, Spain
Research Site 232
Madrid, 28041, Spain
Research Site 231
Valencia, 46010, Spain
Research Site 233
Zaragoza, 50009, Spain
Research Site 236
Plymouth, Devon, PL5 3JB, United Kingdom
Research Site 235
London, EC1M 6BQ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2024
First Posted
April 4, 2024
Study Start
May 21, 2024
Primary Completion
May 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
October 8, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share