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

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 Overview

• Status: Active, not recruiting
• Conditions: Hypertriglyceridemia
• Intervention / Treatment: Drug: Placebo; Drug: Plozasiran Injection

• Study Type: Interventional
• Enrollment (Actual): 1456
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Córdoba, Argentina, 5000
    • Research Site 106
  • Buenos Aires
    • CABA, Buenos Aires, Argentina, 1128
      • Research Site 102
    • CABA, Buenos Aires, Argentina, 1417
      • Research Site 100
    • Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, C1430CKE
      • Research Site 103
  • Córdoba Province
    • Córdoba, Córdoba Province, Argentina, 5000
      • Research Site 104
    • Córdoba, Córdoba Province, Argentina, 5006
      • Research Site 98
  • Mendoza Province
    • Godoy Cruz, Mendoza Province, Argentina, 5501
      • Research Site 101
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, 2000
      • Research Site 105
    • Rosario, Santa Fe Province, Argentina, 2000
      • Research Site 99
• Australia
  • New South Wales
    • Blacktown, New South Wales, Australia, 2148
      • Research Site 107
    • Merewether, New South Wales, Australia, 2291
      • Research Site 108
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Research Site 110
    • Heidelberg Heights, Victoria, Australia, 3081
      • Research Site 109
• Bulgaria
  • Blagoevgrad, Bulgaria, 2700
    • Research Site 111
  • Burgas, Bulgaria, 8000
    • Research Site 112
  • Byala, Bulgaria, 7100
    • Research Site 113
  • Dimitrovgrad, Bulgaria, 6400
    • Research Site 114
  • Haskovo, Bulgaria, 6300
    • Research Site 115
  • Kyustendil, Bulgaria, 2500
    • Research Site 116
  • Pleven, Bulgaria, 5800
    • Research Site 117
  • Pleven, Bulgaria, 5800
    • Research Site 118
  • Plovdiv, Bulgaria, 4001
    • Research Site 120
  • Plovdiv, Bulgaria, 4002
    • Research Site 119
  • Plovdiv, Bulgaria, 4004
    • Research Site 121
  • Rousse, Bulgaria, 7013
    • Research Site 122
  • Sevlievo, Bulgaria, 5400
    • Research Site 123
  • Sofia, Bulgaria, 1202
    • Research Site 137
  • Sofia, Bulgaria, 1336
    • Research Site 133
  • Sofia, Bulgaria, 1431
    • Research Site 126
  • Sofia, Bulgaria, 1431
    • Research Site 129
  • Sofia, Bulgaria, 1431
    • Research Site 132
  • Sofia, Bulgaria, 1510
    • Research Site 130
  • Sofia, Bulgaria, 1527
    • Research Site 131
  • Sofia, Bulgaria, 1527
    • Research Site 135
  • Sofia, Bulgaria, 1616
    • Research Site 124
  • Sofia, Bulgaria, 1618
    • Research Site 125
  • Sofia, Bulgaria, 1680
    • Research Site 127
  • Sofia, Bulgaria, 1680
    • Research Site 134
  • Sofia, Bulgaria, 1750
    • Research Site 128
  • Stara Zagora, Bulgaria, 6010
    • Research Site 136
• Canada
  • Halifax, Canada, B3H 1V7
    • Research Site 138
  • British Columbia
    • North Vancouver, British Columbia, Canada, V7M 2H4
      • Research Site 140
    • Victoria, British Columbia, Canada, V8T 5G4
      • Research Site 141
  • Ontario
    • Brampton, Ontario, Canada, L6S 0C6
      • Research Site 142
    • Sarnia, Ontario, Canada, N7T 4X3
      • Research Site 143
    • Waterloo, Ontario, Canada, N2T0C1
      • Research Site 144
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 7K9
      • Research Site 145
    • Laval, Quebec, Canada, H7T 2P5
      • Research Site 146
    • Montreal, Quebec, Canada, H2W 1R7
      • Research Site 149
    • Québec, Quebec, Canada, G1G 3Y8
      • Research Site 139
    • Québec, Quebec, Canada, G1V 4W2
      • Research Site 147
    • Québec, Quebec, Canada, J6X 4P7
      • Research Site 148
• Czechia
  • Brno, Czechia, 602 00
    • Research Site 157
  • Hodonín, Czechia, 69501
    • Research Site 154
  • Hradec Králové, Czechia, 500 05
    • Research Site 159
  • Náchod, Czechia, 547 01
    • Research Site 160
  • Olomouc, Czechia, 779 00
    • Research Site 162
  • Ostrava, Czechia, 702 00
    • Research Site 155
  • Prague, Czechia, 101 00
    • Research Site 152
  • Praha 4-Krc, Czechia, 140 59
    • Research Site 156
  • Slaný, Czechia, 27401
    • Research Site 150
  • Teplice, Czechia, 41501
    • Research Site 163
  • Trutnov, Czechia, 541 01
    • Research Site 158
  • Uherské Hradiště, Czechia, 686 01
    • Research Site 161
  • Ústí nad Labem, Czechia, 40113
    • Research Site 153
  • Prague
    • Prague, Prague, Czechia, 140 21
      • Research Site 151
• France
  • Paris, France, 75013
    • Research Site165
  • Bouches du Rhone
    • Marseille, Bouches du Rhone, France, 13005
      • Research Site 164
  • Gironde
    • Pessac, Gironde, France, 33604
      • Research Site 167
  • Rhone
    • Lyon, Rhone, France, 69007
      • Research Site 166
• Germany
  • Baden-Wurttemberg
    • Deggingen, Baden-Wurttemberg, Germany, 73326
      • Research Site 170
  • Bavaria
    • Wallerfing, Bavaria, Germany, 94574
      • Research Site 169
  • Saxony-Anhalt
    • Magdeburg, Saxony-Anhalt, Germany, 39120
      • Research Site 168
• Hungary
  • Budapest, Hungary, 1033
    • Research Site 175
  • Budapest, Hungary, 1051
    • Research Site 183
  • Budapest, Hungary, 1132
    • Research Site 179
  • Budapest, Hungary, 1135
    • Research Site 184
  • Budapest, Hungary, 1152
    • Research Site 180
  • Békéscsaba, Hungary, 5600
    • Research Site 171
  • Kaposvár, Hungary, 7400
    • Research Site 182
  • Miskolc, Hungary, 3530
    • Research Site 176
  • Pécs, Hungary, 7623
    • Research Site 172
  • Pécs, Hungary, 7635
    • Research Site 177
  • Szeged, Hungary, 6725
    • Research Site 178
  • Veszprém, Hungary, 8200
    • Research Site 173
  • Zalaegerszeg, Hungary, 8900
    • Research Site 174
• Italy
  • Bologna, Italy, 40138
    • Research Site 189
  • Brescia, Italy, 25123
    • Research Site 185
  • Milan, Italy, 20162
    • Research Site 188
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Research Site 186
  • Sicily
    • Palermo, Sicily, Italy, 90127
      • Research Site 187
• Poland
  • Bydgoszcz, Poland, 85-065
    • Research Site 200
  • Bydgoszcz, Poland, 85-231
    • Research Site 202
  • Elblag, Poland, 82-300
    • Research Site 192
  • Gdynia, Poland, 81-338
    • Research Site 193
  • Katowice, Poland, 40-156
    • Research Site 190
  • Krakow, Poland, 30-727
    • Research Site 197
  • Krakow, Poland, 31-501
    • Research Site 204
  • Lodz, Poland, 91-363
    • Research Site 201
  • Lodz, Poland, 94-255
    • Research Site 191
  • Malbork, Poland, 82-200
    • Research Site 194
  • Szczecin, Poland, 71-500
    • Research Site 199
  • Torun, Poland, 87-100
    • Research Site 207
  • Warsaw, Poland, 00-215
    • Research Site 205
  • Warsaw, Poland, 03-291
    • Research Site 198
  • Wroclaw, Poland, 51-314
    • Research Site 196
  • Wroclaw, Poland, 53-030
    • Research Site 208
  • Wroclaw, Poland, 53-673
    • Research Site 206
  • Zamość, Poland, 22-400
    • Research Site 195
  • Żarów, Poland, 58-130
    • Research Site 203
• Slovakia
  • Banská Bystrica, Slovakia, 97401
    • Research Site 214
  • Bardejov, Slovakia, 8501
    • Research Site 212
  • Bratislava, Slovakia, 81109
    • Research Site 217
  • Bratislava, Slovakia, 83101
    • Research Site 216
  • Košice, Slovakia, 040 01
    • Research Site 210
  • Moldava nad Bodvou, Slovakia, 045 01
    • Research Site 213
  • Nové Zámky, Slovakia, 94002
    • Research Site 209
  • Prešov, Slovakia, 8001
    • Research Site 211
  • Rožňava, Slovakia, 4801
    • Research Site 215
  • Žilina, Slovakia, 01001
    • Research Site 218
• South Africa
  • Pretoria, South Africa, 0184
    • Research Site 226
  • Gauteng
    • Centurion, Gauteng, South Africa, 0157
      • Research Site 221
    • Krugersdorp, Gauteng, South Africa, 1739
      • Research Site 222
    • Pretoria, Gauteng, South Africa, 0181
      • Research Site 228
  • KwaZulu-Natal
    • Durban, KwaZulu-Natal, South Africa, 4449
      • Research Site 224
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7500
      • Research Site 227
    • Cape Town, Western Cape, South Africa, 7530
      • Research Site 219
    • Cape Town, Western Cape, South Africa, 7550
      • Research Site 223
    • Cape Town, Western Cape, South Africa, 7925
      • Research Site 225
    • Somerset West, Western Cape, South Africa, 7130
      • Research Site 220
• Spain
  • Barcelona, Spain, 08023
    • Research Site 230
  • Madrid, Spain, 28041
    • Research Site 232
  • Valencia, Spain, 46010
    • Research Site 231
  • Zaragoza, Spain, 50009
    • Research Site 233
  • Barcelona
    • Barcelona, Barcelona, Spain, 08035
      • Research Site 234
  • La Coruña
    • A Coruña, La Coruña, Spain, 15006
      • Research Site 229
• United Kingdom
  • London, United Kingdom, EC1M 6BQ
    • Research Site 235
  • Devon
    • Plymouth, Devon, United Kingdom, PL5 3JB
      • Research Site 236
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Research Site 1
    • Mobile, Alabama, United States, 36604
      • Research Site 2
  • California
    • Beverly Hills, California, United States, 90211
      • Research Site 3
    • Canoga Park, California, United States, 91303
      • Research Site 4
    • Garden Grove, California, United States, 92844
      • Research Site 5
    • Huntington Beach, California, United States, 92648
      • Research Site 6
    • Lake Forest, California, United States, 92630
      • Research Site 7
    • Lincoln, California, United States, 95648
      • Research Site 8
    • Long Beach, California, United States, 90822
      • Research Site 9
    • Montclair, California, United States, 91763
      • Research Site 10
    • Oxnard, California, United States, 93030
      • Research Site 11
    • Redding, California, United States, 96001
      • Research Site 12
    • Van Nuys, California, United States, 91402
      • Research Site 13
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Research Site 14
  • Florida
    • Clearwater, Florida, United States, 33756
      • Research Site 15
    • Hialeah, Florida, United States, 33016
      • Research Site 16
    • Lake City, Florida, United States, 32055
      • Research Site 17
    • Miami Lakes, Florida, United States, 33014
      • Research Site 18
    • Mt. Dora, Florida, United States, 32757
      • Research Site 19
    • North Miami Beach, Florida, United States, 33162
      • Research Site 20
    • Orlando, Florida, United States, 32825
      • Research Site 21
    • Pensacola, Florida, United States, 32503
      • Research Site 22
    • Sarasota, Florida, United States, 34239
      • Research Site 23
    • Tamarac, Florida, United States, 33321
      • Research Site 24
  • Georgia
    • Lawrenceville, Georgia, United States, 30044
      • Research Site 25
    • Macon, Georgia, United States, 31210
      • Research Site 26
    • Savannah, Georgia, United States, 31406
      • Research Site 27
    • Sugar Hill, Georgia, United States, 30518
      • Research Site 28
  • Illinois
    • Park Ridge, Illinois, United States, 60068
      • Research Site 29
  • Indiana
    • Elkhart, Indiana, United States, 46514
      • Research Site 30
    • Indianapolis, Indiana, United States, 46290
      • Research Site 31
    • South Bend, Indiana, United States, 46617
      • Research Site 32
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Research Site 33
    • Topeka, Kansas, United States, 66606
      • Research Site 34
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Research Site 35
  • Louisiana
    • Zachary, Louisiana, United States, 70791
      • Research Site 36
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Research Site 37
    • Baltimore, Maryland, United States, 21229
      • Research Site 38
  • Michigan
    • Flint, Michigan, United States, 48532
      • Research Site 39
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Research Site 40
  • Mississippi
    • Olive Branch, Mississippi, United States, 38654
      • Research Site 41
  • Missouri
    • Jefferson City, Missouri, United States, 65109
      • Research Site 42
    • St Louis, Missouri, United States, 63136
      • Research Site 43
  • Nebraska
    • Norfolk, Nebraska, United States, 68701
      • Research Site 44
    • Omaha, Nebraska, United States, 68114
      • Research Site 46
    • Omaha, Nebraska, United States, 68144
      • Research Site 45
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Research Site 47
  • New Jersey
    • Summit, New Jersey, United States, 07901
      • Research Site 48
  • New York
    • New York, New York, United States, 10016
      • Research Site 52
    • New York, New York, United States, 10029
      • Research Site 51
    • Riverhead, New York, United States, 11901
      • Research Site 53
    • Rochester, New York, United States, 14642
      • Research Site 54
    • The Bronx, New York, United States, 10455
      • Research Site 49
    • The Bronx, New York, United States, 10461
      • Research Site 50
    • Vestal, New York, United States, 13850
      • Research Site 55
  • North Carolina
    • Asheboro, North Carolina, United States, 27203
      • Research Site 56
    • Morehead City, North Carolina, United States, 28557
      • Research Site 57
    • Wilmington, North Carolina, United States, 28412
      • Research Site 58
    • Winston-Salem, North Carolina, United States, 27157
      • Research Site 59
  • Ohio
    • Beavercreek, Ohio, United States, 45431
      • Research Site 60
    • Cincinnati, Ohio, United States, 45267
      • Research Site 61
    • Columbus, Ohio, United States, 43210
      • Research Site 63
    • Columbus, Ohio, United States, 43214
      • Research Site 62
  • Oklahoma
    • Norman, Oklahoma, United States, 73072
      • Research Site 64
    • Oklahoma City, Oklahoma, United States, 73111
      • Research Site 66
    • Oklahoma City, Oklahoma, United States, 73112
      • Research Site 65
  • Pennsylvania
    • Horsham, Pennsylvania, United States, 19044
      • Research Site 67
    • Newport, Pennsylvania, United States, 17074
      • Research Site 68
    • Newport, Pennsylvania, United States, 17074
      • Research Site 69
    • Philadelphia, Pennsylvania, United States, 19104
      • Research Site 70
    • Wilkes-Barre, Pennsylvania, United States, 18711
      • Research Site 71
  • South Carolina
    • Fort Mill, South Carolina, United States, 29707
      • Research Site 72
    • Greenville, South Carolina, United States, 29607
      • Research Site 73
  • Tennessee
    • Chattanooga, Tennessee, United States, 37411
      • Research Site 74
    • Powell, Tennessee, United States, 37849
      • Research Site 75
  • Texas
    • El Paso, Texas, United States, 79905
      • Research Site 76
    • Fort Worth, Texas, United States, 76132
      • Research Site 77
    • Houston, Texas, United States, 77029
      • Research Site 86
    • Houston, Texas, United States, 77030
      • Research Site 84
    • Houston, Texas, United States, 77030
      • Research Site 85
    • Houston, Texas, United States, 77040
      • Research Site 78
    • Houston, Texas, United States, 77061
      • Research Site 80
    • Houston, Texas, United States, 77074
      • Research Site 83
    • Houston, Texas, United States, 77079
      • Research Site 82
    • Houston, Texas, United States, 77090
      • Research Site 79
    • Houston, Texas, United States, 77095
      • Research Site 81
    • Laredo, Texas, United States, 78041
      • Research Site 87
    • Missouri City, Texas, United States, 77459
      • Research Site 88
    • Plano, Texas, United States, 75093
      • Research Site 89
    • San Antonio, Texas, United States, 78230
      • Research Site 90
    • Sugar Land, Texas, United States, 77479
      • Research Site 91
    • Tomball, Texas, United States, 77375
      • Research Site 92
    • Victoria, Texas, United States, 77901
      • Research Site 93
  • Utah
    • Bountiful, Utah, United States, 84010
      • Research Site 94
    • St. George, Utah, United States, 84790
      • Research Site 95
  • Virginia
    • Manassas, Virginia, United States, 20110
      • Research Site 96
  • Washington
    • Seattle, Washington, United States, 98109
      • Research Site 97

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; calculated volume to match active treatment by sc injection	Drug: Placebo; sterile normal saline (0.9% NaCl)
Experimental: Plozasiran Injection; 4 doses of plozasiran by subcutaneous (sc) injection	Drug: Plozasiran Injection; ARO-APOC3 Injection; Other Names: ARO-APOC3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent Change in Fasting Serum Triglyceride (TG) Levels from Baseline to Month 12 Compared to Placebo	Baseline, Month 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Percent Change in Fasting Serum TG Levels from Baseline to Month 10 Compared to Placebo	Baseline, Month 10
Incidence Rates of New-Onset Diabetes Mellitus (NODM) Throughout the Course of Treatment	From first dose of study drug through Month 12
Incidence Rates of Impaired Glucose Tolerance Throughout the Course of Treatment	From first dose of study drug through Month 12
Incidence Rates of Worsening of Existing Diabetes Throughout the Course of Treatment	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	From first dose of study drug through Month 12
Change from Baseline in Fasting Blood Glucose During the Treatment Period Compared to Placebo	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	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	From first dose of study drug through Month 12
Adjudicated Major Adverse Cardiovascular Events (MACE) Rates During the Treatment Period Compared to Placebo	From first dose of study drug through 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
Change from Baseline in C-peptide During the Treatment Period Compared to Placebo	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	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	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	From first dose of study drug through Month 12
Percent change in non-HDL-C from baseline to Month 12 compared to placebo	Baseline, Month 12
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

Collaborators and Investigators

• Sponsor: Arrowhead Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: March 29, 2024
• First Submitted That Met QC Criteria: March 29, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Estimated): October 8, 2025
• Last Update Submitted That Met QC Criteria: October 3, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Hypertriglyceridemia; Substandard Drugs; Pharmaceutical Preparations; plozasiran
• Other Study ID Numbers: AROAPOC3-3009; 2023-509302-30 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No