New drug shows promise for controlling dangerous fat levels in blood

NCT ID NCT06822790

Disease control Sponsor: Arrowhead Pharmaceuticals Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 4 times

Summary

This study tests the long-term safety and effectiveness of a drug called plozasiran in adults with very high triglycerides (a type of fat in the blood). About 869 people who completed earlier studies will receive injections every 3 months for 2 years. The goal is to see if the drug can safely lower triglyceride levels and reduce related health risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 869 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult males, or nonpregnant (who do not plan to become pregnant), nonlactating adult females, who are able and willing to provide written informed consent prior to the performance of any study-specific procedures * Completed all required study visits per protocol in the parent study * Female subjects of childbearing potential must agree to use a highly effective method of contraception during the study and for at least 90 days after the End of Study (EOS) or the last dose of plozasiran, whichever is later. Male subjects must agree to use a condom during the study and for at least 90 days after the EOS or last dose of plozasiran whichever is later. Subjects must not donate sperm or eggs during the study and for at least 90 days after the EOS or last dose of plozasiran, whichever is later. Female subjects of childbearing potential on hormonal contraceptives must be stable on medication for \>1 menstrual cycle prior to Day 1. * Subjects 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 to a previous adverse reaction associated with, attributed to, or caused by specific drug) * If the subject has a medical history of clinical atherosclerotic cardiovascular disease (ASCVD) or elevated 10-year ASCVD risk (eg, ≥7.5% per American Heart Association/American College of Cardiology \[AHA/ACC\] risk calculator for subjects ≥40 years of age or Framingham risk score calculator for subjects under the age of 40), the subject must be on appropriate lipid-lowering therapy as per local standard of care (ie, including moderate-to-high intensity statin, as indicated). If the subject has diabetes: 1. Subject must be on optimized antidiabetic regimen as defined by the local standards, Investigator, and institutional practices 2. Subject must have no events of diabetic ketoacidosis, diabetic decompensation/ hyperosmolar hyperglycemic nonketotic coma, diabetes complications, recurrent infections, or hospitalization related to poor glycemic control within 24 weeks of the Day 1 visit - Willing to follow diet counseling and maintain a stable low-fat diet Subjects in the USA and Canada who completed protocol AROAPOC3-2003 meeting all eligibility criteria (with the exception of inclusion criteria #9 which is not applicable to these subjects) who also meet the following additional criteria may enroll in this trial: * HbA1c ≤10% within 30 days prior to Day 1 * Completed AROAPOC3-2001 prior to entry into AROAPOC3-2003 AND either (c) or (d) below: * Baseline fasting TG level of ≥500 mg/dL and prior history of acute pancreatitis at the time of enrollment into AROAPOC3-2001 * Baseline fasting TG level of ≥1000 mg/dL at the time of enrollment into AROAPOC3-2001 * Subjects who previously met all eligibility requirements for AROAPOC3-3003, or AROAPOC3-3004 and were not permitted to proceed to randomization per Sponsor's direction in order to prevent excessive over-enrollment may also be enrolled in this trial. These subjects must meet all eligibility criteria prior to enrollment (with the exception of inclusion criteria #2 and #8 which are not applicable to these subjects) and have an HbA1c ≤10% within 30 days of Day 1. Exclusion Criteria: * Subject was permanently discontinued from receiving plozasiran in the parent study due to elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or due to HbA1c elevation that did not respond to antidiabetic regimen * Subject withdrew consent for continued study treatment in the parent study * Known hypersensitivity to the active substance or to any of the excipients of plozasiran * Known hypersensitivity to the active substance or to any of the excipients of plozasiran * Any new condition or worsening of existing condition or any other situation that in the Investigator's judgment, would make the subject unsuitable for enrollment, could interfere with the subject participating in or completing the study, would make it difficult to comply with protocol requirements, or put the subject at an additional safety risk * Unwilling to limit alcohol consumption to within moderate limits for the duration of the study. * Poorly controlled glycemia (ie, HbA1c \>10%) based upon the most recent HbA1c level reported in the parent trial prior to Day 1 * Acute pancreatitis within 4 weeks prior to Day 1 * Use of any hepatocyte-targeted siRNA that targets lipids and/or triglycerides within 365 days before Day 1 (except plozasiran or inclisiran, which are permitted). Administration of inclisiran must be separated from administration of plozasiran by at least 4 weeks throughout the treatment period * 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 PK, whichever is longer. * Use of an investigational agent (other than plozasiran) or device within 30 days or within 5 half-lives, based on plasma PK, whichever is longer, prior to Day 1 (V1) or current participation in an interventional investigational study. * Recent unstable or symptomatic cardiac arrhythmia (including any associated medication changes) within 90 days prior to Day 1. Individuals with stable well-controlled atrial arrhythmias will be allowed to participate in the study. * Uncontrolled hypertension (ie, seated systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg) at Day 1; subject may be re-evaluated when hypertension is controlled. Note: Other inclusion/exclusion criteria may apply per protocol

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Conditions

The condition(s) this trial relates to.

hypertriglyceridemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypertriglyceridemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

17 sites in 8 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Research Site 1
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Miami Lakes, Florida, 33014, United States
Research Site 10
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Manassas, Virginia, 20110, United States
Research Site 100
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Dimitrovgrad, 6400, Bulgaria
Research Site 102
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Waterloo, Ontario, N2T 0C1, Canada
Research Site 103
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Halifax, Nova Scotia, NS B3H 1V7, Canada
Research Site 104
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Beijing, Beijing Municipality, 100034, China
Research Site 105
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Yuncheng, Shanxi, 44000, China
Research Site 106
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Xingtai, Hebei, 054099, China
Research Site 108
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Changsha, Hu'nan, 410015, China
Research Site 11
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Canoga Park, California, 91303, United States
Research Site 111
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Guangzhou, Guangdong, 510180, China
Research Site 113
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Chengdu, Sichuan, 610072, China
Research Site 115
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Baotou, Inner Mongolia, 014010, China
Research Site 116
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Praha 4-Krc, 140 59, Czechia
Research Site 118
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Olomouc, CZ77900, Czechia
Research Site 119
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Prague, 11000, Czechia
Research Site 12
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Annapolis, Maryland, 21401, United States
Research Site 120
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Pessac, Gironde, 33604, France
Research Site 123
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Budapest, 1051, Hungary
Research Site 124
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Daugavpils, LV-5417, Latvia
Research Site 127
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Šiauliai, LT-76206, Lithuania
Research Site 128
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Christchurch, 08011, New Zealand
Research Site 129
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Wellington, 6021, New Zealand
Research Site 13
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Sugar Land, Texas, 77479, United States
Research Site 131
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Lodz, 94-255, Poland
Research Site 133
WITHDRAWN

Wroclaw, 51-314, Poland
Research Site 135
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Szczecin, 71- 500, Poland
Research Site 136
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Lodz, 91-363, Poland
Research Site 14
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Hialeah, Florida, 33016, United States
Research Site 140
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Wroclaw, 53-673, Poland
Research Site 141
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Katowice, 40-752, Poland
Research Site 142
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Bucharest, 010192, Romania
Research Site 143
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Ploieşti, 100342, Romania
Research Site 144
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Târgu Mureş, 540136, Romania
Research Site 145
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Timișoara, 300362, Romania
Research Site 146
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Košice, 04001, Slovakia
Research Site 147
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Bardejov, 08501, Slovakia
Research Site 148
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Rožňava, 048 01, Slovakia
Research Site 149
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Somerset West, Western Cape, 7130, South Africa
Research Site 15
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Bountiful, Utah, 84010, United States
Research Site 150
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Seville, 41013, Spain
Research Site 151
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Zaragoza, 50009, Spain
Research Site 153
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Torquay, Devon, TQ2 7AA, United Kingdom
Research Site 154
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Miami, Florida, 33144, United States
Research Site 155
WITHDRAWN

Fort Lauderdale, Florida, 33308, United States
Research Site 157
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Indianapolis, Indiana, 46290, United States
Research Site 16
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Tamarac, Florida, 33321, United States
Research Site 160
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Fort Worth, Texas, 76132, United States
Research Site 168
WITHDRAWN

San Antonio, Texas, 78230, United States
Research Site 169
RECRUITING

Wilmington, North Carolina, 28401, United States
Research Site 17
ACTIVE_NOT_RECRUITING

Park Ridge, Illinois, 60068, United States
Research Site 170
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Tomball, Texas, 77375, United States
Research Site 171
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Córdoba, X5000AAW, Argentina
Research Site 172
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Ciudad Autonoma Buenos Aires, 1425, Argentina
Research Site 173
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Ciudad Autonoma Buenos Aires, C1430CKE, Argentina
Research Site 174
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Nedlands, Western Australia, 6009, Australia
Research Site 175
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Roeselare, 8800, Belgium
Research Site 176
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Votuporanga, São Paulo, 15500-269, Brazil
Research Site 177
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São Paulo, 04266-010, Brazil
Research Site 178
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Belo Horizonte, Minas Gerais, 30150-274, Brazil
Research Site 179
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São Paulo, 05403-900, Brazil
Research Site 18
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Tampa, Florida, 33614, United States
Research Site 180
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Campinas, São Paulo, 13060-080, Brazil
Research Site 181
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Aracaju, Sergipe, 49055-530, Brazil
Research Site 182
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Sofia, 1431, Bulgaria
Research Site 184
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Sofia, 1527, Bulgaria
Research Site 185
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Plovdiv, 4001, Bulgaria
Research Site 186
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Sofia, 1431, Bulgaria
Research Site 187
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Burgas, 8000, Bulgaria
Research Site 188
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Luoyang, Henan, 471003, China
Research Site 189
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Shanghai, Shanghai Municipality, 200050, China
Research Site 19
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Québec, G1G5X1, Canada
Research Site 190
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Liaocheng, Shandong, 252000, China
Research Site 191
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Bengbu, Anhui, 233004, China
Research Site 192
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Suzhou, Jiangsu, 215002, China
Research Site 193
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Beijing, Beijing Municipality, 100091, China
Research Site 194
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Zagreb, 10000, Croatia
Research Site 195
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Ústí nad Labem, 40113, Czechia
Research Site 196
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Trutnov, 541 01, Czechia
Research Site 197
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Hradec Králové, 50005, Czechia
Research Site 198
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Teplice, 41501, Czechia
Research Site 199
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Marseille, Bouches-du-Rhône, 13005, France
Research Site 2
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Jefferson City, Missouri, 65109, United States
Research Site 20
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Victoria, British Columbia, V8T5G4, Canada
Research Site 200
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Paris, Paris, 75013, France
Research Site 201
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Magdeburg, Saxony-Anhalt, 39120, Germany
Research Site 202
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Veszprém, 8200, Hungary
Research Site 203
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Zalaegerszeg, 8900, Hungary
Research Site 204
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Budapest, 1033, Hungary
Research Site 205
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Miskolc, 3530, Hungary
Research Site 206
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Roma, 00168, Italy
Research Site 207
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Milan, 20162, Italy
Research Site 208
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Brescia, 25123, Italy
Research Site 209
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Rozzano, Milano, 20089, Italy
Research Site 21
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Bakersfield, California, 93311, United States
Research Site 210
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Palermo, 90127, Italy
Research Site 211
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Riga, LV-1002, Latvia
Research Site 212
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Daugavpils, LV-5410, Latvia
Research Site 213
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Kaunas, LT-50177, Lithuania
Research Site 214
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Vilnius, LT-08661, Lithuania
Research Site 215
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Zamość, 22-400, Poland
Research Site 216
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Warsaw, 03-291, Poland
Research Site 217
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Galati, 800291, Romania
Research Site 218
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Moldava nad Bodvou, 045 01, Slovakia
Research Site 219
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Krugersdorp, Gauteng, 1739, South Africa
Research Site 22
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Beavercreek, Ohio, 45431, United States
Research Site 220
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Cape Town, Western Cape, 7570, South Africa
Research Site 221
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Cape Town, Western Cape, 7925, South Africa
Research Site 222
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Cape Town, Western Cape, 7500, South Africa
Research Site 223
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Barcelona, 08035, Spain
Research Site 224
RECRUITING

A Coruña, La Coruña, 15006, Spain
Research Site 225
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Valencia, 46010, Spain
Research Site 226
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Madrid, 28041, Spain
Research Site 227
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London, Greater London, EC1M 6BQ, United Kingdom
Research Site 228
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New York, New York, 10029, United States
Research Site 229
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Palm Springs, California, 92262, United States
Research Site 23
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Topeka, Kansas, 66606, United States
Research Site 230
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Missouri City, Texas, 77459, United States
Research Site 231
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Philadelphia, Pennsylvania, 19104, United States
Research Site 232
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St Louis, Missouri, 63136, United States
Research Site 233
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New York, New York, 10016, United States
Research Site 234
RECRUITING

Columbus, Ohio, 43214, United States
Research Site 235
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Huntington Beach, California, 92648, United States
Research Site 236
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Lake Forest, California, 92630, United States
Research Site 237
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Lawrenceville, Georgia, 30044, United States
Research Site 238
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Fort Mill, South Carolina, 29707, United States
Research Site 239
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Córdoba, X5006CBI, Argentina
Research Site 24
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Houston, Texas, 77095, United States
Research Site 240
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Córdoba, X5008HHW, Argentina
Research Site 241
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Toronto, Ontario, M5G 2C4, Canada
Research Site 242
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Tianjin, Tianjin Municipality, 300121, China
Research Site 243
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Shanghai, Shanghai Municipality, 200040, China
Research Site 244
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Prague, 140 21, Czechia
Research Site 245
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Bologna, 40138, Italy
Research Site 246
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Kaunas, 49449, Lithuania
Research Site 247
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Gdynia, 81-338, Poland
Research Site 248
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Nitra, 950 01, Slovakia
Research Site 249
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Rosario, 2000, Argentina
Research Site 25
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Victoria, Texas, 77901, United States
Research Site 250
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Ciudad Autonoma Buenos Aires, Buenos Aires, C1128AAF, Argentina
Research Site 251
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Ramos Mejía, Buenos Aires, B1704ETD, Argentina
Research Site 252
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Heidelberg Heights, Victoria, 3081, Australia
Research Site 253
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Clayton, Victoria, 3168, Australia
Research Site 254
RECRUITING

Belém, Pará, 66073-000, Brazil
Research Site 255
ACTIVE_NOT_RECRUITING

Belo Horizonte, Minas Gerais, 30220-140, Brazil
Research Site 256
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Canoas, Rio Grande do Sul, 92425-900, Brazil
Research Site 257
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Brasília, Federal District, 70710-100, Brazil
Research Site 258
RECRUITING

Porto Alegre, Rio Grande do Sul, 90430-001, Brazil
Research Site 259
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Salvador, Estado de Bahia, 41810-010, Brazil
Research Site 26
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Horsham, Pennsylvania, 19044, United States
Research Site 260
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Sofia, 1582, Bulgaria
Research Site 261
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Wuhan, Hubei, 430060, China
Research Site 262
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Karlovac, 47000, Croatia
Research Site 263
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Slaný, 27401, Czechia
Research Site 264
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Náchod, 547 01, Czechia
Research Site 265
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Budapest, 1152, Hungary
Research Site 267
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Wroclaw, 53-030, Poland
Research Site 268
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Banská Bystrica, 97401, Slovakia
Research Site 269
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Mossel Bay, Western Cape, 6500, South Africa
Research Site 27
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El Paso, Texas, 79905, United States
Research Site 270
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Pretoria, Gauteng, 0181, South Africa
Research Site 271
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Barcelona, 08023, Spain
Research Site 272
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Houston, Texas, 77030, United States
Research Site 273
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Riverhead, New York, 12401, United States
Research Site 274
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Seattle, Washington, 98109, United States
Research Site 275
RECRUITING

Redding, California, 96001, United States
Research Site 276
ACTIVE_NOT_RECRUITING

Ciudad Autonoma Buenos Aires, C1417, Argentina
Research Site 277
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Buenos Aires, C1056ABI, Argentina
Research Site 278
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Córdoba, 5000, Argentina
Research Site 279
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Campina Grande do Sul, 83430-000, Brazil
Research Site 28
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Overland Park, Kansas, 66211, United States
Research Site 280
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Salvador, 40323-010, Brazil
Research Site 281
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Salvador, 40170310, Brazil
Research Site 282
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Sofia, 1510, Bulgaria
Research Site 283
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Sofia, 1756, Bulgaria
Research Site 284
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Deggingen, 73326, Germany
Research Site 285
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Berlin, 13353, Germany
Research Site 286
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Szeged, 6725, Hungary
Research Site 287
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Riga, LV-1038, Latvia
Research Site 288
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Cape Town, 7530, South Africa
Research Site 289
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Santiago de Compostela, 15706, Spain
Research Site 29
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Fremont, Nebraska, 68025, United States
Research Site 290
RECRUITING

Minneapolis, Minnesota, 55455, United States
Research Site 291
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Houston, Texas, 77074, United States
Research Site 292
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Houston, Texas, 77030, United States
Research Site 293
RECRUITING

Chattanooga, Tennessee, 37411, United States
Research Site 294
RECRUITING

Vandalia, Ohio, 45377, United States
Research Site 295
ACTIVE_NOT_RECRUITING

Beijing, 100730, China
Research Site 296
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Paranã, 80730-150, Brazil
Research Site 3
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Omaha, Nebraska, 68144, United States
Research Site 30
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Flint, Michigan, 48532, United States
Research Site 31
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Oklahoma City, Oklahoma, 73112, United States
Research Site 32
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Olive Branch, Mississippi, 38654, United States
Research Site 33
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Jackson, Mississippi, 39202, United States
Research Site 34
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Oxnard, California, 93030, United States
Research Site 35
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St. George, Utah, 84790, United States
Research Site 36
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Morehead City, North Carolina, 28557, United States
Research Site 37
ACTIVE_NOT_RECRUITING

Asheboro, North Carolina, 27203, United States
Research Site 38
WITHDRAWN

North Miami, Florida, 33162, United States
Research Site 39
ACTIVE_NOT_RECRUITING

Lincoln, California, 95648, United States
Research Site 4
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Québec, Quebec, G1V 4W2, Canada
Research Site 40
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Garden Grove, California, 92844, United States
Research Site 41
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Orlando, Florida, 32825, United States
Research Site 42
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Mt. Dora, Florida, 32757, United States
Research Site 43
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Elkhart, Indiana, 46514, United States
Research Site 44
ACTIVE_NOT_RECRUITING

Baltimore, Maryland, 21229, United States
Research Site 45
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Wetteren, 9230, Belgium
Research Site 46
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Namur, 5000, Belgium
Research Site 48
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Gozée, 6534, Belgium
Research Site 49
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Pleven, 5800, Bulgaria
Research Site 5
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Montreal, Quebec, H2W 1R7, Canada
Research Site 50
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Plovdiv, 4002, Bulgaria
Research Site 51
ACTIVE_NOT_RECRUITING

Sofia, 1616, Bulgaria
Research Site 52
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Kyustendil, 2500, Bulgaria
Research Site 53
RECRUITING

Sofia, 1404, Bulgaria
Research Site 55
ACTIVE_NOT_RECRUITING

Sarnia, Ontario, N7T 4X3, Canada
Research Site 56
RECRUITING

Kitchener, N2H5Z8, Canada
Research Site 59
ACTIVE_NOT_RECRUITING

Changsha, Hu'nan, 410011, China
Research Site 6
ACTIVE_NOT_RECRUITING

Chicoutimi, Quebec, G7H 7K9, Canada
Research Site 60
ACTIVE_NOT_RECRUITING

Wenzhou, Zhejiang, 325000, China
Research Site 61
ACTIVE_NOT_RECRUITING

Nanchang, Jiangxi, 330006, China
Research Site 62
RECRUITING

Guangzhou, Guangdong, 510000, China
Research Site 63
ACTIVE_NOT_RECRUITING

Liuzhou, Guangxi Zhuang, 545006, China
Research Site 65
ACTIVE_NOT_RECRUITING

Hodonín, 69501, Czechia
Research Site 66
ACTIVE_NOT_RECRUITING

Prague, 11000, Czechia
Research Site 67
ACTIVE_NOT_RECRUITING

Pécs, 7623, Hungary
Research Site 68
ACTIVE_NOT_RECRUITING

Budapest, 1132, Hungary
Research Site 69
ACTIVE_NOT_RECRUITING

Riga, LV1063, Latvia
Research Site 7
RECRUITING

London, Ontario, N6A 5K8, Canada
Research Site 70
ACTIVE_NOT_RECRUITING

Kaunas, 49387, Lithuania
Research Site 71
ACTIVE_NOT_RECRUITING

Plymouth, Devon, PL5 3JB, United Kingdom
Research Site 72
RECRUITING

Long Island City, New York, 11106, United States
Research Site 73
ACTIVE_NOT_RECRUITING

Houston, Texas, 77061, United States
Research Site 74
ACTIVE_NOT_RECRUITING

Plano, Texas, 75093, United States
Research Site 75
ACTIVE_NOT_RECRUITING

Houston, Texas, 77090, United States
Research Site 76
ACTIVE_NOT_RECRUITING

Norman, Oklahoma, 73072, United States
Research Site 77
ACTIVE_NOT_RECRUITING

Summit, New Jersey, 07901, United States
Research Site 78
ACTIVE_NOT_RECRUITING

Elblag, 82-300, Poland
Research Site 79
ACTIVE_NOT_RECRUITING

Lodz, 94-255, Poland
Research Site 8
ACTIVE_NOT_RECRUITING

Newport, Pennsylvania, 17074, United States
Research Site 80
ACTIVE_NOT_RECRUITING

Malbork, 82-200, Poland
Research Site 81
ACTIVE_NOT_RECRUITING

Katowice, 40-156, Poland
Research Site 82
ACTIVE_NOT_RECRUITING

Żarów, 58-130, Poland
Research Site 83
ACTIVE_NOT_RECRUITING

Krakow, 31-501, Poland
Research Site 84
ACTIVE_NOT_RECRUITING

Warsaw, 00-215, Poland
Research Site 85
ACTIVE_NOT_RECRUITING

Katowice, 40-752, Poland
Research Site 86
ACTIVE_NOT_RECRUITING

Box Hill, Victoria, 3128, Australia
Research Site 87
ACTIVE_NOT_RECRUITING

Hasselt, 3500, Belgium
Research Site 89
ACTIVE_NOT_RECRUITING

Namur, 5380, Belgium
Research Site 9
ACTIVE_NOT_RECRUITING

Beverly Hills, California, 90211, United States
Research Site 90
ACTIVE_NOT_RECRUITING

Mechelen, 97770, Belgium
Research Site 94
ACTIVE_NOT_RECRUITING

Rousse, 7013, Bulgaria
Research Site 97
ACTIVE_NOT_RECRUITING

Sofia, 1618, Bulgaria
Research Site 98
ACTIVE_NOT_RECRUITING

Kardzhali, 6600, Bulgaria
Research Site 99
ACTIVE_NOT_RECRUITING

Stara Zagora, 6010, Bulgaria

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