Study of Plozasiran (ARO-APOC3) in Adults With Severe Hypertriglyceridemia (SHASTA-3)

July 14, 2026 updated by: Arrowhead Pharmaceuticals

Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults With Severe Hypertriglyceridemia

This Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with severe hypertriglyceridemia (SHTG). 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. After month 12, eligible participants will be offered an opportunity to continue in an optional open-label extension under a separate protocol.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
446

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1417
        • Research Center 6
      • Buenos Aires, Argentina, C1425AGC
        • Research Center 2
      • Buenos Aires, Argentina, C1430
        • Research Center 1
      • Córdoba, Argentina, X5000AAW
        • Research Center 5
      • Córdoba, Argentina, X5006CBI
        • Research Center 3
    • Buenos Aires
      • Ramos Mejía, Buenos Aires, Argentina, B1704ETD
        • Research Center 8
      • San Isidro, Buenos Aires, Argentina, 1642
        • Research Center 10
      • Temperley, Buenos Aires, Argentina, B1834GUK
        • Research Center 7
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentina, 5000
        • Research Center 4
      • Córdoba, Córdoba Province, Argentina, 5008
        • Research Center 9
  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Research Center 1
      • Concord, New South Wales, Australia, 2139
        • Research Center 4
      • Merewether, New South Wales, Australia, 2291
        • Research Center 5
    • Victoria
      • Box Hill, Victoria, Australia, 3138
        • Research Center 2
      • Clayton, Victoria, Australia, 3168
        • Research Center 7
      • Heidelberg, Victoria, Australia, 3084
        • Research Center 3
    • Western Australia
      • Crawley, Western Australia, Australia, 6009
        • Research Center 6
  • Belgium
      • Gozée, Belgium, 6534
        • Research Center 4
      • Hasselt, Belgium, 3500
        • Research Center 6
      • Mechelen, Belgium, 2800
        • Research Center 3
      • Namur, Belgium, 5101
        • Research Center 2
      • Roeselare, Belgium, 8800
        • Research Center 5
      • Wetteren, Belgium, 9230
        • Research Center 1
  • Brazil
    • Espírito Santo
      • Vitória, Espírito Santo, Brazil, 29055-450
        • Research Center 10
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 40050-410
        • Research Center 12
      • Salvador, Estado de Bahia, Brazil, 40323-010
        • Research Center 13
      • Salvador, Estado de Bahia, Brazil, 41810-010
        • Research Center 14
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30220-140
        • Research Center 5
    • Paraná
      • Campina Grande do Sul, Paraná, Brazil, 83430-000
        • Research Center 8
      • Curitiba, Paraná, Brazil, 80730-150
        • Research Center 2
    • Pará
      • Belém, Pará, Brazil, 66073-000
        • Research Center 4
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Research Center 6
      • Porto Alegre, Rio Grande do Sul, Brazil, 90430-001
        • Research Center 9
    • São Paulo
      • Campinas, São Paulo, Brazil, 13083-190
        • Research Center 1
      • São Paulo, São Paulo, Brazil, 04266-010
        • Research Center 7
      • São Paulo, São Paulo, Brazil, 05403-000
        • Research Center 11
      • Votuporanga, São Paulo, Brazil, 15501-405
        • Research Center 3
  • Bulgaria
      • Blagoevgrad, Bulgaria, 2700
        • Research Center 12
      • Burgas, Bulgaria, 8000
        • Research Center 8
      • Kardzhali, Bulgaria, 6600
        • Research Center 10
      • Pleven, Bulgaria, 5800
        • Research Center 1
      • Pleven, Bulgaria, 5800
        • Research Center 3
      • Plovdiv, Bulgaria, 4001
        • Research Center 4
      • Plovdiv, Bulgaria, 4002
        • Research Center 2
      • Plovdiv, Bulgaria, 4004
        • Research Center 9
      • Rousse, Bulgaria, 7000
        • Research Center 11
      • Sofia, Bulgaria, 1336
        • Research Center 13
      • Sofia, Bulgaria, 1404
        • Research Center 6
      • Sofia, Bulgaria, 1431
        • Research Center 5
      • Sofia, Bulgaria, 1680
        • Research Center 14
      • Sofia, Bulgaria, 1527
        • Research Center 15
      • Sofia, Bulgaria, 1527
        • Research Center 7
  • Canada
      • Halifax, Canada, B3H 1V7
        • Research Center 7
    • British Columbia
      • Victoria, British Columbia, Canada, V8T 5G4
        • Research Center 3
    • Ontario
      • Brampton, Ontario, Canada, L6S 0C6
        • Research Center 1
      • London, Ontario, Canada, N6A 5A5
        • Research Center 8
      • Sarnia, Ontario, Canada, N7T 4X3
        • Research Center 2
      • Waterloo, Ontario, Canada, N2TOC1
        • Research Center 5
    • Quebec
      • Montreal, Quebec, Canada, H2W 1R7
        • Research Center 6
      • Québec, Quebec, Canada, G1V 4W2
        • Research Center 4
  • China
      • Hangzhou, China, 311100
        • Research Center 5
      • Liaocheng, China, 252000
        • Research Center 3
      • Nanchang, China, 330006
        • Research Center 14
    • Anhui
      • Bengbu, Anhui, China, 233004
        • Research Center 11
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100191
        • Research Center 23
      • Beijing, Beijing Municipality, China, 100730
        • Research Center 22
    • Guangdong
      • Guangzhou, Guangdong, China, 510180
        • Research Center 7
      • Guanzhou, Guangdong, China, 510080
        • Research Center 19
    • Guangxi Zhuang
      • Liuzhou, Guangxi Zhuang, China, 545006
        • Research Center 8
    • Hebei
      • Xingtai, Hebei, China, 054099
        • Research Center 13
    • Henan
      • Luoyang, Henan, China, 471003
        • Research Center 6
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Research Center 21
    • Hunan
      • Changsha, Hunan, China, 410011
        • Research Center 4
      • Changsha, Hunan, China, 410015
        • Research Center 18
    • Inner Mongolia
      • Baotou, Inner Mongolia, China, 14010
        • Research Center 16
    • Jiangsu
      • Suzhou, Jiangsu, China, 215002
        • Research Center 10
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 2000040
        • Research Center 9
      • Shanghai, Shanghai Municipality, China, 200050
        • Research Center 12
    • Shanxi
      • Yuncheng, Shanxi, China, 44000
        • Research Center 2
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Research Center 17
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300121
        • Research Center 20
    • Xicheng
      • Beijing, Xicheng, China, 10034
        • Research Center 1
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • Research Center 15
  • Croatia
      • Krapinske Toplice, Croatia, 49217
        • Research Center 2
      • Zagreb, Croatia, 10000
        • Research Center 3
      • Zagreb, Croatia, 10000
        • Research Center 4
      • Zagreb, Croatia, 10000
        • Research Center 1
  • Czechia
      • Hodonín, Czechia, 69501
        • Research Center 3
      • Hradec Králové, Czechia, 50005
        • Research Center 6
      • Ostrava, Czechia, 70200
        • Research Center 1
      • Praha 1-Nove Mesto, Czechia, 11000
        • Research Center 7
      • Praha 4-Krc, Czechia, 140 59
        • Research Center 5
      • Uherské Hradiště, Czechia, 68601
        • Research Center 2
      • Ústí nad Labem, Czechia, 40113
        • Research Center 9
    • Prague
      • Prague, Prague, Czechia, 140 21
        • Research Center 8
      • Prague, Prague, Czechia, 140 59
        • Research Center 4
  • Hungary
      • Budapest, Hungary, 1033
        • Research Center 1
      • Budapest, Hungary, 1051
        • Research Center 4
      • Budapest, Hungary, 1132
        • Research Center 2
      • Budapest, Hungary, 1152
        • Research Center 6
      • Szeged, Hungary, 6725
        • Research Center 3
      • Veszprém, Hungary, 8200
        • Research Center 5
  • Italy
      • Bologna, Italy, 40138
        • Research Center 6
      • Brescia, Italy, 25123
        • Research Center 5
      • Milan, Italy, 20162
        • Research Center 4
      • Roma, Italy, 00168
        • Research Center 1
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Research Center 3
    • Sicily
      • Palermo, Sicily, Italy, 90127
        • Research Center 2
  • Poland
      • Bydgoszcz, Poland, 85-231
        • Research Center 7
      • Elblag, Poland, 82-300
        • Research Center 11
      • Katowice, Poland, 40-752
        • Research Center 10
      • Krakow, Poland, 30-727
        • Research Center 13
      • Krakow, Poland, 31-202
        • Research Center 17
      • Krakow, Poland, 31-501
        • Research Center 8
      • Lodz, Poland, 91-363
        • Research Center 12
      • Warsaw, Poland, 00-215
        • Research Center 18
      • Warsaw, Poland, 03-291
        • Research Center 9
      • Wroclaw, Poland, 53-030
        • Research Center 16
      • Wroclaw, Poland, 53-673
        • Research Center 14
    • Swidnica
      • Żarów, Swidnica, Poland, 58-130
        • Research Center 15
  • Romania
      • Bucharest, Romania, 010192
        • Research Center 1
      • Deva, Romania, 330084
        • Research Center 8
      • Galati, Romania, 800291
        • Research Center 7
      • Târgu Mureş, Romania, 540136
        • Research Center 9
    • Brașov County
      • Brasov, Brașov County, Romania, 500091
        • Research Center 3
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400000
        • Research Center 2
    • Jud. Alba
      • Alba Iulia, Jud. Alba, Romania, 510053
        • Research Center 6
    • Jud. Prahova
      • Ploieşti, Jud. Prahova, Romania, 100342
        • Research Center 4
    • Timiș County
      • Timișoara, Timiș County, Romania, 300362
        • Research Center 5
  • Slovakia
      • Banská Bystrica, Slovakia, 97401
        • Research Center 4
      • Bardejov, Slovakia, 08501
        • Research Center 6
      • Bratislava, Slovakia, 81109
        • Research Center 5
      • Žilina, Slovakia, 10010
        • Research Center 2
    • Košice Region
      • Košice, Košice Region, Slovakia, 040 01
        • Research Center 1
      • Moldava nad Bodvou, Košice Region, Slovakia, 045 01
        • Research Center 3
  • Spain
      • Barcelona, Spain, 08023
        • Research Center 2
      • Barcelona, Spain, 08035
        • Research Center 3
      • Valencia, Spain, 46010
        • Research Center 1
      • Zaragoza, Spain, 50009
        • Research Center 4
  • United Kingdom
      • London, United Kingdom, EC1M 6BQ
        • Research Center 1
      • London, United Kingdom, N12 8BU
        • Research Center 4
    • Cornwall
      • Torpoint, Cornwall, United Kingdom, PL11 2TB
        • Research Center 3
    • Devon
      • Torquay, Devon, United Kingdom, TQ2 7AA
        • Research Center 5
    • Devpn
      • Plymouth, Devpn, United Kingdom, PL5 3JB
        • Research Center 2
  • United States
    • California
      • Garden Grove, California, United States, 92844
        • Research Center 1
      • Lake Forest, California, United States, 92630
        • Research Center 2
      • Montclair, California, United States, 91763
        • Research Center 3
      • Panorama City, California, United States, 91402
        • Research Center 4
      • Redding, California, United States, 96001
        • Research Center 5
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Research Center 6
    • Florida
      • Hialeah, Florida, United States, 33016
        • Research Center 7
      • Lake City, Florida, United States, 32055
        • Research Center 8
      • Miami Lakes, Florida, United States, 33014
        • Research Center 9
      • Mt. Dora, Florida, United States, 32757
        • Research Center 10
      • Orlando, Florida, United States, 32825
        • Research Center 11
      • Pensacola, Florida, United States, 32503
        • Research Center 12
      • Tamarac, Florida, United States, 33321
        • Research Center 13
      • Tampa, Florida, United States, 33614
        • Research Center 14
    • Georgia
      • Macon, Georgia, United States, 31210
        • Research Center 15
      • Savannah, Georgia, United States, 31401
        • Research Center 16
    • Illinois
      • Park Ridge, Illinois, United States, 60068
        • Research Center 17
    • Louisiana
      • Eunice, Louisiana, United States, 70535
        • Research Center 18
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • Research Center 19
    • Michigan
      • Flint, Michigan, United States, 48532
        • Research Center 20
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Research Center 21
    • Mississippi
      • Olive Branch, Mississippi, United States, 38654
        • Research Center 22
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Research Center 23
      • St Louis, Missouri, United States, 63136
        • Research Center 24
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Research Center 26
      • Omaha, Nebraska, United States, 68144
        • Research Center 25
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Research Center 27
    • New York
      • Long Island City, New York, United States, 11106
        • Research Center 29
      • New York, New York, United States, 10016
        • Research Center 30
      • Rochester, New York, United States, 14642
        • Research Center 31
      • The Bronx, New York, United States, 10455
        • Research Center 28
      • Vestal, New York, United States, 13850
        • Research Center 32
    • North Carolina
      • Morehead City, North Carolina, United States, 28557
        • Research Center 33
      • Winston-Salem, North Carolina, United States, 27157
        • Research Center 34
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Research Center 35
      • Columbus, Ohio, United States, 43210
        • Research Center 36
    • Oklahoma
      • Norman, Oklahoma, United States, 73072
        • Research Center 37
      • Oklahoma City, Oklahoma, United States, 73111
        • Research Center 38
    • Tennessee
      • Powell, Tennessee, United States, 37849
        • Research Center 39
    • Texas
      • El Paso, Texas, United States, 79905
        • Research Center 40
      • Houston, Texas, United States, 77029
        • Research Center 47
      • Houston, Texas, United States, 77030
        • Research Center 45
      • Houston, Texas, United States, 77030
        • Research Center 46
      • Houston, Texas, United States, 77061
        • Research Center 42
      • Houston, Texas, United States, 77074
        • Research Center 44
      • Houston, Texas, United States, 77079
        • Research Center 43
      • Houston, Texas, United States, 77095
        • Research Center 41
      • Laredo, Texas, United States, 78041
        • Research Center 48
      • Missouri City, Texas, United States, 77459
        • Research Center 49
      • Plano, Texas, United States, 75093
        • Research Center 50
      • San Antonio, Texas, United States, 78230
        • Research Center 51
    • Washington
      • Seattle, Washington, United States, 98109
        • Research Center 52

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 severe hypertriglyceridemia (SHTG) and prior documented evidence (medical history) of fasting TG levels of ≥ 500 mg/dL (≥5.65mmol/L)
  • Mean fasting TG level ≥500 mg/dL (≥5.65 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 to a previous adverse reaction associated with, attributed to, or caused by specific drug)

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
  • Known diagnosis of familial chylomicronemia syndrome (FCS) (type 1 Hyperlipoproteinemia) by documentation of confirmed homozygote or double heterozygote for loss-of-function mutations in type 1-causing genes
  • Acute pancreatitis within 4 weeks prior to screening
  • Body mass index >45kg/m^2

Note: Additional Inclusion/Exclusion criteria may apply per protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 (ARO-APOC3) by subcutaneous (sc) injection
Drug: Plozasiran Injection
ARO-APOC3 Injection
Other Names:
  • ARO-APOC3

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percent Change in Fasting Serum Triglyceride (TG) Levels from Baseline to Month 12 Compared to Placebo
Time Frame: Baseline, Month 12
Baseline, Month 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percent Change in Fasting Serum TG Levels from Baseline to Month 10 Compared to Placebo
Time Frame: Baseline, Month 10
Baseline, Month 10
Incidence Rates of New-Onset Diabetes Mellitus (NODM) Throughout the Course of Treatment
Time Frame: From first dose of study drug through Month 12
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
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
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
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
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
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
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
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
From first dose of study drug through Month 12
Percent change in non-HDL-C from baseline to Month 12 compared to placebo
Time Frame: Baseline, Month 12
Baseline, Month 12
Proportion of Participants Who Achieve Fasting TG Levels of <500 mg/dL (<5.65 mmol/L) at Month 12 Compared to Placebo
Time Frame: Baseline, Month 12
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
Time Frame: Baseline, Month 12
Baseline, Month 12
Percent change in remnant cholesterol (VLDL-C) from baseline to Month 12 compared to placebo
Time Frame: Baseline, Month 12
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
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
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
From first dose of study drug through Month 12
Change from baseline in HbA1c during the treatment period compared to placebo.
Time Frame: From first dose of study drug through Month 12
From first dose of study drug through Month 12
Change and/or percent change from baseline to Month 12 in liver fat content using MRI-PDFF, only in a subset of subjects
Time Frame: Baseline, Month 12
Baseline, Month 12
Adjudicated AP Event Rate During the Treatment Period Compared to Placebo From Day 1 to Month 12
Time Frame: Month 12
Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arrowhead Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 22, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 12, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AROAPOC3-3003
  • 2023-509300-14 (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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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