Study of ARO-ANG3 in Adults With Mixed Dyslipidemia (ARCHES-2)

December 1, 2025 updated by: Arrowhead Pharmaceuticals

A Double-blind, Placebo-controlled Phase 2b Study to Evaluate the Efficacy and Safety of ARO-ANG3 in Adults With Mixed Dyslipidemia

The purpose of AROANG3-2001 is to evaluate the efficacy and safety of ARO-ANG3 in participants with mixed dyslipidemia. Participants will initially receive 2 subcutaneous injections of ARO-ANG3 or placebo. Participants who complete the double-blind treatment period may opt to continue in an open-label extension during which they will receive up to 8 doses of ARO-ANG3.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.
204

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 2

Contacts and Locations

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

Study Locations

  • Australia
      • Nedlands, Australia, 6009
        • Research Site 18
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Research Site 6
    • Queensland
      • Sippy Downs, Queensland, Australia, 4556
        • Research Site 21
  • Canada
      • Québec, Canada, G1G 3Z4
        • Research Site 12
      • Québec, Canada, H7T2P5
        • Research Site 9
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Research Site 25
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 7K9
        • Research Site 16
  • New Zealand
      • Birkenhead, New Zealand, 0626
        • Research Site 19
      • Christchurch, New Zealand, 8011
        • Research Site 13
      • Hamilton, New Zealand, 3200
        • Research Site 20
      • Rotorua, New Zealand, 3010
        • Research Site 14
  • United States
    • California
      • Huntington Park, California, United States, 90255
        • Research Site 5
    • Florida
      • Hialeah, Florida, United States, 33012
        • Research Site 7
      • Miami, Florida, United States, 33144
        • Research Site 17
      • Port Orange, Florida, United States, 32127
        • Research Site 8
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Research Site 24
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Research Site 10
    • Nevada
      • Las Vegas, Nevada, United States, 89121
        • Research Site 23
    • New York
      • New York, New York, United States, 10029
        • Research Site 22
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
        • Research Site 15
      • Morehead City, North Carolina, United States, 28557
        • Research Site 2
    • Ohio
      • Marion, Ohio, United States, 43302
        • Research Site 1
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • Research Site 4
    • Texas
      • Houston, Texas, United States, 77030
        • Research Site 11

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Based on medical history, evidence of triglycerides (TG) ≥ 150 mg/dL but ≤ 499 mg/dL
  • Fasting levels at Screening of LDL-C ≥ 70 mg/dL OR non-HDL-C ≥ 100 mg/dL after at least 4 weeks of stable diet and stable optimal statin therapy
  • Mean fasting TG ≥ 150 mg/dL and ≤ 499 mg/dL during Screening collected at two separate and consecutive visits and at least 7 days apart and not more than 17 days apart
  • Willing to follow diet counseling and maintain a stable diet per Investigator judgment based on local standard of care
  • Participants of childbearing potential must agree to use highly-effective contraception during the study and for at least 24 weeks from last dose of study medication
  • Women of childbearing potential must have a negative pregnancy test and cannot be breastfeeding
  • Women of childbearing potential on hormonal contraceptives must be stable on the medication for ≥ 2 menstrual cycles prior to Day 1
  • Men must not donate sperm during the study and for at least 24 weeks following the last dose of study medication
  • Able and willing to provide written informed consent and to comply with study requirements

Exclusion Criteria:

  • Current use or use within 365 days from Day 1 of any hepatocyte targeted siRNA or antisense oligonucleotide molecule
  • Active pancreatitis within 12 weeks prior to Day 1
  • Any planned bariatric surgery or similar procedures to induce weight loss from consent to end of study
  • Acute coronary syndrome event within 24 weeks of Day 1
  • Major surgery within 12 weeks of Day 1 or planned surgery during the study
  • Planned coronary intervention (e.g., stent placement or heart bypass) during the study
  • Uncontrolled hypertension
  • Human immunodeficiency virus (HIV) infection, seropositive for Hepatitis B (HBV), seropositive for Hepatitis C (HCV)
  • Uncontrolled hypothyroidism or hyperthyroidism
  • Hemorrhagic stroke within 24 weeks of Day 1
  • History of bleeding diathesis or coagulopathy
  • Current diagnosis of nephrotic syndrome
  • Systemic use of corticosteroids or anabolic steroids within 4 weeks prior to Day 1 or planned use during the study
  • Malignancy within the last 2 years prior to date of consent requiring systemic treatment (some exceptions apply)

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 at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
Drug: ARO-ANG3
ARO-ANG3 Injection
Drug: Placebo
Sterile Normal Saline (0.9% NaCl)
Experimental: ARO-ANG3 50 mg
Two doses of ARO-ANG3 by subcutaneous (sc) injection at Day 1 and Week 12 during double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
Drug: ARO-ANG3
ARO-ANG3 Injection
Experimental: ARO-ANG3 100 mg
Two doses of ARO-ANG3 bysc injection at Day 1 and Week 12 during double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
Drug: ARO-ANG3
ARO-ANG3 Injection
Experimental: ARO-ANG3 200 mg
Two doses of ARO-ANG3 by sc injection at Day 1 and Week 12 during double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
Drug: ARO-ANG3
ARO-ANG3 Injection

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 From Baseline in Fasting TG at Week 24
Time Frame: Baseline, Week 24
Baseline, Week 24

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
Measure Description
Time Frame
Percent Change From Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 24
Time Frame: Baseline, Week 24
Baseline, Week 24
Percent Change From Baseline in Fasting Total Apolipoprotein B (ApoB) at Week 24
Time Frame: Baseline, Week 24
Baseline, Week 24
Percent Change From Baseline in Fasting Low-density Lipoprotein-Cholesterol (LDL-C) Using Ultracentrifugation at Week 24
Time Frame: Baseline, Week 24
Baseline, Week 24
Percent Change From Baseline in Angiopoietin-like Protein 3 (ANGPTL3) at Week 24
Time Frame: Baseline, Week 24
Baseline, Week 24
Percent Change From Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) at Week 24
Time Frame: Baseline, Week 24
Baseline, Week 24
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and/or Serious TEAEs up to Week 24
Time Frame: From first dose of IP up to Week 24
TEAEs are adverse events (AEs) that occur following IP administration or a pre-existing condition exacerbated following IP administration. An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is an AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction.
From first dose of IP up to Week 24
Percent Change From Baseline in Fasting TG Over Time
Time Frame: Baseline, up to Week 36 (double-blind treatment period)
Baseline, up to Week 36 (double-blind treatment period)
Percent Change From Baseline in Fasting Non-HDL-C Over Time
Time Frame: Baseline, up to Week 36 (double-blind treatment period)
Baseline, up to Week 36 (double-blind treatment period)
Percent Change From Baseline in Fasting Total ApoB Over Time
Time Frame: Baseline, up to Week 36 (double-blind treatment period)
Baseline, up to Week 36 (double-blind treatment period)
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time
Time Frame: Baseline, up to Week 36 (double-blind treatment period)
Baseline, up to Week 36 (double-blind treatment period)
Percent Change From Baseline in ANGPTL3 Over Time
Time Frame: Baseline, up to Week 36 (double-blind treatment period)
Baseline, up to Week 36 (double-blind treatment period)
Percent Change From Baseline in Fasting HDL-C Over Time
Time Frame: Baseline, up to Week 36 (double-blind treatment period)
Baseline, up to Week 36 (double-blind treatment period)
Plasma Pharmacokinetic (PK) Concentration for ARO-ANG3 Over Time in the Double-Blind Treatment Period
Time Frame: Baseline, Day 1: pre-dose, 15 minutes, 1, 3, 6 hours post-dose; Day 2: 24 hours post-dose; Week 12: pre-dose, 15 minutes, 1, 3, 6, 24 hours post-dose (double-blind treatment period)
Baseline, Day 1: pre-dose, 15 minutes, 1, 3, 6 hours post-dose; Day 2: 24 hours post-dose; Week 12: pre-dose, 15 minutes, 1, 3, 6, 24 hours post-dose (double-blind treatment period)
Number of Participants With TEAEs and/or SAEs Over Time in the Double-Blind Treatment Period
Time Frame: up to Week 36 (double-blind treatment period)
Adverse event (AE)=any untoward medical occurrence that does not necessarily have to have a causal relationship with this treatment. TEAEs=AEs with onset after administration of the study drug, or when a pre-existing medical condition increases in severity or frequency after study drug administration. Serious adverse event (SAE)= an AE that results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a medically important event or reaction.
up to Week 36 (double-blind treatment period)
Number of Participants With AEs and/or SAEs Over Time in the Open-Label Extension (OLE) Period
Time Frame: From first dose of study drug in the OLE up to Month 24 (open-label extension)
Adverse event (AE)=any untoward medical occurrence that does not necessarily have to have a causal relationship with this treatment. TEAEs=AEs with onset after administration of the study drug, or when a pre-existing medical condition increases in severity or frequency after study drug administration. Serious adverse event (SAE)= an AE that results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a medically important event or reaction.
From first dose of study drug in the OLE up to Month 24 (open-label extension)
Percent Change From Baseline in Fasting TG Over Time in the Open Label Extension (OLE) Period
Time Frame: Baseline, OLE Baseline, Months 1-24 (open-label extension)
Baseline, OLE Baseline, Months 1-24 (open-label extension)
Percent Change From Baseline in Fasting Non-HDL-C Over Time in the Open Label Extension (OLE) Period
Time Frame: Baseline, OLE Baseline, Months 1-24 (open-label extension)
Baseline, OLE Baseline, Months 1-24 (open-label extension)
Percent Change From Baseline in Fasting Total ApoB Over Time in the Open Label Extension (OLE) Period
Time Frame: Baseline, OLE Baseline, Months 1-24 (open-label extension)
Baseline, OLE Baseline, Months 1-24 (open-label extension)
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time in the Open Label Extension (OLE) Period
Time Frame: Baseline, OLE Baseline, Months 1-24 (open-label extension)
Baseline, OLE Baseline, Months 1-24 (open-label extension)
Percent Change From Baseline in ANGPTL3 Over Time in the Open Label Extension (OLE) Period
Time Frame: Baseline, OLE Baseline, Months 1-24 (open-label extension)
Baseline, OLE Baseline, Months 1-24 (open-label extension)
Percent Change From Baseline in Fasting HDL-C Over Time in the Open Label Extension (OLE) Period
Time Frame: Baseline, OLE Baseline, Months 1-24 (open-label extension)
Baseline, OLE Baseline, Months 1-24 (open-label extension)

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
June 28, 2021

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.
August 30, 2022

Study Completion (Actual)

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 25, 2024

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).
April 2, 2021

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.
April 2, 2021

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 6, 2021

Study Record Updates

Last Update Posted (Estimated)

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.
December 3, 2025

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.
December 1, 2025

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.
December 1, 2025

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.
  • AROANG3-2001

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.

Clinical Trials on Mixed Dyslipidemia

Clinical Trials on ARO-ANG3

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings