Mixed DyslipidemiaPhase 2ARCHES-2NCT04832971
Study of ARO-ANG3 in Adults With Mixed Dyslipidemia
A Phase 2 study testing ARO-ANG3 in people with Mixed Dyslipidemia, run by Arrowhead Pharmaceuticals at 24 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mixed Dyslipidemia
- What is being tested?
- ARO-ANG3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 24 sitesin 4 countries
- Study dates
- 28 Jun 2021to 25 Sep 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
24 sites in 4 countries.
24 sites in 4 countries
United States13 sites
Research Site 4
Camp Hill, Pennsylvania, 17011
Research Site 15
Greensboro, North Carolina, 27408
Research Site 7
Hialeah, Florida, 33012
Research Site 11
Houston, Texas, 77030
Research Site 5
Huntington Park, California, 90255
Research Site 23
Las Vegas, Nevada, 89121
Research Site 1
Marion, Ohio, 43302
Research Site 17
Miami, Florida, 33144
Research Site 24
Minneapolis, Minnesota, 55455
Research Site 2
Morehead City, North Carolina, 28557
Research Site 22
New York, New York, 10029
Research Site 10
Omaha, Nebraska, 68114
Research Site 8
Port Orange, Florida, 32127
Canada4 sites
Research Site 16
Chicoutimi, Quebec, G7H 7K9
Research Site 25
London, Ontario, N6A 5A5
Research Site 12
Québec, G1G 3Z4
Research Site 9
Québec, H7T2P5
New Zealand4 sites
Research Site 19
Birkenhead, 0626
Research Site 13
Christchurch, 8011
Research Site 20
Hamilton, 3200
Research Site 14
Rotorua, 3010
Australia3 sites
Research Site 6
Blacktown, New South Wales, 2148
Research Site 18
Nedlands, 6009
Research Site 21
Sippy Downs, Queensland, 4556
About this study
Official title: 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.
- Conditions
- Mixed Dyslipidemia
- Being tested
- ARO-ANG3, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARO-ANG3Drug
ARO-ANG3 Injection
PlaceboDrug
Sterile Normal Saline (0.9% NaCl)
| Study group | Role | What they receive |
|---|---|---|
| ARO-ANG3 50 mg | Experimental | 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. Receives: Drug: ARO-ANG3 |
| ARO-ANG3 100 mg | Experimental | 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. Receives: Drug: ARO-ANG3 |
| ARO-ANG3 200 mg | Experimental | 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. Receives: Drug: ARO-ANG3 |
| Placebo | Placebo comparator | 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. Receives: Drug: ARO-ANG3; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Fasting TG at Week 24
Measured: Baseline, Week 24
Secondary outcomes (21)
Percent Change From Baseline in Fasting TG Over Time
Measured: Baseline, up to Week 36 (double-blind treatment period)
Percent Change From Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 24
Measured: Baseline, Week 24
Percent Change From Baseline in Fasting Non-HDL-C Over Time
Measured: Baseline, up to Week 36 (double-blind treatment period)
Percent Change From Baseline in Fasting Total Apolipoprotein B (ApoB) at Week 24
Measured: Baseline, Week 24
Percent Change From Baseline in Fasting Total ApoB Over Time
Measured: Baseline, up to Week 36 (double-blind treatment period)
Percent Change From Baseline in Fasting Low-density Lipoprotein-Cholesterol (LDL-C) Using Ultracentrifugation at Week 24
Measured: Baseline, Week 24
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time
Measured: Baseline, up to Week 36 (double-blind treatment period)
Percent Change From Baseline in Angiopoietin-like Protein 3 (ANGPTL3) at Week 24
Measured: Baseline, Week 24
Percent Change From Baseline in ANGPTL3 Over Time
Measured: Baseline, up to Week 36 (double-blind treatment period)
Percent Change From Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) at Week 24
Measured: Baseline, Week 24
Percent Change From Baseline in Fasting HDL-C Over Time
Measured: Baseline, up to Week 36 (double-blind treatment period)
Plasma Pharmacokinetic (PK) Concentration for ARO-ANG3 Over Time in the Double-Blind Treatment Period
Measured: 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 Treatment Emergent Adverse Events (TEAEs) and/or Serious TEAEs 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.
Measured: From first dose of IP up to Week 24
Number of Participants With TEAEs and/or SAEs Over Time in the 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.
Measured: 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
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, OLE Baseline, Months 1-24 (open-label extension)
Percent Change From Baseline in ANGPTL3 Over Time in the Open Label Extension (OLE) Period
Measured: 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
Measured: Baseline, OLE Baseline, Months 1-24 (open-label extension)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start28 Jun 2021
- Primary completion30 Aug 2022
- Study completion25 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mixed DyslipidemiaStudies of the same condition, open and under way.
- More trials run by Arrowhead PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arrowhead Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04832971
- Sponsor's protocol ID
- AROANG3-2001
- Acronym
- ARCHES-2
- Status last verified
- Dec 2025
- First submitted
- 2 Apr 2021
- Last updated
- 3 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rosenson RS, Gaudet D, Ballantyne CM, Nicholls SJ, Lucas KJ, Leeper NJ, Zhou R, Aiyer L, Hellawell J, Watts GF. Longer-Term Efficacy and Safety of Zodasiran in Patients with Mixed Hyperlipidaemia. Eur J Prev Cardiol. 2026 Jul 24:zwag376. doi: 10.1093/eurjpc/zwag376. Online ahead of print.
PubMed 42496147Rosenson RS, Gaudet D, Hegele RA, Ballantyne CM, Nicholls SJ, Lucas KJ, San Martin J, Zhou R, Muhsin M, Chang T, Hellawell J, Watts GF; ARCHES-2 Trial Team. Zodasiran, an RNAi Therapeutic Targeting ANGPTL3, for Mixed Hyperlipidemia. N Engl J Med. 2024 Sep 12;391(10):913-925. doi: 10.1056/NEJMoa2404147. Epub 2024 May 29.
PubMed 38809174Dimitriadis K, Theofilis P, Iliakis P, Pyrpyris N, Dri E, Sakalidis A, Soulaidopoulos S, Tsioufis P, Fragkoulis C, Chrysohoou C, Tsiachris D, Tsioufis K. Management of dyslipidemia in coronary artery disease: the present and the future. Coron Artery Dis. 2024 Sep 1;35(6):516-524. doi: 10.1097/MCA.0000000000001375. Epub 2024 Apr 29.
PubMed 38682459
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled Phase 2b Study to Evaluate the Efficacy and Safety of ARO-ANG3 in Adults With Mixed Dyslipidemia
- ClinicalTrials.gov ID
- NCT04832971
- Acronym / sponsor ID
- ARCHES-2 / AROANG3-2001
- Conditions
- Mixed Dyslipidemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Arrowhead PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 6 Apr 2021 (actual)
- Results
- Posted 16 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ARO-ANG3 50 mg | Experimental | Drug: ARO-ANG3Two 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. |
| ARO-ANG3 100 mg | Experimental | Drug: ARO-ANG3Two 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. |
| ARO-ANG3 200 mg | Experimental | Drug: ARO-ANG3Two 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. |
| Placebo | Placebo comparator | Drug: ARO-ANG3, Drug: PlaceboCalculated 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARO-ANG3ARO-ANG3 Injection | Drug | ARO-ANG3 100 mg, ARO-ANG3 200 mg, ARO-ANG3 50 mg, Placebo |
| PlaceboSterile Normal Saline (0.9% NaCl) | Drug | Placebo |
Primary outcome
Percent Change From Baseline in Fasting TG at Week 24
Time frame: Baseline, Week 24
21 secondary outcomes
Percent Change From Baseline in Fasting TG Over Time
Time frame: Baseline, up to Week 36 (double-blind treatment period)
Percent Change From Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 24
Time frame: Baseline, Week 24
Percent Change From Baseline in Fasting Non-HDL-C Over Time
Time frame: Baseline, up to Week 36 (double-blind treatment period)
Percent Change From Baseline in Fasting Total Apolipoprotein B (ApoB) at Week 24
Time frame: Baseline, Week 24
Percent Change From Baseline in Fasting Total ApoB Over Time
Time frame: Baseline, up to Week 36 (double-blind treatment period)
Percent Change From Baseline in Fasting Low-density Lipoprotein-Cholesterol (LDL-C) Using Ultracentrifugation at Week 24
Time frame: Baseline, Week 24
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time
Time frame: Baseline, up to Week 36 (double-blind treatment period)
Percent Change From Baseline in Angiopoietin-like Protein 3 (ANGPTL3) at Week 24
Time frame: Baseline, Week 24
Percent Change From Baseline in ANGPTL3 Over Time
Time frame: Baseline, up to Week 36 (double-blind treatment period)
Percent Change From Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) at Week 24
Time frame: Baseline, Week 24
Percent Change From Baseline in Fasting HDL-C Over Time
Time frame: 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)
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
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42496147Rosenson RS, Gaudet D, Ballantyne CM, Nicholls SJ, Lucas KJ, Leeper NJ, Zhou R, Aiyer L, Hellawell J, Watts GF. Longer-Term Efficacy and Safety of Zodasiran in Patients with Mixed Hyperlipidaemia. Eur J Prev Cardiol. 2026 Jul 24:zwag376. doi: 10.1093/eurjpc/zwag376. Online ahead of print.
- Derived from this study: PubMed 38809174Rosenson RS, Gaudet D, Hegele RA, Ballantyne CM, Nicholls SJ, Lucas KJ, San Martin J, Zhou R, Muhsin M, Chang T, Hellawell J, Watts GF; ARCHES-2 Trial Team. Zodasiran, an RNAi Therapeutic Targeting ANGPTL3, for Mixed Hyperlipidemia. N Engl J Med. 2024 Sep 12;391(10):913-925. doi: 10.1056/NEJMoa2404147. Epub 2024 May 29.
- Derived from this study: PubMed 38682459Dimitriadis K, Theofilis P, Iliakis P, Pyrpyris N, Dri E, Sakalidis A, Soulaidopoulos S, Tsioufis P, Fragkoulis C, Chrysohoou C, Tsiachris D, Tsioufis K. Management of dyslipidemia in coronary artery disease: the present and the future. Coron Artery Dis. 2024 Sep 1;35(6):516-524. doi: 10.1097/MCA.0000000000001375. Epub 2024 Apr 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ARO-ANG3 in people with Mixed Dyslipidemia, run by Arrowhead Pharmaceuticals at 24 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Canada, New Zealand, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in Fasting TG at Week 24 (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04832971, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.