Hyperlipidemia; MixedPhase 1/2NCT07223658
Study of ARO-DIMERPA in Adult Participants With Mixed Hyperlipidemia
A Phase 1/2 study testing ARO-DIMERPA in people with Hyperlipidemia; Mixed, run by Arrowhead Pharmaceuticals at 19 sites in 5 countries.
Trial summary
Study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD), and effects on low-density lipoprotein cholesterol (LDL-C) and triglycerides (TGs) of single-dose ARO-DIMERPA and multiple doses of ARO-DIMERPA in adult participants with mixed hyperlipidemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperlipidemia; Mixed
- What is being tested?
- ARO-DIMERPA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 19 sitesin 5 countries
- Study dates
- 22 Dec 2025to Jul 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Willing to follow diet counseling as per Investigator judgment based on local standard of care
- Specific fasting TG, LDL-C, and non-high density lipoprotein cholesterol levels at Screening
- Participants of childbearing potential must agree to use highly effective contraception in addition to a condom during the study and for at least 90 days following the end of the study or last dose of study drug, whichever is later; participants must not donate sperm or eggs during the study and for at least 90 days following the end of the study or last dose of study drug whichever is later
Who cannot join
- Current use or use within last 365 days or within 5-half-lives before Day 1 based on plasma PK, whichever is longer, of any hepatocyte-targeted siRNA
- Current use or use within last 90 days or within 5-half-lives before Day 1 based on plasma PK, whichever is longer, of any antisense oligonucleotide therapy
- Current use or use within last 60 days from Day 1 of any PCSK9 inhibitor monoclonal antibodies (eg, evolocumab or alirocumab)
- Uncontrolled hypertension
- History of bleeding diathesis or coagulopathy
- Current diagnosis of nephrotic syndrome
- Note: Additional inclusion/exclusion criteria may apply per protocol.
Trial locations and contacts
19 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
19 sites in 5 countries
Australia6 sites, 6 recruiting
- Recruiting
Research Site 7
Charlestown, New South Wales, 2290
- Recruiting
Research Site 11
Clayton, 3168
- Recruiting
Research Site 8
East Melbourne, Victoria, 3002
- Recruiting
Research Site 4
Melbourne, Victoria, 3153
- Recruiting
Research Site 5
Morayfield, Queensland, 4506
- Recruiting
Research Site 9
Perth, Western Australia, 6009
New Zealand5 sites, 5 recruiting
- Recruiting
Research Site 3
Auckland, 2025
- Recruiting
Research Site 2
Auckland, 622
- Recruiting
Research Site 1
Christchurch, 8011
- Recruiting
Research Site 6
Grafton, Auckland, 1023
- Recruiting
Research Site 12
Wellington, 6021
Canada4 sites, 4 recruiting
- Recruiting
Research Site 17
Chicoutimi, G7H 7K9
- Recruiting
Research Site
Penticton, British Columbia, V2A 5L5
- Recruiting
Research Site 16
Toronto, M1S 3V6
- Recruiting
Research Site
Toronto, M4G 3E8
Georgia3 sites, 3 recruiting
- Recruiting
Research Site 13
Tbilisi, 102
- Recruiting
Research Site 14
Tbilisi, 144
- Recruiting
Research Site 15
Tbilisi, 191
About this study
Official title: Phase 1/2a, Double-blind, Placebo-controlled, Single and Multiple Dose-escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of ARO-DIMERPA in Adult Subjects With Mixed Hyperlipidemia
Study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD), and effects on low-density lipoprotein cholesterol (LDL-C) and triglycerides (TGs) of single-dose ARO-DIMERPA and multiple doses of ARO-DIMERPA in adult participants with mixed hyperlipidemia.
- Conditions
- Hyperlipidemia; Mixed
- Being tested
- ARO-DIMERPA, Placebo
- Medical subject headings
- Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARO-DIMERPADrug
Subcutaneous (SC) injection
PlaceboDrug
Calculated volume to match active treatment by SC injection
| Study group | Role | What they receive |
|---|---|---|
| ARO-DIMERPA | Experimental | ARO-DIMERPA in single or multiple ascending doses Receives: Drug: ARO-DIMERPA |
| Placebo | Placebo comparator | Placebo (normal saline, 0.9%) in single or multiple matching doses Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to Week 36
Secondary outcomes (15)
Percent Change from Baseline in Fasting LDL-C
Measured: Baseline to Week 36
Percent Change from Baseline in Fasting TGs
Measured: Baseline to Week 36
Percent Change from Baseline in Serum apoC-III
Measured: Baseline to Week 36
Percent Change from Baseline in Serum PCSK9
Measured: Baseline to Week 36
PK of ARO-DIMERPA: Maximum Observed Plasma Concentration (Cmax)
Measured: Through 24 hours postdose
PK of ARO-DIMERPA: Time to Maximum Plasma Concentration (Tmax)
Measured: Through 24 hours postdose
PK of ARO-DIMERPA: Area Under the Plasma Concentration (AUC) Versus Time Curve From Time Zero to 24 Hours (AUC0-24)
Measured: Through 24 hours postdose
PK of ARO-DIMERPA: AUC Versus Time Curve From Time Zero to the Last Quantifiable Plasma Concentration (AUC0-t)
Measured: Through 24 hours postdose
PK of ARO-DIMERPA: AUC Versus Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf)
Measured: Through 24 hours postdose
PK of ARO-DIMERPA: Apparent Terminal Elimination Half-life (t1/2)
Measured: Through 24 hours postdose
PK of ARO-DIMERPA: Apparent Systemic Clearance (CL/F)
Measured: Through 24 hours postdose
PK of ARO-DIMERPA: Apparent Terminal-phase Volume of Distribution (Vz/F)
Measured: Through 24 hours postdose
PK of ARODIMERPA: Recovery of Unchanged Drug (Ae) in Urine From Time Zero to 24 Hours Postdose
Measured: Through 24 hours postdose
PK of ARO-DIMERPA: Percentage of Administered Drug Recovered (Fe) in Urine From Time Zero to 24 Hours Postdose
Measured: Through 24 hours postdose
PK of ARO-DIMERPA: Renal Clearance (CLR)
Measured: Through 24 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2025
- Study start22 Dec 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperlipidemia; MixedStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arrowhead Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07223658
- Sponsor's protocol ID
- ARODIMERPA-1001
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2a, Double-blind, Placebo-controlled, Single and Multiple Dose-escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of ARO-DIMERPA in Adult Subjects With Mixed Hyperlipidemia
- ClinicalTrials.gov ID
- NCT07223658
- Acronym / sponsor ID
- ARODIMERPA-1001
- Conditions
- Hyperlipidemia; Mixed
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Arrowhead PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 3 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD), and effects on low-density lipoprotein cholesterol (LDL-C) and triglycerides (TGs) of single-dose ARO-DIMERPA and multiple doses of ARO-DIMERPA in adult participants with mixed hyperlipidemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARO-DIMERPA | Experimental | Drug: ARO-DIMERPAARO-DIMERPA in single or multiple ascending doses |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (normal saline, 0.9%) in single or multiple matching doses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willing to follow diet counseling as per Investigator judgment based on local standard of care
- Specific fasting TG, LDL-C, and non-high density lipoprotein cholesterol levels at Screening
- Participants of childbearing potential must agree to use highly effective contraception in addition to a condom during the study and for at least 90 days following the end of the study or last dose of study drug, whichever is later; participants must not donate sperm or eggs during the study and for at least 90 days following the end of the study or last dose of study drug whichever is later
Key exclusion criteria (7 listed)
- Current use or use within last 365 days or within 5-half-lives before Day 1 based on plasma PK, whichever is longer, of any hepatocyte-targeted siRNA
- Current use or use within last 90 days or within 5-half-lives before Day 1 based on plasma PK, whichever is longer, of any antisense oligonucleotide therapy
- Current use or use within last 60 days from Day 1 of any PCSK9 inhibitor monoclonal antibodies (eg, evolocumab or alirocumab)
- Uncontrolled hypertension
- History of bleeding diathesis or coagulopathy
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-DIMERPASubcutaneous (SC) injection | Drug | ARO-DIMERPA |
| PlaceboCalculated volume to match active treatment by SC injection | Drug | Placebo |
Primary outcome
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Week 36
15 secondary outcomes
Percent Change from Baseline in Fasting LDL-C
Time frame: Baseline to Week 36
Percent Change from Baseline in Fasting TGs
Time frame: Baseline to Week 36
Percent Change from Baseline in Serum apoC-III
Time frame: Baseline to Week 36
Percent Change from Baseline in Serum PCSK9
Time frame: Baseline to Week 36
PK of ARO-DIMERPA: Maximum Observed Plasma Concentration (Cmax)
Time frame: Through 24 hours postdose
PK of ARO-DIMERPA: Time to Maximum Plasma Concentration (Tmax)
Time frame: Through 24 hours postdose
PK of ARO-DIMERPA: Area Under the Plasma Concentration (AUC) Versus Time Curve From Time Zero to 24 Hours (AUC0-24)
Time frame: Through 24 hours postdose
PK of ARO-DIMERPA: AUC Versus Time Curve From Time Zero to the Last Quantifiable Plasma Concentration (AUC0-t)
Time frame: Through 24 hours postdose
PK of ARO-DIMERPA: AUC Versus Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf)
Time frame: Through 24 hours postdose
PK of ARO-DIMERPA: Apparent Terminal Elimination Half-life (t1/2)
Time frame: Through 24 hours postdose
PK of ARO-DIMERPA: Apparent Systemic Clearance (CL/F)
Time frame: Through 24 hours postdose
PK of ARO-DIMERPA: Apparent Terminal-phase Volume of Distribution (Vz/F)
Time frame: Through 24 hours postdose
PK of ARODIMERPA: Recovery of Unchanged Drug (Ae) in Urine From Time Zero to 24 Hours Postdose
Time frame: Through 24 hours postdose
PK of ARO-DIMERPA: Percentage of Administered Drug Recovered (Fe) in Urine From Time Zero to 24 Hours Postdose
Time frame: Through 24 hours postdose
PK of ARO-DIMERPA: Renal Clearance (CLR)
Time frame: Through 24 hours postdose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Randomized Controlled Trial of Alert-Based Computerized Decision Support for Optimizing Low-Density Lipoprotein Management
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Not yet recruitingPhase 3
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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.
19 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ARO-DIMERPA in people with Hyperlipidemia; Mixed, run by Arrowhead Pharmaceuticals at 19 sites in 5 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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Australia, New Zealand, Canada, Georgia, Moldova. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical Monitor (626-304-3400, ARODIMERPA-1001@arrowheadpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) (time frame: Up to Week 36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2026.