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
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