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Recruiting NCT07223658

Study of ARO-DIMERPA in Adult Participants With Mixed Hyperlipidemia

Phase I / Phase II Interventional Hyperlipidemia; Mixed

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ARO-DIMERPA, Placebo.
Who it may be relevant to
Registry conditions: Hyperlipidemia; Mixed. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia, Canada, Georgia, New Zealand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug ARO-DIMERPA
    Subcutaneous (SC) injection
  • Drug Placebo
    Calculated volume to match active treatment by SC injection

Primary outcome measures

  • Number of Participants with Treatment-Emergent Adverse Events (TEAEs) [Time frame: Up to Week 36]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Australia · 6 centers
  • Research Site 7 — Charlestown
  • Research Site 5 — Morayfield
  • Research Site 8 — East Melbourne
  • Research Site 4 — Melbourne
  • Research Site 9 — Perth
  • Research Site 11 — Clayton
New Zealand · 5 centers
  • Research Site 6 — Grafton
  • Research Site 3 — Auckland
  • Research Site 2 — Auckland
  • Research Site 1 — Christchurch
  • Research Site 12 — Wellington
Georgia · 3 centers
  • Research Site 13 — Tbilisi
  • Research Site 14 — Tbilisi
  • Research Site 15 — Tbilisi
Canada · 1 center
  • Research Site 10 — Calgary

Identifiers

NCT: NCT07223658 · ARODIMERPA-1001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗