Health TrialsbyHealthPanel

Study of ARO-DIMERPA in Adult Participants With Mixed Hyperlipidemia

ConditionHyperlipidemia; Mixed
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorArrowhead Pharmaceuticals

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • ARO-DIMERPA

    Drug

    Subcutaneous (SC) injection

  • Placebo

    Drug

    Calculated volume to match active treatment by SC injection

Treatment groups

78 Participants
are divided into 2 treatment groups
Group A: ARO-DIMERPAExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

Time frame
Up to Week 36

Secondary outcomes

1

Percent Change from Baseline in Fasting LDL-C

Time frame
Baseline to Week 36
2

Percent Change from Baseline in Fasting TGs

Time frame
Baseline to Week 36
3

Percent Change from Baseline in Serum apoC-III

Time frame
Baseline to Week 36
4

Percent Change from Baseline in Serum PCSK9

Time frame
Baseline to Week 36

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Arrowhead Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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