Non-alcoholic SteatohepatitisPhase 1/2NCT04202354

Study of ARO-HSD in Healthy Volunteers and Patients With Non-Alcoholic Steatohepatitis (NASH) or Suspected NASH

A Phase 1/2 study testing ARO-HSD Injection and sterile normal saline (0.9% NaCl) in people with Non-alcoholic Steatohepatitis, run by Arrowhead Pharmaceuticals at 1 site in New Zealand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of single and multiple doses of ARO-HSD in healthy adult volunteers and in patients with NASH or suspected NASH. Read more about this study

Who is it for?: Ages 19 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Non-alcoholic Steatohepatitis
What is being tested?: ARO-HSD Injection and sterile normal saline (0.9% NaCl)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 1 siteNew Zealand
Study dates: 3 Mar 2020to 3 Sep 2021
Phase: Phase 1/2
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 19 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Women of child bearing potential must have a negative pregnancy test, cannot be breastfeeding and must be willing to use contraception
Willing to provide written informed consent and to comply with study requirements
On a stable diet for at least 4 weeks with no plans to significantly alter diet or weight over course of study
Normal electrocardiogram (ECG) at Screening
No abnormal finding of clinical relevance (other than NASH, suspected NASH in patients) at Screening that could adversely impact subject safety during the study or adversely impact study results.

Who cannot join

Clinically significant health concerns (other than NASH, suspected NASH in patients)
Human immunodeficiency virus (HIV) infection, seropositive for Hepatitis B Virus (HBV), seropositive for Hepatitis C Virus (HCV)
Uncontrolled hypertension
Excessive use of alcohol within three months prior to Screening
Use of illicit drugs within 1 year prior to Screening, or positive urine drug screen at Screening
Use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study

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NOTE: additional inclusion/exclusion criteria may apply, per protocol
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Trial locations and contacts

1 site in 1 country.

New Zealand1 site

Auckland Clinical Studies
Grafton, Auckland, 1010

Other trials in New Zealand

About this study

Official title: A Phase 1/2a Single and Multiple Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of ARO-HSD in Normal Healthy Volunteers as Well as in Patients With NASH or Suspected NASH

Conditions: Non-alcoholic Steatohepatitis
Being tested: ARO-HSD Injection, sterile normal saline (0.9% NaCl)
Medical subject headings: Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ARO-HSD InjectionDrug
single or multiple doses of ARO-HSD by subcutaneous (sc) injections
sterile normal saline (0.9% NaCl)Drug
calculated volume to match active treatment, by sc injection

Study groups in NCT04202354
Study group	Role	What they receive
Cohort 1: ARO-HSD 25 mg	Experimental	Normal healthy volunteers randomized to double blind ARO-HSD 25 mg on Day 1 only. Receives: Drug: ARO-HSD Injection
Cohort 1: Placebo	Placebo comparator	Normal healthy volunteers randomized to double blind placebo on Day 1 only. Receives: Drug: sterile normal saline (0.9% NaCl)
Cohort 2: ARO-HSD 50 mg	Experimental	Normal healthy volunteers randomized to double blind ARO-HSD 50 mg on Day 1 only. Receives: Drug: ARO-HSD Injection
Cohort 2: Placebo	Placebo comparator	Normal healthy volunteers randomized to double blind placebo on Day 1 only. Receives: Drug: sterile normal saline (0.9% NaCl)
Cohort 3: ARO-HSD 100 mg	Experimental	Normal healthy volunteers randomized to double blind ARO-HSD 100 mg on Day 1 only. Receives: Drug: ARO-HSD Injection
Cohort 3: Placebo	Placebo comparator	Normal healthy volunteers randomized to double blind placebo on Day 1 only. Receives: Drug: sterile normal saline (0.9% NaCl)
Cohort 4: ARO-HSD 200 mg	Experimental	Normal healthy volunteers randomized to double blind ARO-HSD 200 mg on Day 1 only. Receives: Drug: ARO-HSD Injection
Cohort 4: Placebo	Placebo comparator	Normal healthy volunteers randomized to double blind placebo on Day 1 only. Receives: Drug: sterile normal saline (0.9% NaCl)
Cohort 1b: ARO-HSD 25 mg	Experimental	Participants with suspected non-alcoholic steatohepatitis (NASH) receive open-label ARO-HSD 25 mg on Days 1 and 29. Receives: Drug: ARO-HSD Injection
Cohort 3b: ARO-HSD 100 mg	Experimental	Participants with suspected NASH receive open-label ARO-HSD 100 mg on Days 1 and 29. Receives: Drug: ARO-HSD Injection
Cohort 4b: ARO-HSD 200 mg	Experimental	Participants with suspected NASH receive open-label ARO-HSD 200 mg on Days 1 and 29. Receives: Drug: ARO-HSD Injection

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) Possibly or Probably Related to Treatment
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 through Day 113 (±5 days)

Secondary outcomes (11)

Pharmacokinetics (PK) of ARO-HSD: Plasma Concentrations
Measured: Normal Healthy Volunteers: Day 1: 2 hours pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 8, 12, 18, 24; Day 2: 48 hours post-dose, Days 8, 15, 29. NASH Participants: Day 1: 2 hours pre-dose, 30 minutes, 1, 2, 24, hours post-dose, Days 8, 15, 29
PK of ARO-HSD in Normal Healthy Volunteers: Maximum Observed Plasma Concentration (Cmax)
Measured: Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24, 48 hours postdose
PK of ARO-HSD in Normal Healthy Volunteers: Time to Reach Cmax (Tmax)
Measured: Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24, 48 hours postdose
PK of ARO-HSD in Normal Healthy Volunteers: Terminal Elimination Half-Life (t1/2)
Measured: Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24, 48 hours postdose
PK of ARO-HSD in Normal Healthy Volunteers: Area Under the Concentration-Time Curve From Dosing (Time 0) to the Time of the Last Measured Concentration (AUClast)
Measured: Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24, 48 hours postdose
PK of ARO-HSD in Normal Healthy Volunteers: Area Under the Curve From Time 0 to Infinity (AUCinf)
Measured: Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24, 48 hours postdose
Secondary: PK of ARO-HSD in Normal Healthy Volunteers: Oral Clearance (CL/F)
Measured: Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24, 48 hours postdose
PK of ARO-HSD in Normal Healthy Volunteers: Apparent Volume of Distribution During the Terminal-Phase (Vz/F)
Measured: Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24, 48 hours postdose
Urine PK of ARO-HSD in Normal Healthy Volunteers: Amount of Unchanged Drug Recovered in Urine Over 0-24 Hours Postdose (Ae0-24h)
Measured: Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24 hours postdose
Urine PK of ARO-HSD in Normal Healthy Volunteers: Percentage of the Administrated Drug Recovered in Urine Over 0-24 Hours (Fe0-24h)
Measured: Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24 hours postdose
Urine PK of ARO-HSD in Normal Healthy Volunteers: Renal Clearance (CLr)
Measured: Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24 hours postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Mar 20203 Sep 2021

First posted17 Dec 2019
Study start3 Mar 2020
Primary completion3 Sep 2021
Study completion3 Sep 2021

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 (1)Papers the sponsor has linked to this study.
Other trials for Non-alcoholic SteatohepatitisStudies 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: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04202354
Sponsor's protocol ID: AROHSD1001
Status last verified: Sep 2025
First submitted: 16 Dec 2019
Last updated: 3 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Mak LY, Gane E, Schwabe C, Yoon KT, Heo J, Scott R, Lee JH, Lee JI, Kweon YO, Weltman M, Harrison SA, Neuschwander-Tetri BA, Cusi K, Loomba R, Given BD, Christianson DR, Garcia-Medel E, Yi M, Hamilton J, Yuen MF. A phase I/II study of ARO-HSD, an RNA interference therapeutic, for the treatment of non-alcoholic steatohepatitis. J Hepatol. 2023 Apr;78(4):684-692. doi: 10.1016/j.jhep.2022.11.025. Epub 2022 Dec 10.
PubMed 36513186

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Non-alcoholic Steatohepatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2a Single and Multiple Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of ARO-HSD in Normal Healthy Volunteers as Well as in Patients With NASH or Suspected NASH
ClinicalTrials.gov ID: NCT04202354
Acronym / sponsor ID: AROHSD1001
Conditions: Non-alcoholic Steatohepatitis
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Arrowhead PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 3 Mar 2020 (actual)
Primary completion: 3 Sep 2021 (actual)
Study completion: 3 Sep 2021 (actual)
First posted: 17 Dec 2019 (actual)
Results: Posted 3 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 11

Arm	Type	Receives
Cohort 1: ARO-HSD 25 mg	Experimental	Drug: ARO-HSD InjectionNormal healthy volunteers randomized to double blind ARO-HSD 25 mg on Day 1 only.
Cohort 1: Placebo	Placebo comparator	Drug: sterile normal saline (0.9% NaCl)Normal healthy volunteers randomized to double blind placebo on Day 1 only.
Cohort 2: ARO-HSD 50 mg	Experimental	Drug: ARO-HSD InjectionNormal healthy volunteers randomized to double blind ARO-HSD 50 mg on Day 1 only.
Cohort 2: Placebo	Placebo comparator	Drug: sterile normal saline (0.9% NaCl)Normal healthy volunteers randomized to double blind placebo on Day 1 only.
Cohort 3: ARO-HSD 100 mg	Experimental	Drug: ARO-HSD InjectionNormal healthy volunteers randomized to double blind ARO-HSD 100 mg on Day 1 only.
Cohort 3: Placebo	Placebo comparator	Drug: sterile normal saline (0.9% NaCl)Normal healthy volunteers randomized to double blind placebo on Day 1 only.
Cohort 4: ARO-HSD 200 mg	Experimental	Drug: ARO-HSD InjectionNormal healthy volunteers randomized to double blind ARO-HSD 200 mg on Day 1 only.
Cohort 4: Placebo	Placebo comparator	Drug: sterile normal saline (0.9% NaCl)Normal healthy volunteers randomized to double blind placebo on Day 1 only.
Cohort 1b: ARO-HSD 25 mg	Experimental	Drug: ARO-HSD InjectionParticipants with suspected non-alcoholic steatohepatitis (NASH) receive open-label ARO-HSD 25 mg on Days 1 and 29.
Cohort 3b: ARO-HSD 100 mg	Experimental	Drug: ARO-HSD InjectionParticipants with suspected NASH receive open-label ARO-HSD 100 mg on Days 1 and 29.
Cohort 4b: ARO-HSD 200 mg	Experimental	Drug: ARO-HSD InjectionParticipants with suspected NASH receive open-label ARO-HSD 200 mg on Days 1 and 29.

Who may qualify

Ages: 19 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Women of child bearing potential must have a negative pregnancy test, cannot be breastfeeding and must be willing to use contraception
Willing to provide written informed consent and to comply with study requirements
On a stable diet for at least 4 weeks with no plans to significantly alter diet or weight over course of study
Normal electrocardiogram (ECG) at Screening
No abnormal finding of clinical relevance (other than NASH, suspected NASH in patients) at Screening that could adversely impact subject safety during the study or adversely impact study results.

Key exclusion criteria (9 listed)

Clinically significant health concerns (other than NASH, suspected NASH in patients)
Human immunodeficiency virus (HIV) infection, seropositive for Hepatitis B Virus (HBV), seropositive for Hepatitis C Virus (HCV)
Uncontrolled hypertension
Excessive use of alcohol within three months prior to Screening
Use of illicit drugs within 1 year prior to Screening, or positive urine drug screen at Screening

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-HSD Injectionsingle or multiple doses of ARO-HSD by subcutaneous (sc) injections	Drug	Cohort 1: ARO-HSD 25 mg, Cohort 1b: ARO-HSD 25 mg, Cohort 2: ARO-HSD 50 mg, Cohort 3: ARO-HSD 100 mg, Cohort 3b: ARO-HSD 100 mg, Cohort 4: ARO-HSD 200 mg, Cohort 4b: ARO-HSD 200 mg
sterile normal saline (0.9% NaCl)calculated volume to match active treatment, by sc injection	Drug	Cohort 1: Placebo, Cohort 2: Placebo, Cohort 3: Placebo, Cohort 4: Placebo

Primary outcome

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment
Time frame: From first dose of study drug through Day 113 (±5 days)
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.

11 secondary outcomes

Pharmacokinetics (PK) of ARO-HSD: Plasma Concentrations
Time frame: Normal Healthy Volunteers: Day 1: 2 hours pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 8, 12, 18, 24; Day 2: 48 hours post-dose, Days 8, 15, 29. NASH Participants: Day 1: 2 hours pre-dose, 30 minutes, 1, 2, 24, hours post-dose, Days 8, 15, 29
PK of ARO-HSD in Normal Healthy Volunteers: Maximum Observed Plasma Concentration (Cmax)
Time frame: Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24, 48 hours postdose
PK of ARO-HSD in Normal Healthy Volunteers: Time to Reach Cmax (Tmax)
Time frame: Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24, 48 hours postdose
PK of ARO-HSD in Normal Healthy Volunteers: Terminal Elimination Half-Life (t1/2)
Time frame: Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24, 48 hours postdose
PK of ARO-HSD in Normal Healthy Volunteers: Area Under the Concentration-Time Curve From Dosing (Time 0) to the Time of the Last Measured Concentration (AUClast)
Time frame: Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24, 48 hours postdose
PK of ARO-HSD in Normal Healthy Volunteers: Area Under the Curve From Time 0 to Infinity (AUCinf)
Time frame: Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24, 48 hours postdose
Secondary: PK of ARO-HSD in Normal Healthy Volunteers: Oral Clearance (CL/F)
Time frame: Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24, 48 hours postdose
PK of ARO-HSD in Normal Healthy Volunteers: Apparent Volume of Distribution During the Terminal-Phase (Vz/F)
Time frame: Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24, 48 hours postdose
Urine PK of ARO-HSD in Normal Healthy Volunteers: Amount of Unchanged Drug Recovered in Urine Over 0-24 Hours Postdose (Ae0-24h)
Time frame: Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24 hours postdose
Urine PK of ARO-HSD in Normal Healthy Volunteers: Percentage of the Administrated Drug Recovered in Urine Over 0-24 Hours (Fe0-24h)
Time frame: Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24 hours postdose
Urine PK of ARO-HSD in Normal Healthy Volunteers: Renal Clearance (CLr)
Time frame: Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24 hours postdose

Results and safety

Results posted to the registry on 3 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: ARO-HSD 25 mg	4	4
Cohort 2: ARO-HSD 50 mg	4	4
Cohort 3: ARO-HSD 100 mg	4	4
Cohort 4: ARO-HSD 200 mg	4	4
Cohorts 1-4: Pooled Placebo	16	16
Cohort 1b: ARO-HSD 25 mg	6	6
Cohort 3b: ARO-HSD 100 mg	6	6
Cohort 4b: ARO-HSD 200 mg	6	6

Primary outcome: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment

Time frame: From first dose of study drug through Day 113 (±5 days). Number. Unit: participants

Measure	Cohort 1: ARO-HSD 25 mg n = 4	Cohort 2: ARO-HSD 50 mg n = 4	Cohort 3: ARO-HSD 100 mg n = 4	Cohort 4: ARO-HSD 200 mg n = 4	Cohorts 1-4: Pooled Placebo n = 16	Cohort 1b: ARO-HSD 25 mg n = 6	Cohort 3b: ARO-HSD 100 mg n = 6	Cohort 4b: ARO-HSD 200 mg n = 6
Value	0	0	1	3	0	1	1	2

Population analysed: Safety Population: all enrolled participants who received at least one dose of active drug or placebo.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Screening through Day 113 (±5 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: ARO-HSD 25 mg	0 of 4 (0%)	4 of 4 (100%)	0 of 4
Cohort 2: ARO-HSD 50 mg	0 of 4 (0%)	1 of 4 (25%)	0 of 4
Cohort 3: ARO-HSD 100 mg	0 of 4 (0%)	4 of 4 (100%)	0 of 4
Cohort 4: ARO-HSD 200 mg	0 of 4 (0%)	3 of 4 (75%)	0 of 4
Cohorts 1-4: Pooled Placebo	0 of 16 (0%)	10 of 16 (62.5%)	0 of 16
Cohort 1b: ARO-HSD 25 mg	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Cohort 3b: ARO-HSD 100 mg	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Cohort 4b: ARO-HSD 200 mg	1 of 6 (16.7%)	4 of 6 (66.7%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36513186Mak LY, Gane E, Schwabe C, Yoon KT, Heo J, Scott R, Lee JH, Lee JI, Kweon YO, Weltman M, Harrison SA, Neuschwander-Tetri BA, Cusi K, Loomba R, Given BD, Christianson DR, Garcia-Medel E, Yi M, Hamilton J, Yuen MF. A phase I/II study of ARO-HSD, an RNA interference therapeutic, for the treatment of non-alcoholic steatohepatitis. J Hepatol. 2023 Apr;78(4):684-692. doi: 10.1016/j.jhep.2022.11.025. Epub 2022 Dec 10.
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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ARO-HSD Injection and sterile normal saline (0.9% NaCl) in people with Non-alcoholic Steatohepatitis, run by Arrowhead Pharmaceuticals at 1 site in New Zealand.

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 5 inclusion and 9 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 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in New Zealand. 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?

Yes. Results are posted in the registry (first posted 3 Oct 2025). 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?

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment (time frame: From first dose of study drug through Day 113 (±5 days)). 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 NCT04202354, which also lists 1 linked publication.

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 Oct 2025.