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New injection aims to tame liver Scarring—First human trial underway

NCT ID NCT05490888

Disease control Sponsor: PharmaIN Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This early-stage trial is testing a new drug called PHIN-214 (a modified version of terlipressin) in 74 adults with mild-to-moderate liver cirrhosis. The study has two parts: a single dose and then daily injections for 28 days. The main goals are to check safety, find the best dose, and see how the body processes the drug. It is not yet testing whether the drug actually improves liver health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PHIN-214 (a terlipressin derivative given as a subcutaneous injection)
What this could lead to
If successful, this could point toward a new treatment option to manage cirrhosis and reduce complications like fluid buildup (ascites).
What could go wrong
This is an early phase 1 trial with only 74 participants, focused on safety and dosing—not yet testing effectiveness. The drug may cause side effects or not work as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 74 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2022

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. History of cirrhosis based on histology or a combination of clinical, radiological, or biochemical assessment and classified as Child-Pugh A or B 2. Participants may be male or female aged 18 to 75 years. 3. Body mass index (BMI) within the range 18 to 40 kg/m2 (inclusive) at screening. 4. Female participants must be non-pregnant, non-lactating, or of non-childbearing potential or using highly efficient contraception for the full duration of the study Key Exclusion Criteria: 1. Significant abnormalities in medical history or on physical examination, including: respiratory disease requiring therapy or history of respiratory failure, cardiovascular disease or hypertension, electrocardiogram abnormalities or history of significant EKG abnormalities. 2. History of diabetes insipidus, syndrome of inappropriate antidiuretic hormone secretion, or any other disorder associated with fluid or sodium imbalance. 3. Significant kidney disease 4. Hepatic encephalopathy (HE) or altered mental status requiring hospitalization; variceal bleeding or upper gastrointestinal bleeding; or type 1 hepatorenal syndrome with acute kidney injury (HRS-AKI) during the previous 3 months prior to Screening. 5. Acute-on-chronic liver failure. 6. Recipient of a patent transjugular intrahepatic portosystemic shunt (TIPS). 7. Known positive HIV serology confirmed by HIV viral load. 8. Subjects with acute infections, including acute viral hepatitis (subjects with chronic hepatitis B are eligible if treatment regimen is stable ≥ 3 months prior to study inclusion).

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Conditions

The condition(s) this trial relates to.

Ascites cirrhosis of liver Fibrosis fibrotic liver disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ascites hepatic Cirrhosis, liver Liver fibrosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    9 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Arizona Liver Health

    RECRUITING

    Chandler, Arizona, 85224, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Methodist Health System, Dallas Medical Center

    RECRUITING

    Dallas, Texas, 75203, United States

    Contact Email: •••••@•••••

  • Southern California Research Center

    RECRUITING

    Coronado, California, 92118, United States

  • Tandem Clinical Research

    RECRUITING

    Marrero, Louisiana, 70072, United States

  • Texas Liver Institute

    RECRUITING

    San Antonio, Texas, 78215, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • VA North Texas Healthcare System

    RECRUITING

    Dallas, Texas, 75216, United States

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