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Could a daily shot tame fatty liver scarring?

NCT ID NCT05364931

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 · Updated 1 time

Summary

This study tested a drug called cotadutide in 54 adults with a type of fatty liver disease that includes liver scarring but not cirrhosis. Participants received either the drug or a placebo as a daily injection. The main goal was to check safety and tolerability, with results helping to decide if larger studies are worthwhile.

What this could mean

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

Active substance
Cotadutide (a daily injection)
What this could lead to
If it works, this could point toward a treatment for NASH-related liver scarring, potentially slowing or stopping disease progression.
What could go wrong
This is a small, early-phase study focused on safety, not proof of effectiveness. The drug may not improve liver health or could cause side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

54 people

The number who actually took part.

Started

Jul 2022

Finished

Apr 2024

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.

Inclusion Criteria: 1. Provision of informed consent 2. Males and female participants ≥ 18 to ≤ 75 years of age (inclusive) at the time of signing the informed consent. 3. Histologically confirmed non-alcoholic steatohepatitis (NASH) per NASH Clinical Research Network (CRN) criteria as diagnosed by histology from a liver biopsy performed ≤ 180 days from randomization and fulfilling all of the following histological criteria: 1. NAS (Non-alcoholic Fatty Liver Disease Activity Score) ≥ 4 with a score of ≥ 1 for each component: steatosis, lobular inflammation, and ballooning 2. Presence of fibrosis stage F2 or F3 4. Women of childbearing potential, non-pregnant and nonbreastfeeding and using appropriate birth control to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of study intervention. Exclusion Criteria: 1. Chronic liver disease of other etiologies. 2. History of cirrhosis and/or hepatic decompensation, including evidence of portal hypertension (e.g. low platelet count, splenomegaly, ascites, history of hepatic encephalopathy, esophageal varices, or variceal bleeding). 3. Clinically significant cardiovascular or cerebrovascular disease within 90 days prior to screening, including but not limited to, myocardial infarction, acute coronary syndrome, unstable angina pectoris, transient ischemic attack, or stroke, or participants who have undergone percutaneous coronary intervention or a coronary artery bypass graft within the past 90 days or who are due to undergo these procedures at the time of screening 4. History of malignant neoplasms within 5 years prior to screening, except for adequately treated basal cell, squamous cell skin cancer, or any in situ carcinoma. 5. Participation in another clinical study with an investigational product administered within the last 30 days or 5 half-lives of the therapy (whichever is longer) at the time of screening or the time of the historical biopsy or concurrent participation in another interventional study of any kind or prior randomization in this study. 6. Severe allergy/hypersensitivity to any of the proposed study treatments or excipients 7. Contraindication to liver biopsy (eg, bleeding diathesis, such as hemophilia, suspected hemangioma, or suspected echinococcal infection) or inability to safely obtain a liver biopsy as determined by the investigator 8. Severely uncontrolled hypertension defined as SBP ≥ 180 mmHg or DBP ≥ 110 mmHg on the average of 2 seated BP measurements after being at rest for at least 10 minutes at screening or randomization 9 Any positive results for human immunodeficiency virus infection, positive results for hepatitis B surface antigen or hepatitis C antibody test along with a positive HCV RNA test.

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver metabolic dysfunction-associated steatohepatitis metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

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

Non-cirrhotic non-alcoholic steatohepatitis with fibrosis

Contacts and locations

Locations

  • Research Site

    Tucson, Arizona, 85712, United States

  • Research Site

    Canoga Park, California, 91303, United States

  • Research Site

    Gilroy, California, 95020, United States

  • Research Site

    Sacramento, California, 95821, United States

  • Research Site

    Englewood, Colorado, 80113, United States

  • Research Site

    Bradenton, Florida, 34208, United States

  • Research Site

    Homestead, Florida, 33032, United States

  • Research Site

    Jacksonville, Florida, 32216, United States

  • Research Site

    Miami, Florida, 33175, United States

  • Research Site

    Miami, Florida, 33176, United States

  • Research Site

    Winter Park, Florida, 32789, United States

  • Research Site

    Munster, Indiana, 46321, United States

  • Research Site

    Houma, Louisiana, 70363, United States

  • Research Site

    Marrero, Louisiana, 70006, United States

  • Research Site

    Marrero, Louisiana, 70072, United States

  • Research Site

    Shreveport, Louisiana, 71105, United States

  • Research Site

    Ann Arbor, Michigan, 48109, United States

  • Research Site

    Las Vegas, Nevada, 89104, United States

  • Research Site

    Las Vegas, Nevada, 89109, United States

  • Research Site

    Lawrence, New Jersey, 08648, United States

  • Research Site

    Warren Township, New Jersey, 07059, United States

  • Research Site

    Morehead City, North Carolina, 28557, United States

  • Research Site

    Chattanooga, Tennessee, 37421, United States

  • Research Site

    Arlington, Texas, 76012, United States

  • Research Site

    Austin, Texas, 78745, United States

  • Research Site

    Dallas, Texas, 75230, United States

  • Research Site

    Lewisville, Texas, 75057, United States

  • Research Site

    San Antonio, Texas, 78215, United States

  • Research Site

    Ogden, Utah, 84403, United States

  • Research Site

    CABA, C1056ABJ, Argentina

  • Research Site

    Heidelberg, 3084, Australia

  • Research Site

    Kogarah, 2217, Australia

  • Research Site

    Meadowbrook, 4131, Australia

  • Research Site

    Melbourne, 3004, Australia

  • Research Site

    Westmead, 2145, Australia

  • Research Site

    Vienna, 1030, Austria

  • Research Site

    Vienna, 1130, Austria

  • Research Site

    London, Ontario, N6A 5A5, Canada

  • Research Site

    Terrebonne, Quebec, J6X 4P7, Canada

  • Research Site

    Montpellier, 34090, France

  • Research Site

    Paris, 75651, France

  • Research Site

    Dresden, 01307, Germany

  • Research Site

    Konstanz, 78464, Germany

  • Research Site

    Athens, 12462, Greece

  • Research Site

    Ioannina, 45500, Greece

  • Research Site

    Haifa, 34362, Israel

  • Research Site

    Jerusalem, 91031, Israel

  • Research Site

    Nahariya, 22100, Israel

  • Research Site

    Petah Tikva, 49100, Israel

  • Research Site

    Tel Aviv, 64239, Israel

  • Research Site

    Tel Litwinsky, 52621, Israel

  • Research Site

    Catania, 95100, Italy

  • Research Site

    Foggia, 71100, Italy

  • Research Site

    Milan, 20127, Italy

  • Research Site

    Roma, 00100, Italy

  • Research Site

    Roma, 00161, Italy

  • Research Site

    Rozzano, 20089, Italy

  • Research Site

    San Giovanni Rotondo, 71013, Italy

  • Research Site

    Chiba, 260-8677, Japan

  • Research Site

    Fukui-shi, 918-8503, Japan

  • Research Site

    Gifu, 500-8513, Japan

  • Research Site

    Hiroshima, 734-8551, Japan

  • Research Site

    Kawasaki-shi, 215-0026, Japan

  • Research Site

    Kawasaki-shi, 216-8511, Japan

  • Research Site

    Kure-shi, 737-0023, Japan

  • Research Site

    Osaka, 637086, Japan

  • Research Site

    Saga, 849-8501, Japan

  • Research Site

    Sapporo, 062-0921, Japan

  • Research Site

    Sendai, 980-0873, Japan

  • Research Site

    Shinjuku-ku, 160-0023, Japan

  • Research Site

    Suita-shi, 564-0013, Japan

  • Research Site

    Takasaki-shi, 370-0829, Japan

  • Research Site

    Toon-shi, 791-0281, Japan

  • Research Site

    Yokohama, 236-0004, Japan

  • Research Site

    Yokohama, 245-8575, Japan

  • Research Site

    Kuala Lumpur, 56000, Malaysia

  • Research Site

    Kuala Lumpur, 59100, Malaysia

  • Research Site

    Malacca, 75400, Malaysia

  • Research Site

    Seremban, 70300, Malaysia

  • Research Site

    Auckland, 2025, New Zealand

  • Research Site

    Christchurch, 8011, New Zealand

  • Research Site

    Grafton, 1023, New Zealand

  • Research Site

    Plumstead, 7800, South Africa

  • Research Site

    Busan, 49241, South Korea

  • Research Site

    Gangwon-do, 26426, South Korea

  • Research Site

    Junggu, 41944, South Korea

  • Research Site

    Seoul, 03080, South Korea

  • Research Site

    Seoul, 04763, South Korea

  • Research Site

    Seoul, 06351, South Korea

  • Research Site

    A Coruña, 15006, Spain

  • Research Site

    Almería, 04009, Spain

  • Research Site

    Lleida, 25198, Spain

  • Research Site

    Madrid, 28046, Spain

  • Research Site

    Málaga, 29010, Spain

  • Research Site

    Seville, 41013, Spain

  • Research Site

    Kaohsiung City, 80756, Taiwan

  • Research Site

    Tainan, 70403, Taiwan

  • Research Site

    Taipei, 110, Taiwan

  • Research Site

    Taipei, 11217, Taiwan

  • Research Site

    Taipei, 114, Taiwan

  • Research Site

    Bangkok, 10330, Thailand

  • Research Site

    Bangkok, 10400, Thailand

  • Research Site

    Bangkok, 10700, Thailand

  • Research Site

    Hat Yai, 90110, Thailand

  • Research Site

    Khon Kaen, 40002, Thailand

  • Research Site

    Ankara, 06800, Turkey (Türkiye)

  • Research Site

    Istanbul, 34093, Turkey (Türkiye)

  • Research Site

    Aberdeen, AB25 2ZN, United Kingdom

  • Research Site

    Glasgow, G51 4LB, United Kingdom

  • Research Site

    Ipswich, IP4 5PD, United Kingdom

  • Research Site

    Liverpool, L1 9ED, United Kingdom

  • Research Site

    London, EN1 1LJ, United Kingdom

  • Research Site

    Preston, PR2 9QB, United Kingdom

  • Research Site

    Rochdale, OL11 4AU, United Kingdom

  • Research Site

    Sheffield, S2 5FX, United Kingdom