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New shot shows promise against fatty liver disease

NCT ID NCT05989711

Disease control Sponsor: Altimmune, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a weekly injection called pemvidutide in 212 adults with NASH, a serious liver condition linked to fat buildup. The goal was to see if the drug could reduce liver fat and scarring without worsening the disease. Participants received either the drug or a placebo for 24 weeks, and researchers measured changes in liver health through biopsies and scans.

What this could mean

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

Active substance
Pemvidutide (a weekly injection)
What this could lead to
If successful, this could provide a new treatment to reduce liver fat and scarring in people with NASH, potentially preventing progression to cirrhosis.
What could go wrong
This is an early Phase 2 trial with only 212 participants. The drug may not work better than placebo, and side effects are possible. Results need confirmation in larger studies.

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

212 people

The number who actually took part.

Started

Jul 2023

Finished

Nov 2025

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. Written informed consent 2. Male or female 18-75 years 3. Histologic diagnosis of NASH and/or histologic confirmation of NASH based on central pathology evaluation of a liver biopsy during screening 1. A histologic NAFLD Activity Score (NAS) ≥ 4 with a score of at least 1 on each subcomponent score based on central pathology evaluation (steatosis \[0-3\], lobular inflammation \[0-3\], and hepatocyte ballooning \[0-2\]) 2. NASH fibrosis stages 2 through 3 according to the NASH CRN fibrosis staging system based on central pathology evaluation 4. Subject agrees to have a liver biopsy performed during the screening period (if no biopsy within the preceding 6 months is available) and at 24 weeks of treatment 5. BMI ≥ 27.0 kg/m2 6. Subjects with Type 2 diabetes mellitus (T2D) should be on a stable treatment regimen for their T2D for at least 90 days prior to screening 7. Subject meets at least 3 of the 5 criteria of Metabolic Syndrome (American Heart Association 2005) 8. Liver fat content by MRI-PDFF ≥ 8% Exclusion Criteria: 1. Weight gain or loss \> 5% in the 3 months prior to randomization or \> 10% in the 6 months prior to screening 2. History or clinical evidence of Type 1 diabetes mellitus 3. Hemoglobin A1c (HbA1c) \> 9.5% or clinically significant persistent hyperglycemia 4. Liver conditions: 1. History of cirrhosis or complications of cirrhosis, including but not limited to variceal bleeding, encephalopathy, or ascites 2. Documented causes of chronic liver disease other than NASH 3. ALT or AST laboratory values \> 5 × ULN

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Conditions

The condition(s) this trial relates to.

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-alcoholic steatohepatitis (NASH)

Contacts and locations

Locations

  • Altimmune Clinial Study Site

    Tucson, Arizona, 85704, United States

  • Altimmune Clinical Study Site

    Chandler, Arizona, 85224, United States

  • Altimmune Clinical Study Site

    Peoria, Arizona, 85345, United States

  • Altimmune Clinical Study Site

    Tucson, Arizona, 85701, United States

  • Altimmune Clinical Study Site

    North Hollywood, California, 33019, United States

  • Altimmune Clinical Study Site

    Panorama City, California, 91402, United States

  • Altimmune Clinical Study Site

    Englewood, Colorado, 80110, United States

  • Altimmune Clinical Study Site

    Bradenton, Florida, 34201, United States

  • Altimmune Clinical Study Site

    Fort Myers, Florida, 33912, United States

  • Altimmune Clinical Study Site

    Hialeah Gardens, Florida, 33018, United States

  • Altimmune Clinical Study Site

    Miami Lakes, Florida, 33014, United States

  • Altimmune Clinical Study Site

    Port Orange, Florida, 32123, United States

  • Altimmune Clinical Study Site

    Sarasota, Florida, 34240, United States

  • Altimmune Clinical Study Site

    West Palm Beach, Florida, 33401, United States

  • Altimmune Clinical Study Site

    Dalton, Georgia, 30720, United States

  • Altimmune Clinical Study Site

    Marietta, Georgia, 30006, United States

  • Altimmune Clinical Study Site

    Bastrop, Louisiana, 78602, United States

  • Altimmune Clinical Study Site

    Shreveport, Louisiana, 71101, United States

  • Altimmune Clinical Study Site

    Clarksville, Tennessee, 37040, United States

  • Altimmune Clinical Study Site

    Germantown, Tennessee, 38138, United States

  • Altimmune Clinical Study Site

    Austin, Texas, 73301, United States

  • Altimmune Clinical Study Site

    Bellaire, Texas, 77401, United States

  • Altimmune Clinical Study Site

    Edinburg, Texas, 78539, United States

  • Altimmune Clinical Study Site

    Edinburg, Texas, 78540, United States

  • Altimmune Clinical Study Site

    Georgetown, Texas, 78626, United States

  • Altimmune Clinical Study Site

    Houston, Texas, 77036, United States

  • Altimmune Clinical Study Site

    San Antonio, Texas, 78201, United States

  • Altimmune Clinical Study Site

    San Antonio, Texas, 78204, United States

  • Altimmune Clinical Study Site

    West Jordan, Utah, 84081, United States

  • Altimmune Clinical Study Site

    San Juan, 00901, Puerto Rico

  • Austin Health

    Heidelberg, Victoria, 3084, Australia

  • Box Hill Hospital

    Box Hill, Victory, 3128, Australia

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150, Australia

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042, Australia

  • Liverpool Hospital

    Liverpool, New South Wales, 2170, Australia

  • Monash Hospital

    Clayton, Victory, 3168, Australia

  • Princess Alexandra Hospital/ Translational Research Institute

    Woolloongabba, Queensland, 4102, Australia

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050, Australia

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009, Australia

  • St. Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065, Australia

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