New drug shows promise for reversing liver damage in NASH patients

NCT ID NCT04929483

Disease control Sponsor: 89bio, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new drug called BIO89-100 (Pegozafermin) in 222 adults with NASH, a serious fatty liver disease with liver scarring. Participants received weekly injections of the drug or a placebo for about 6 months. The goal was to see if the drug could reduce liver inflammation and fat without worsening scarring. Results showed some improvement in liver health, but more research is needed.

What this could mean

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

Active substance: BIO89-100 (Pegozafermin)
What this could lead to: If successful, this could lead to a treatment that reverses liver inflammation and scarring in people with NASH, potentially preventing progression to cirrhosis.
What could go wrong: This is a Phase 2 trial with 222 participants, so results are still early. The drug may not work in larger, longer studies, and side effects are still being evaluated.

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

222 people

The number who actually took part.

Started

Jun 2021

Finished

Oct 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

21 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: * Age 21 to 75 * Biopsy-confirmed NASH with fibrosis stage F2 or F3 per NASH CRN System and NAS ≥4, with a score of at least 1 in each of steatosis, ballooning degeneration, and lobular inflammation. * Qualifying biopsy must be either within 6 months of screening visit or obtained during screening period Key Exclusion Criteria: * Have poorly controlled high blood pressure * Have type 1 diabetes or poorly controlled type 2 diabetes. * History of cirrhosis or evidence of cirrhosis by clinical, imaging, or liver biopsy evaluation * Are planning to try to lose weight during the conduct of the study. * Have a BMI \<25 kg/m2 Other inclusion and exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

Digestive System Diseases fatty liver disease liver disorder metabolic disease 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.

NASH - nonalcoholic steatohepatitis

Contacts and locations

Locations

89bio Clinical Study Site

Birmingham, Alabama, 35209, United States
89bio Clinical Study Site

Birmingham, Alabama, 35211, United States
89bio Clinical Study Site

Dothan, Alabama, 36305, United States
89bio Clinical Study Site

Guntersville, Alabama, 35976, United States
89bio Clinical Study Site

Madison, Alabama, 35758, United States
89bio Clinical Study Site

Chandler, Arizona, 85224, United States
89bio Clinical Study Site

Glendale, Arizona, 85036, United States
89bio Clinical Study Site

Peoria, Arizona, 85306, United States
89bio Clinical Study Site

Tucson, Arizona, 85712-4044, United States
89bio Clinical Study Site

Tucson, Arizona, 85712-4046, United States
89bio Clinical Study Site

Tucson, Arizona, 85741, United States
89bio Clinical Study Site

Little Rock, Arkansas, 72205-6414, United States
89bio Clinical Study Site

Little Rock, Arkansas, 72205, United States
89bio Clinical Study Site

Chula Vista, California, 91911, United States
89bio Clinical Study Site

Huntington Park, California, 90255, United States
89bio Clinical Study Site

Long Beach, California, 90808, United States
89bio Clinical Study Site

Orange, California, 92866, United States
89bio Clinical Study Site

Panorama City, California, 91402, United States
89bio Clinical Study Site

Rialto, California, 92377, United States
89bio Clinical Study Site

Santa Ana, California, 92704, United States
89bio Clinical Study Site

Englewood, Colorado, 80113, United States
89bio Clinical Study Site

Boynton Beach, Florida, 33472, United States
89bio Clinical Study Site

Bradenton, Florida, 34208, United States
89bio Clinical Study Site

Fort Myers, Florida, 33912, United States
89bio Clinical Study Site

Lakeland, Florida, 33805, United States
89bio Clinical Study Site

Maitland, Florida, 32127, United States
89bio Clinical Study Site

Miami, Florida, 33014, United States
89bio Clinical Study Site

Miami, Florida, 33147, United States
89bio Clinical Study Site

Miami, Florida, 33157, United States
89bio Clinical Study Site

Miami Lakes, Florida, 33016, United States
89bio Clinical Study Site

Ocala, Florida, 34471, United States
89bio Clinical Study Site

Palmetto Bay, Florida, 33157, United States
89bio Clinical Study Site

Pinellas Park, Florida, 33781, United States
89bio Clinical Study Site

Port Orange, Florida, 32127, United States
89bio Clinical Study Site

Sarasota, Florida, 34240, United States
89bio Clinical Study Site

Viera, Florida, 32940, United States
89bio Clinical Study Site

Athens, Georgia, 30607, United States
89bio Clinical Study Site

Sandy Springs, Georgia, 30328, United States
89bio Clinical Study Site

New Albany, Indiana, 47150, United States
89bio Clinical Study Site

South Bend, Indiana, 46635, United States
89bio Clinical Study Site

Iowa City, Iowa, 52246, United States
89bio Clinical Study Site

Topeka, Kansas, 66606, United States
89bio Clinical Study Site

Marrero, Louisiana, 70072-3151, United States
89bio Clinical Study Site

Marrero, Louisiana, 70072-3155, United States
89bio Clinical Study Site

Monroe, Louisiana, 71201, United States
89bio Clinical Study Site

Shreveport, Louisiana, 71103, United States
89bio Clinical Study Site

Glen Burnie, Maryland, 21061, United States
89bio Clinical Study Site

Greenbelt, Maryland, 20770, United States
89bio Clinical Study Site

St Louis, Missouri, 63033, United States
89bio Clinical Study Site

Las Vegas, Nevada, 89119, United States
89bio Clinical Study Site

Las Vegas, Nevada, 89121, United States
89bio Clinical Study Site

Florham Park, New Jersey, 07932, United States
89bio Clinical Study Site

New York, New York, 10033, United States
89bio Clinical Study Site

Concord, North Carolina, 28027, United States
89bio Clinical Study Site

Columbus, Ohio, 43210, United States
89bio Clinical Study Site

Dayton, Ohio, 45414, United States
89bio Clinical Study Site

Springboro, Ohio, 45066, United States
89bio Clinical Study Site

Westlake, Ohio, 44145, United States
89bio Clinical Study Site

Greenwood, South Carolina, 29646, United States
89bio Clinical Study Site

Summerville, South Carolina, 29485, United States
89bio Clinical Study Site

Chattanooga, Tennessee, 37411, United States
89bio Clinical Study Site

Chattanooga, Tennessee, 37421, United States
89bio Clinical Study Site

Hermitage, Tennessee, 37076, United States
89bio Clinical Study Site

Austin, Texas, 78757-8051, United States
89bio Clinical Study Site

Austin, Texas, 78757-8059, United States
89bio Clinical Study Site

Beaumont, Texas, 77702, United States
89bio Clinical Study Site

Dallas, Texas, 75234, United States
89bio Clinical Study Site

Dallas, Texas, 75246, United States
89bio Clinical Study Site

Edinburg, Texas, 78539, United States
89bio Clinical Study Site

Fort Worth, Texas, 76104, United States
89bio Clinical Study Site

Garland, Texas, 75044, United States
89bio Clinical Study Site

Houston, Texas, 77030, United States
89bio Clinical Study Site

Houston, Texas, 77099, United States
89bio Clinical Study Site

San Antonio, Texas, 78209, United States
89bio Clinical Study Site

San Antonio, Texas, 78215, United States
89bio Clinical Study Site

San Antonio, Texas, 78229-4801, United States
89bio Clinical Study Site

San Antonio, Texas, 78229-5069, United States
89bio Clinical Study Site

Waco, Texas, 76710, United States
89bio Clinical Study Site

Waco, Texas, 76712, United States
89bio Clinical Study Site

Wichita Falls, Texas, 76301, United States
89bio Clinical Study Site

Ogden, Utah, 84405, United States
89bio Clinical Study Site

Sandy City, Utah, 84092, United States
89bio Clinical Study Site

Manassas, Virginia, 20110, United States
89bio Clinical Study Site

Richmond, Virginia, 23235, United States
89bio Clinical Study Site

Richmond, Virginia, 23249, United States
89bio Clinical Study Site

Roanoke, Virginia, 24014, United States
89bio Clinical Study Site

Seattle, Washington, 98105, United States
89bio Clinical Study Site

Spokane, Washington, 99202, United States
89bio Clinical Study Site

San Juan, 00927, Puerto Rico

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