Study Evaluating the Safety, Efficacy and Tolerability of BIO89-100 in Subjects With Biopsy-confirmed Nonalcoholic Steatohepatitis (NASH)
NCT ID: NCT04929483
Last Updated: 2026-01-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
222 participants
INTERVENTIONAL
2021-06-04
2024-10-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BIO89-100 - 15 mg once weekly (QW)
BIO89-100
Subcutaneous injection
BIO89-100 - 30 mg QW
BIO89-100
Subcutaneous injection
BIO89-100 - 44 mg once every 2 weeks (Q2W)
BIO89-100
Subcutaneous injection
Placebo QW
Placebo
Subcutaneous injection
Placebo Q2W
Placebo
Subcutaneous injection
Placebo QW (Main study)/ BIO89-100 - 30 mg QW (Extension)
BIO89-100
Subcutaneous injection
Placebo
Subcutaneous injection
Interventions
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BIO89-100
Subcutaneous injection
Placebo
Subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
21 Years
75 Years
ALL
No
Sponsors
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89bio, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Millie Gottwald, PharmD
Role: STUDY_DIRECTOR
89bio, Inc.
Locations
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89bio Clinical Study Site
Birmingham, Alabama, United States
89bio Clinical Study Site
Birmingham, Alabama, United States
89bio Clinical Study Site
Dothan, Alabama, United States
89bio Clinical Study Site
Guntersville, Alabama, United States
89bio Clinical Study Site
Madison, Alabama, United States
89bio Clinical Study Site
Chandler, Arizona, United States
89bio Clinical Study Site
Glendale, Arizona, United States
89bio Clinical Study Site
Peoria, Arizona, United States
89bio Clinical Study Site
Tucson, Arizona, United States
89bio Clinical Study Site
Tucson, Arizona, United States
89bio Clinical Study Site
Tucson, Arizona, United States
89bio Clinical Study Site
Little Rock, Arkansas, United States
89bio Clinical Study Site
Little Rock, Arkansas, United States
89bio Clinical Study Site
Chula Vista, California, United States
89bio Clinical Study Site
Huntington Park, California, United States
89bio Clinical Study Site
Long Beach, California, United States
89bio Clinical Study Site
Orange, California, United States
89bio Clinical Study Site
Panorama City, California, United States
89bio Clinical Study Site
Rialto, California, United States
89bio Clinical Study Site
Santa Ana, California, United States
89bio Clinical Study Site
Englewood, Colorado, United States
89bio Clinical Study Site
Boynton Beach, Florida, United States
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Bradenton, Florida, United States
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Fort Myers, Florida, United States
89bio Clinical Study Site
Lakeland, Florida, United States
89bio Clinical Study Site
Maitland, Florida, United States
89bio Clinical Study Site
Miami, Florida, United States
89bio Clinical Study Site
Miami, Florida, United States
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Miami, Florida, United States
89bio Clinical Study Site
Miami Lakes, Florida, United States
89bio Clinical Study Site
Ocala, Florida, United States
89bio Clinical Study Site
Palmetto Bay, Florida, United States
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Pinellas Park, Florida, United States
89bio Clinical Study Site
Port Orange, Florida, United States
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Sarasota, Florida, United States
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Viera, Florida, United States
89bio Clinical Study Site
Athens, Georgia, United States
89bio Clinical Study Site
Sandy Springs, Georgia, United States
89bio Clinical Study Site
New Albany, Indiana, United States
89bio Clinical Study Site
South Bend, Indiana, United States
89bio Clinical Study Site
Iowa City, Iowa, United States
89bio Clinical Study Site
Topeka, Kansas, United States
89bio Clinical Study Site
Marrero, Louisiana, United States
89bio Clinical Study Site
Marrero, Louisiana, United States
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Monroe, Louisiana, United States
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Shreveport, Louisiana, United States
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Glen Burnie, Maryland, United States
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Greenbelt, Maryland, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Florham Park, New Jersey, United States
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New York, New York, United States
89bio Clinical Study Site
Concord, North Carolina, United States
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Columbus, Ohio, United States
89bio Clinical Study Site
Dayton, Ohio, United States
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Springboro, Ohio, United States
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Westlake, Ohio, United States
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Greenwood, South Carolina, United States
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Summerville, South Carolina, United States
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Chattanooga, Tennessee, United States
89bio Clinical Study Site
Chattanooga, Tennessee, United States
89bio Clinical Study Site
Hermitage, Tennessee, United States
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Austin, Texas, United States
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Austin, Texas, United States
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Beaumont, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Edinburg, Texas, United States
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Fort Worth, Texas, United States
89bio Clinical Study Site
Garland, Texas, United States
89bio Clinical Study Site
Houston, Texas, United States
89bio Clinical Study Site
Houston, Texas, United States
89bio Clinical Study Site
San Antonio, Texas, United States
89bio Clinical Study Site
San Antonio, Texas, United States
89bio Clinical Study Site
San Antonio, Texas, United States
89bio Clinical Study Site
San Antonio, Texas, United States
89bio Clinical Study Site
Waco, Texas, United States
89bio Clinical Study Site
Waco, Texas, United States
89bio Clinical Study Site
Wichita Falls, Texas, United States
89bio Clinical Study Site
Ogden, Utah, United States
89bio Clinical Study Site
Sandy City, Utah, United States
89bio Clinical Study Site
Manassas, Virginia, United States
89bio Clinical Study Site
Richmond, Virginia, United States
89bio Clinical Study Site
Richmond, Virginia, United States
89bio Clinical Study Site
Roanoke, Virginia, United States
89bio Clinical Study Site
Seattle, Washington, United States
89bio Clinical Study Site
Spokane, Washington, United States
89bio Clinical Study Site
San Juan, , Puerto Rico
Countries
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References
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Tseng CL, Balic K, Charlton RW, Margalit M, Mansbach H, Savic RM. Population Pharmacokinetics and Pharmacodynamics of Pegozafermin in Patients with Nonalcoholic Steatohepatitis. Clin Pharmacol Ther. 2023 Dec;114(6):1323-1331. doi: 10.1002/cpt.3046. Epub 2023 Oct 2.
Loomba R, Sanyal AJ, Kowdley KV, Bhatt DL, Alkhouri N, Frias JP, Bedossa P, Harrison SA, Lazas D, Barish R, Gottwald MD, Feng S, Agollah GD, Hartsfield CL, Mansbach H, Margalit M, Abdelmalek MF. Randomized, Controlled Trial of the FGF21 Analogue Pegozafermin in NASH. N Engl J Med. 2023 Sep 14;389(11):998-1008. doi: 10.1056/NEJMoa2304286. Epub 2023 Jun 24.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BIO89-100-122
Identifier Type: -
Identifier Source: org_study_id
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