A Multiple Ascending Dose Study of Pegozafermin in Participants With Biopsy Confirmed Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) and at High Risk of NASH
NCT ID: NCT04048135
Last Updated: 2024-04-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
101 participants
INTERVENTIONAL
2019-07-29
2022-01-19
Brief Summary
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Part 2: This is a multi-center, open label evaluation of pegozafermin at 27 mg administered weekly for 20 weeks in participants with biopsy-proven NASH (NAS ≥4, fibrosis stage F2 or F3).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Part 1: Pegozafermin 3 milligrams (mg) weekly (QW)
Participants were administered 3 mg of pegozafermin QW, via subcutaneous (SC) injection, starting on Day 1 through Day 85.
Pegozafermin
Subcutaneous injection
Part 1: Pegozafermin 9 mg QW
Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.
Pegozafermin
Subcutaneous injection
Part 1: Pegozafermin 18 mg QW
Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.
Pegozafermin
Subcutaneous injection
Part 1: Pegozafermin 27 mg QW
Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.
Pegozafermin
Subcutaneous injection
Part 1: Pegozafermin 18 mg Every 2 Weeks (Q2W)
Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.
Pegozafermin
Subcutaneous injection
Part 1: Pegozafermin 36 mg Q2W
Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.
Pegozafermin
Subcutaneous injection
Part 1: Placebo QW or Q2W
Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85.
Placebo
Subcutaneous injection
Part 2: Pegozafermin 27 mg QW
Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 134.
Pegozafermin
Subcutaneous injection
Interventions
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Pegozafermin
Subcutaneous injection
Placebo
Subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Evidence of steatosis by Fibroscan and magnetic resonance imaging based proton density fat fraction (MRI-PDFF)
* NASH or NAFLD at high risk for NASH as reflected by AT LEAST ONE of the following:
* Diagnosis of NASH with fibrosis (stages F1, F2 or F3), without cirrhosis, by percutaneous liver biopsy within 24 months prior to screening
* Central obesity WITH type 2 diabetes mellitus (T2DM)
* Central obesity WITH either increased alanine transaminase (ALT) and/or Fibroscan vibration-controlled transient elastography (VCTE) score ≥7 KPa.
* Part 2 only: Biopsy-proven NASH in a liver biopsy obtained within 24 weeks of baseline with fibrosis stage F2 or F3 and NAS ≥4, with a score of at least 1 in each of steatosis, ballooning degeneration, and lobular inflammation. A small number of high risk F1 allowed.
Exclusion Criteria
* History of type 1 diabetes.
* Weight loss of more than 5% within 3 months prior to Day -1 or more than 10% within 6 months prior to Day -1 or planning to try to lose weight during conduct of study.
* History of a liver disorder other than NASH or clinical suspicion of a liver disorder other than NASH
* History of cirrhosis or evidence of cirrhosis
21 Years
75 Years
ALL
No
Sponsors
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ProSciento, Inc.
INDUSTRY
89bio, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Charlton, MD
Role: STUDY_DIRECTOR
89bio, Inc.
Locations
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89bio Clinical Study Site
Madison, Alabama, United States
89bio Clinical Study Site
Chandler, Arizona, United States
89bio Clinical Study Site
Tucson, Arizona, United States
89bio Clinical Study Site
Chula Vista, California, United States
89bio Clinical Study Site
Huntington Beach, California, United States
89bio Clinical Study Site
Montclair, California, United States
89bio Clinical Study Site
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
Sarasota, Florida, United States
89bio Clinical Study Site
Lake Charles, Louisiana, United States
89bio Clinical Study Site
Berlin, New Jersey, United States
89bio Clinical Study Site
Florham Park, New Jersey, United States
89bio Clinical Study Site
East Syracuse, New York, United States
89bio Clinical Study Site
Concord, North Carolina, United States
89bio Clinical Study Site
Raleigh, North Carolina, United States
89bio Clinical Study Site
Greenwood, South Carolina, United States
89bio Clinical Study Site
Summerville, South Carolina, United States
89bio Clinical Study Site
Hermitage, Tennessee, United States
89bio Clinical Study Site
Austin, Texas, United States
89bio Clinical Study Site
Edinburg, 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
Wichita Falls, Texas, United States
89bio Clinical Study Site
San Juan, , Puerto Rico
Countries
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References
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Alkhouri N, Lazas D, Loomba R, Frias JP, Feng S, Tseng L, Balic K, Agollah GD, Kwan T, Iyer JS, Morrow L, Mansbach H, Margalit M, Harrison SA. Clinical trial: Effects of pegozafermin on the liver and on metabolic comorbidities in subjects with biopsy-confirmed nonalcoholic steatohepatitis. Aliment Pharmacol Ther. 2023 Nov;58(10):1005-1015. doi: 10.1111/apt.17709. Epub 2023 Sep 18.
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, Lawitz EJ, Frias JP, Ortiz-Lasanta G, Johansson L, Franey BB, Morrow L, Rosenstock M, Hartsfield CL, Chen CY, Tseng L, Charlton RW, Mansbach H, Margalit M. Safety, pharmacokinetics, and pharmacodynamics of pegozafermin in patients with non-alcoholic steatohepatitis: a randomised, double-blind, placebo-controlled, phase 1b/2a multiple-ascending-dose study. Lancet Gastroenterol Hepatol. 2023 Feb;8(2):120-132. doi: 10.1016/S2468-1253(22)00347-8. Epub 2022 Dec 12.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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BIO89-100-002
Identifier Type: -
Identifier Source: org_study_id
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