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
Public ClinicalTrials.gov record NCT04048135. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of BIO89-100 Administered Subcutaneously in Subjects With Nonalcoholic Steatohepatitis (NASH) or With Nonalcoholic Fatty Liver Disease (NAFLD) and at High Risk of NASH
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Part 1: This is a multi-center evaluation of pegozafermin (administered weekly or every other week) in a randomized, double-blind, placebo-controlled study administered for 12 weeks in participants with NASH and NAFLD at high risk of NASH, including a pre-defined number of participants with biopsy confirmed NASH and fibrosis stages F1-F3 to be enrolled. 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).
Study identification
- NCT ID
- NCT04048135
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 101 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 21 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 29, 2019 (Actual)
- Primary completion
- Aug 28, 2020 (Actual)
- Completion
- Jan 19, 2022 (Actual)
- Last update posted
- Apr 2, 2024
2019 – 2022
United States locations
- U.S. sites
- 25
- U.S. states
- 11
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 89bio Clinical Study Site | Madison | Alabama | 35758 | — |
| 89bio Clinical Study Site | Chandler | Arizona | 85224 | — |
| 89bio Clinical Study Site | Tucson | Arizona | 85712 | — |
| 89bio Clinical Study Site | Chula Vista | California | 91911 | — |
| 89bio Clinical Study Site | Huntington Beach | California | 92647 | — |
| 89bio Clinical Study Site | Montclair | California | 91763 | — |
| 89bio Clinical Study Site | Miami | Florida | 33014-3616 | — |
| 89bio Clinical Study Site | Miami Lakes | Florida | 33014 | — |
| 89bio Clinical Study Site | Ocala | Florida | 34471 | — |
| 89bio Clinical Study Site | Sarasota | Florida | 34240 | — |
| 89bio Clinical Study Site | Lake Charles | Louisiana | 70601 | — |
| 89bio Clinical Study Site | Berlin | New Jersey | 08009 | — |
| 89bio Clinical Study Site | Florham Park | New Jersey | 07932 | — |
| 89bio Clinical Study Site | East Syracuse | New York | 13057 | — |
| 89bio Clinical Study Site | Concord | North Carolina | 28027 | — |
| 89bio Clinical Study Site | Raleigh | North Carolina | 27612 | — |
| 89bio Clinical Study Site | Greenwood | South Carolina | 29646 | — |
| 89bio Clinical Study Site | Summerville | South Carolina | 29485 | — |
| 89bio Clinical Study Site | Hermitage | Tennessee | 37076 | — |
| 89bio Clinical Study Site | Austin | Texas | 78757 | — |
| 89bio Clinical Study Site | Edinburg | Texas | 78539 | — |
| 89bio Clinical Study Site | Houston | Texas | 77058 | — |
| 89bio Clinical Study Site | San Antonio | Texas | 78215 | — |
| 89bio Clinical Study Site | San Antonio | Texas | 78229 | — |
| 89bio Clinical Study Site | Wichita Falls | Texas | 76301 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04048135, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 2, 2024 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04048135 live on ClinicalTrials.gov.