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NCT04929483CompletedPhase 2

Study Evaluating the Safety, Efficacy and Tolerability of BIO89-100 in Subjects With Biopsy-confirmed Nonalcoholic Steatohepatitis (NASH)

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of BIO89-100 in Subjects With Biopsy-Confirmed Nonalcoholic Steatohepatitis (NASH)

Source: ClinicalTrials.gov · Last updated 6 Jan 2026

Brief summary (registry, in English)

This is a randomized, double-blind, placebo-controlled study that will evaluate the safety, efficacy, tolerability of BIO89-100 in patients with biopsy-confirmed fibrosis stages F2-F3 NASH.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
222 (actual)
First submitted
10 Jun 2021
Start date
4 Jun 2021
Primary completion date
14 Feb 2023
Lead sponsor
89bio, Inc.
NCT number
NCT04929483

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 222
  • From 4 Jun 2021 to the primary completion date, 14 Feb 2023
  • 72 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Have type 1 diabetes or poorly controlled type 2 diabetes.
  • History of cirrhosis or evidence of cirrhosis by clinical, imaging, or liver biopsy evaluation

Other

  • Have poorly controlled high blood pressure
  • 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.

Who the study is looking for

  • 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

Age in the registry: 21 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (72)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
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San JuanPuerto RicoUnknown status
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AthensUnited StatesUnknown status
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AustinUnited StatesUnknown status
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BeaumontUnited StatesUnknown status
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BirminghamUnited StatesUnknown status
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Boynton BeachUnited StatesUnknown status
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BradentonUnited StatesUnknown status
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ChandlerUnited StatesUnknown status
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ChattanoogaUnited StatesUnknown status
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Chula VistaUnited StatesUnknown status
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ColumbusUnited StatesUnknown status
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ConcordUnited StatesUnknown status
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DallasUnited StatesUnknown status
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DaytonUnited StatesUnknown status
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DothanUnited StatesUnknown status
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EdinburgUnited StatesUnknown status
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EnglewoodUnited StatesUnknown status
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Florham ParkUnited StatesUnknown status
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Fort MyersUnited StatesUnknown status
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Fort WorthUnited StatesUnknown status
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GarlandUnited StatesUnknown status
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Glen BurnieUnited StatesUnknown status
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GlendaleUnited StatesUnknown status
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GreenbeltUnited StatesUnknown status
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GreenwoodUnited StatesUnknown status
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GuntersvilleUnited StatesUnknown status
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HermitageUnited StatesUnknown status
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HoustonUnited StatesUnknown status
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Huntington ParkUnited StatesUnknown status
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Iowa CityUnited StatesUnknown status
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LakelandUnited StatesUnknown status
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Las VegasUnited StatesUnknown status
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Little RockUnited StatesUnknown status
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Long BeachUnited StatesUnknown status
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MadisonUnited StatesUnknown status
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MaitlandUnited StatesUnknown status
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ManassasUnited StatesUnknown status
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MarreroUnited StatesUnknown status
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MiamiUnited StatesUnknown status
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Miami LakesUnited StatesUnknown status
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MonroeUnited StatesUnknown status
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New AlbanyUnited StatesUnknown status
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New YorkUnited StatesUnknown status
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OcalaUnited StatesUnknown status
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OgdenUnited StatesUnknown status
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OrangeUnited StatesUnknown status
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Palmetto BayUnited StatesUnknown status
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Panorama CityUnited StatesUnknown status
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PeoriaUnited StatesUnknown status
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Pinellas ParkUnited StatesUnknown status
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Port OrangeUnited StatesUnknown status
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RialtoUnited StatesUnknown status
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RichmondUnited StatesUnknown status
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RoanokeUnited StatesUnknown status
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San AntonioUnited StatesUnknown status
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Sandy CityUnited StatesUnknown status
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Sandy SpringsUnited StatesUnknown status
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Santa AnaUnited StatesUnknown status
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SarasotaUnited StatesUnknown status
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SeattleUnited StatesUnknown status
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ShreveportUnited StatesUnknown status
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South BendUnited StatesUnknown status
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SpokaneUnited StatesUnknown status
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SpringboroUnited StatesUnknown status
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St LouisUnited StatesUnknown status
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SummervilleUnited StatesUnknown status
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TopekaUnited StatesUnknown status
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TucsonUnited StatesUnknown status
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VieraUnited StatesUnknown status
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WacoUnited StatesUnknown status
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WestlakeUnited StatesUnknown status
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Wichita FallsUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.