NASH - Nonalcoholic SteatohepatitisPhase 2ENLIVENNCT04929483

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

A Phase 2 study testing BIO89-100 in people with NASH - Nonalcoholic Steatohepatitis, run by 89bio, Inc. at 89 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 21 to 75 years
Conditions the study is for: NASH - Nonalcoholic Steatohepatitis
What is being tested?: BIO89-100
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 222 participants
Where: 89 sitesin 2 countries
Study dates: 4 Jun 2021to 8 Oct 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

89 sites in 2 countries.

Country

City, postcode or hospital

89 sites in 2 countries

United States88 sites

89bio Clinical Study Site
Athens, Georgia, 30607
89bio Clinical Study Site
Austin, Texas, 78757-8051
89bio Clinical Study Site
Austin, Texas, 78757-8059
89bio Clinical Study Site
Beaumont, Texas, 77702
89bio Clinical Study Site
Birmingham, Alabama, 35209
89bio Clinical Study Site
Birmingham, Alabama, 35211
89bio Clinical Study Site
Boynton Beach, Florida, 33472
89bio Clinical Study Site
Bradenton, Florida, 34208
89bio Clinical Study Site
Chandler, Arizona, 85224
89bio Clinical Study Site
Chattanooga, Tennessee, 37411
89bio Clinical Study Site
Chattanooga, Tennessee, 37421
89bio Clinical Study Site
Chula Vista, California, 91911
89bio Clinical Study Site
Columbus, Ohio, 43210
89bio Clinical Study Site
Concord, North Carolina, 28027
89bio Clinical Study Site
Dallas, Texas, 75234
89bio Clinical Study Site
Dallas, Texas, 75246
89bio Clinical Study Site
Dayton, Ohio, 45414
89bio Clinical Study Site
Dothan, Alabama, 36305
89bio Clinical Study Site
Edinburg, Texas, 78539
89bio Clinical Study Site
Englewood, Colorado, 80113
89bio Clinical Study Site
Florham Park, New Jersey, 07932
89bio Clinical Study Site
Fort Myers, Florida, 33912
89bio Clinical Study Site
Fort Worth, Texas, 76104
89bio Clinical Study Site
Garland, Texas, 75044
89bio Clinical Study Site
Glen Burnie, Maryland, 21061
89bio Clinical Study Site
Glendale, Arizona, 85036
89bio Clinical Study Site
Greenbelt, Maryland, 20770
89bio Clinical Study Site
Greenwood, South Carolina, 29646
89bio Clinical Study Site
Guntersville, Alabama, 35976
89bio Clinical Study Site
Hermitage, Tennessee, 37076
89bio Clinical Study Site
Houston, Texas, 77030
89bio Clinical Study Site
Houston, Texas, 77099
89bio Clinical Study Site
Huntington Park, California, 90255
89bio Clinical Study Site
Iowa City, Iowa, 52246
89bio Clinical Study Site
Lakeland, Florida, 33805
89bio Clinical Study Site
Las Vegas, Nevada, 89119
89bio Clinical Study Site
Las Vegas, Nevada, 89121
89bio Clinical Study Site
Little Rock, Arkansas, 72205-6414
89bio Clinical Study Site
Little Rock, Arkansas, 72205
89bio Clinical Study Site
Long Beach, California, 90808
89bio Clinical Study Site
Madison, Alabama, 35758
89bio Clinical Study Site
Maitland, Florida, 32127
89bio Clinical Study Site
Manassas, Virginia, 20110
89bio Clinical Study Site
Marrero, Louisiana, 70072-3151
89bio Clinical Study Site
Marrero, Louisiana, 70072-3155
89bio Clinical Study Site
Miami, Florida, 33014
89bio Clinical Study Site
Miami, Florida, 33147
89bio Clinical Study Site
Miami, Florida, 33157
89bio Clinical Study Site
Miami Lakes, Florida, 33016
89bio Clinical Study Site
Monroe, Louisiana, 71201
89bio Clinical Study Site
New Albany, Indiana, 47150
89bio Clinical Study Site
New York, New York, 10033
89bio Clinical Study Site
Ocala, Florida, 34471
89bio Clinical Study Site
Ogden, Utah, 84405
89bio Clinical Study Site
Orange, California, 92866
89bio Clinical Study Site
Palmetto Bay, Florida, 33157
89bio Clinical Study Site
Panorama City, California, 91402
89bio Clinical Study Site
Peoria, Arizona, 85306
89bio Clinical Study Site
Pinellas Park, Florida, 33781
89bio Clinical Study Site
Port Orange, Florida, 32127
89bio Clinical Study Site
Rialto, California, 92377
89bio Clinical Study Site
Richmond, Virginia, 23235
89bio Clinical Study Site
Richmond, Virginia, 23249
89bio Clinical Study Site
Roanoke, Virginia, 24014
89bio Clinical Study Site
San Antonio, Texas, 78209
89bio Clinical Study Site
San Antonio, Texas, 78215
89bio Clinical Study Site
San Antonio, Texas, 78229-4801
89bio Clinical Study Site
San Antonio, Texas, 78229-5069
89bio Clinical Study Site
Sandy City, Utah, 84092
89bio Clinical Study Site
Sandy Springs, Georgia, 30328
89bio Clinical Study Site
Santa Ana, California, 92704
89bio Clinical Study Site
Sarasota, Florida, 34240
89bio Clinical Study Site
Seattle, Washington, 98105
89bio Clinical Study Site
Shreveport, Louisiana, 71103
89bio Clinical Study Site
South Bend, Indiana, 46635
89bio Clinical Study Site
Spokane, Washington, 99202
89bio Clinical Study Site
Springboro, Ohio, 45066
89bio Clinical Study Site
St Louis, Missouri, 63033
89bio Clinical Study Site
Summerville, South Carolina, 29485
89bio Clinical Study Site
Topeka, Kansas, 66606
89bio Clinical Study Site
Tucson, Arizona, 85712-4044
89bio Clinical Study Site
Tucson, Arizona, 85712-4046
89bio Clinical Study Site
Tucson, Arizona, 85741
89bio Clinical Study Site
Viera, Florida, 32940
89bio Clinical Study Site
Waco, Texas, 76710
89bio Clinical Study Site
Waco, Texas, 76712
89bio Clinical Study Site
Westlake, Ohio, 44145
89bio Clinical Study Site
Wichita Falls, Texas, 76301

Other trials in United States

Puerto Rico1 site

89bio Clinical Study Site
San Juan, 00927

Other trials in Puerto Rico

About this study

Official title: 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)

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.

Conditions: NASH - Nonalcoholic Steatohepatitis
Being tested: BIO89-100, Placebo
Keywords: Liver Diseases, Fatty Liver, Digestive System Diseases, Non-alcoholic Fatty Liver Disease, Metabolic diseases, MASH MAFLD, NASH NAFLD
Medical subject headings: Non-alcoholic Fatty Liver Disease, Liver Diseases, Fatty Liver, Digestive System Diseases, Metabolic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BIO89-100Drug
Also called Pegozafermin
Subcutaneous injection
PlaceboDrug
Subcutaneous injection

Study groups in NCT04929483
Study group	Role	What they receive
BIO89-100 - 15 mg once weekly (QW)	Experimental	Not described Receives: Drug: BIO89-100
BIO89-100 - 30 mg QW	Experimental	Not described Receives: Drug: BIO89-100
BIO89-100 - 44 mg once every 2 weeks (Q2W)	Experimental	Not described Receives: Drug: BIO89-100
Placebo QW	Placebo comparator	Not described Receives: Drug: Placebo
Placebo Q2W	Placebo comparator	Not described Receives: Drug: Placebo
Placebo QW (Main study)/ BIO89-100 - 30 mg QW (Extension)	Experimental	Not described Receives: Drug: BIO89-100; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Main Study: Number of Participants With Histological Resolution of Nonalcoholic Steatohepatitis (NASH) Without Worsening of Fibrosis
Nonalcoholic fatty liver disease activity score (NAS) was the sum of the scores of steatosis, inflammation, and ballooning. NAS score ranged from 0 to 8, with higher scores indicating worse disease severity. Resolution of NASH was defined as the total absence of ballooning (score=0) and absent or mild inflammation (score=0 to 1). NASH clinical research system (CRN) fibrosis is staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis). Worsening of fibrosis was defined as progression of fibrosis greater than or equal to (≥) 1 stage in NASH CRN fibrosis score.
Measured: Week 24
Main Study: Number of Participants Who Achieved Improvement of Fibrosis ≥1 Stage Without Worsening of NASH
Worsening of NASH was defined as increase in nonalcoholic fatty liver disease activity score (NAS) for ballooning, inflammation, or steatosis. NAS was the sum of the scores of steatosis, inflammation, and ballooning. NAS score ranged from 0 to 8, with higher scores indicating worse disease severity. Fibrosis improvement was defined as ≥1-stage decrease in NASH CRN fibrosis score. NASH CRN fibrosis was staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis).
Measured: Week 24

Secondary outcomes (18)

Main Study: Number of Participants With at Least a 2-Point Improvement in NAS and no Worsening of Fibrosis
NAS was the sum of the scores of steatosis, inflammation, and ballooning. NAS score ranged from 0 to 8, with higher scores indicating worse disease severity. Worsening of fibrosis was defined as progression of fibrosis ≥1 stage in NASH CRN fibrosis score. NASH CRN fibrosis is staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis).
Measured: Week 24
Main Study: Number of Participants With NASH Resolution and Fibrosis Improvement ≥1 Stage
NAS was the sum of the scores of steatosis, inflammation, and ballooning. NAS score ranged from 0 to 8, with higher scores indicating worse disease severity. Resolution of NASH was defined as the total absence of ballooning (score=0) and absent or mild inflammation (score=0 to 1). Fibrosis improvement was defined as ≥1-stage decrease in NASH CRN fibrosis score. NASH CRN fibrosis was staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis).
Measured: Week 24
Main Study: Number of Participants With at Least a 2-point Improvement in NAS Score and Are Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) Responders and Alanine Aminotransferase (ALT) Responders
A responder was defined as achieving ≥2 point improvement in NAS score and are MRI-PDFF responders and ALT responders at Week 24. NAS was the sum of the scores of steatosis, inflammation, and ballooning. NAS score ranged from 0 to 8, with higher scores indicating worse disease severity. MRI-PDFF responder was defined as ≥30% reduction from baseline in liver fat by MRI-PDFF. ALT responder was defined as ≥17 units/liter (U/L) or ≥30% reduction from baseline in ALT.
Measured: Week 24
Main Study: Percent Change From Baseline in Serum Triglycerides
Measured: Baseline, Week 24
Main Study: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-c)
Measured: Baseline, Week 24
Main Study: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-c)
Measured: Baseline, Week 24
Main Study: Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-c)
Measured: Baseline, Week 24
Main Study: Percent Change From Baseline in Adiponectin
Measured: Baseline, Week 24
Main Study: Percent Change From Baseline in HbA1c (Glycated Hemoglobin)
Measured: Baseline, Week 24
Main Study: Percent Change From Baseline in Alanine Transaminase
Measured: Baseline, Week 12 and 24
Main Study: Percent Change From Baseline in Hepatic Fat Fraction By Magnetic Resonance Imaging - (MRI-PDFF)
Measured: Baseline, Week 12 and 24
Main Study: Percent Change From Baseline in N-Terminal Type III Collagen Propeptide (Pro-C3)
Measured: Baseline, Week 12 and 24
Main Study: Trough Serum Concentration of Pegozafermin
Serum trough concentration (ng/mL) of pegozafermin taken from pre-dose samples.
Measured: Predose at Week 12 and 24
Main and Extension Study: Percent Change From Baseline in Alanine Transaminase
Baseline was prior to dosing on Day 1 of the main study.
Measured: Baseline, Week 48
Main and Extension Study: Percent Change From Baseline in N-Terminal Type III Collagen Propeptide (Pro-C3)
Baseline was prior to dosing on Day 1 of the main study.
Measured: Baseline, Week 48
Main and Extension Study: Percent Change From Baseline in Hepatic Fat Fraction By Magnetic Resonance Imaging - (MRI-PDFF)
Baseline was prior to dosing on Day 1 of the main study.
Measured: Baseline, Week 48
Main and Extension Study: Trough Serum Concentration of Pegozafermin
Serum trough concentration (ng/mL) of pegozafermin taken from pre-dose samples.
Measured: Predose at Week 48
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of IP, whether or not considered related to the IP. TEAEs were defined as AEs that started or worsened on or after the first dose of study IP up to Week 51. An SAE was an AE that met at least 1 of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization for the AE, persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect, important medical event or reaction. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Measured: Baseline up to Week 51

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jun 20218 Oct 2024

First posted18 Jun 2021
Study start4 Jun 2021
Primary completion14 Feb 2023
Study completion8 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for NASH - Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 222 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04929483
Sponsor's protocol ID: BIO89-100-122
Acronym: ENLIVEN
Status last verified: Dec 2025
First submitted: 10 Jun 2021
Last updated: 6 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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.
PubMed 37696614
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.
PubMed 37356033

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis
Active, not recruitingPhase 1/2
A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis
Active, not recruiting
Target of Suv420h1/2 in Hepatocytes
NAFLD
Active, not recruitingPhase 3
A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )
NASH - Nonalcoholic Steatohepatitis
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease Patients
NAFLD (Nonalcoholic Fatty Liver Disease)

All NASH - Nonalcoholic Steatohepatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT04929483
Acronym / sponsor ID: ENLIVEN / BIO89-100-122
Conditions: NASH - Nonalcoholic Steatohepatitis
Keywords: Liver Diseases, Fatty Liver, Digestive System Diseases, Non-alcoholic Fatty Liver Disease, Metabolic diseases, MASH MAFLD, NASH NAFLD
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 222 participants (actual)
Lead sponsor: 89bio, Inc.Industry (pharma, biotech, devices)
Study start: 4 Jun 2021 (actual)
Primary completion: 14 Feb 2023 (actual)
Study completion: 8 Oct 2024 (actual)
First posted: 18 Jun 2021 (actual)
Results: Posted 6 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
BIO89-100 - 15 mg once weekly (QW)	Experimental	Drug: BIO89-100
BIO89-100 - 30 mg QW	Experimental	Drug: BIO89-100
BIO89-100 - 44 mg once every 2 weeks (Q2W)	Experimental	Drug: BIO89-100
Placebo QW	Placebo comparator	Drug: Placebo
Placebo Q2W	Placebo comparator	Drug: Placebo
Placebo QW (Main study)/ BIO89-100 - 30 mg QW (Extension)	Experimental	Drug: BIO89-100, Drug: Placebo

Who may qualify

Ages: 21 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BIO89-100Also: PegozaferminSubcutaneous injection	Drug	BIO89-100 - 15 mg once weekly (QW), BIO89-100 - 30 mg QW, BIO89-100 - 44 mg once every 2 weeks (Q2W), Placebo QW (Main study)/ BIO89-100 - 30 mg QW (Extension)
PlaceboSubcutaneous injection	Drug	Placebo Q2W, Placebo QW, Placebo QW (Main study)/ BIO89-100 - 30 mg QW (Extension)

Primary outcome

Main Study: Number of Participants With Histological Resolution of Nonalcoholic Steatohepatitis (NASH) Without Worsening of Fibrosis
Time frame: Week 24
Nonalcoholic fatty liver disease activity score (NAS) was the sum of the scores of steatosis, inflammation, and ballooning. NAS score ranged from 0 to 8, with higher scores indicating worse disease severity. Resolution of NASH was defined as the total absence of ballooning (score=0) and absent or mild inflammation (score=0 to 1). NASH clinical research system (CRN) fibrosis is staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis). Worsening of fibrosis was defined as progression of fibrosis greater than or equal to (≥) 1 stage in NASH CRN fibrosis score.
Main Study: Number of Participants Who Achieved Improvement of Fibrosis ≥1 Stage Without Worsening of NASH
Time frame: Week 24
Worsening of NASH was defined as increase in nonalcoholic fatty liver disease activity score (NAS) for ballooning, inflammation, or steatosis. NAS was the sum of the scores of steatosis, inflammation, and ballooning. NAS score ranged from 0 to 8, with higher scores indicating worse disease severity. Fibrosis improvement was defined as ≥1-stage decrease in NASH CRN fibrosis score. NASH CRN fibrosis was staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis).

18 secondary outcomes

Main Study: Number of Participants With at Least a 2-Point Improvement in NAS and no Worsening of Fibrosis
Time frame: Week 24
Main Study: Number of Participants With NASH Resolution and Fibrosis Improvement ≥1 Stage
Time frame: Week 24
Main Study: Number of Participants With at Least a 2-point Improvement in NAS Score and Are Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) Responders and Alanine Aminotransferase (ALT) Responders
Time frame: Week 24
Main Study: Percent Change From Baseline in Serum Triglycerides
Time frame: Baseline, Week 24
Main Study: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-c)
Time frame: Baseline, Week 24
Main Study: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-c)
Time frame: Baseline, Week 24
Main Study: Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-c)
Time frame: Baseline, Week 24
Main Study: Percent Change From Baseline in Adiponectin
Time frame: Baseline, Week 24
Main Study: Percent Change From Baseline in HbA1c (Glycated Hemoglobin)
Time frame: Baseline, Week 24
Main Study: Percent Change From Baseline in Alanine Transaminase
Time frame: Baseline, Week 12 and 24
Main Study: Percent Change From Baseline in Hepatic Fat Fraction By Magnetic Resonance Imaging - (MRI-PDFF)
Time frame: Baseline, Week 12 and 24
Main Study: Percent Change From Baseline in N-Terminal Type III Collagen Propeptide (Pro-C3)
Time frame: Baseline, Week 12 and 24
Main Study: Trough Serum Concentration of Pegozafermin
Time frame: Predose at Week 12 and 24
Main and Extension Study: Percent Change From Baseline in Alanine Transaminase
Time frame: Baseline, Week 48
Main and Extension Study: Percent Change From Baseline in N-Terminal Type III Collagen Propeptide (Pro-C3)
Time frame: Baseline, Week 48
Main and Extension Study: Percent Change From Baseline in Hepatic Fat Fraction By Magnetic Resonance Imaging - (MRI-PDFF)
Time frame: Baseline, Week 48
Main and Extension Study: Trough Serum Concentration of Pegozafermin
Time frame: Predose at Week 48
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to Week 51

Results and safety

Results posted to the registry on 6 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Main and Extension Study: Pegozafermin 15 mg QW	21	20
Main and Extension Study: Pegozafermin 30 mg QW	73	59
Main and Extension Study: Pegozafermin 44 mg Q2W	57	51
Main Study: Placebo Pooled	71	63
Main and Extension Study: Placebo (Main) and Placebo (Extension) Only	0	0
Main and Extension Study: Placebo (Main) and Pegozafermin 30 mg QW (Extension)	0	0

Primary outcome: Main Study: Number of Participants With Histological Resolution of Nonalcoholic Steatohepatitis (NASH) Without Worsening of Fibrosis

Time frame: Week 24. Count of participants. Unit: Participants

Measure	Main Study: Pegozafermin 15 mg QW n = 14	Main Study: Pegozafermin 30 mg QW n = 53	Main Study: Pegozafermin 44 mg Q2W n = 43	Main Study: Placebo Pooled n = 54
Value	5	12	11	1

Main Study: Pegozafermin 15 mg QW vs Main Study: Placebo Pooled: Treatment Difference: 34.65 (95% CI 10.04 to 59.26), p <0.0001, Cochran-Mantel-Haenszel
Main Study: Pegozafermin 30 mg QW vs Main Study: Placebo Pooled: Treatment Difference: 20.89 (95% CI 9.05 to 32.72), p = 0.0009, Cochran-Mantel-Haenszel
Main Study: Pegozafermin 44 mg Q2W vs Main Study: Placebo Pooled: Treatment Difference: 23.61 (95% CI 10.04 to 37.18), p = 0.0005, Cochran-Mantel-Haenszel

Population analysed: Full analysis set (FAS) included all enrolled participants with confirmed fibrosis stage F2 or F3 and NAS ≥4 at baseline per independent review by a 3-pathologist panel who were eligible and assigned a randomization number in the study and received at least 1 dose of investigational product (IP). Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.

Primary outcome: Main Study: Number of Participants Who Achieved Improvement of Fibrosis ≥1 Stage Without Worsening of NASH

Time frame: Week 24. Count of participants. Unit: Participants

Measure	Main Study: Pegozafermin 15 mg QW n = 14	Main Study: Pegozafermin 30 mg QW n = 53	Main Study: Pegozafermin 44 mg Q2W n = 43	Main Study: Placebo Pooled n = 54
Value	3	14	11	4

Main Study: Pegozafermin 15 mg QW vs Main Study: Placebo Pooled: Treatment Difference: 14.45 (95% CI -8.71 to 37.62), p = 0.1039, Cochran-Mantel-Haenszel
Main Study: Pegozafermin 30 mg QW vs Main Study: Placebo Pooled: Treatment Difference: 18.87 (95% CI 5.24 to 32.50), p = 0.0085, Cochran-Mantel-Haenszel
Main Study: Pegozafermin 44 mg Q2W vs Main Study: Placebo Pooled: Treatment Difference: 20.33 (95% CI 5.26 to 35.40), p = 0.0077, Cochran-Mantel-Haenszel

Population analysed: FAS included all enrolled participants with confirmed fibrosis stage F2 or F3 and NAS ≥4 at baseline per independent review by a 3-pathologist panel who were eligible and assigned a randomization number in the study and received at least 1 dose of IP. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to Week 51. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Main and Extension Study: Pegozafermin 15 mg QW	1 of 21 (4.8%)	21 of 21 (100%)	0 of 21
Main and Extension Study: Pegozafermin 30 mg QW	5 of 72 (6.9%)	62 of 72 (86.1%)	0 of 72
Main and Extension Study: Pegozafermin 44 mg Q2W	8 of 57 (14%)	45 of 57 (78.9%)	0 of 57
Main and Extension Study: Placebo (Main) and Placebo (Extension) Only	6 of 50 (12%)	41 of 50 (82%)	0 of 50
Main and Extension Study: Placebo (Main) and Pegozafermin 30 mg QW (Extension)	2 of 19 (10.5%)	17 of 19 (89.5%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37696614Tseng 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.
Derived from this study: PubMed 37356033Loomba 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.

Related trials for NASH - Nonalcoholic Steatohepatitis

RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis
Active, not recruitingPhase 1/2
A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis
Active, not recruiting
Target of Suv420h1/2 in Hepatocytes
NAFLD
Active, not recruitingPhase 3
A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )
NASH - Nonalcoholic Steatohepatitis
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease Patients
NAFLD (Nonalcoholic Fatty Liver Disease)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Millie Gottwald, PharmD study director

89bio, Inc.

89 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BIO89-100 in people with NASH - Nonalcoholic Steatohepatitis, run by 89bio, Inc. at 89 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Main Study: Number of Participants With Histological Resolution of Nonalcoholic Steatohepatitis (NASH) Without Worsening of Fibrosis (time frame: Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04929483, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.