A Study to Evaluate the Efficacy and Safety of Pegozaferm... | NCT06419374

Studies
A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH

NCT06419374

Sponsor

89bio, Inc.

Status

Recruiting

Last Update Posted

Jul 8, 2026Actual

Enrollment

762Estimated

Phase

Phase 3

Conditions

Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis

Interventions

Pegozafermin
Placebo

Countries

United States
Argentina
Australia
Belgium
Brazil
Bulgaria
Canada
France
Germany
Hong Kong
Hungary
India
Israel
Italy
Mexico
Netherlands
Poland
Puerto Rico
Singapore
South Korea
Spain
Taiwan
Turkey (Türkiye)
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 24, 2024Actual

Primary Completion Date

Jun 2028Estimated

Completion Date

Aug 2031Estimated

First Submitted Date

May 14, 2024

First Submission Date that Met QC Criteria

May 14, 2024

First Posted Date

May 17, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2026

Last Update Posted Date

Jul 8, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH [previously known as nonalcoholic steatohepatitis, NASH]).

Detailed Description

Not provided

Conditions Module

Conditions

Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis

Keywords

Liver disease
Fatty Liver
Digestive System Diseases
Metabolic diseases
Metabolic Dysfunction-Associated Steatohepatitis
MASH
Nonalcoholic steatohepatitis
NASH
Metabolic dysfunction-associated steatotic liver disease
MASLD
Nonalcoholic fatty liver disease
NAFLD
Fibrosis
Cirrhosis

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

762Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pegozafermin	Experimental		Biological: Pegozafermin
Placebo	Placebo Comparator	Matched placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pegozafermin	Biological	Subcutaneous injection	Pegozafermin	BIO89-100

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of Participants Achieving Fibrosis Regression	Fibrosis regression is defined as improvement in fibrosis by ≥1 stage, at Month 24 biopsy relative to baseline biopsy.	Baseline through Month 24
Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events		Baseline up to 5 years

Secondary Outcomes

Measure	Description	Time Frame
Change from Baseline in Enhanced Liver Fibrosis (ELF) Score		Baseline, up to Month 60
Change from Baseline in Alanine Aminotransferase (ALT) Level		Baseline, up to Month 60

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF).
Participants must have type 2 diabetes mellitus diagnosed at least 3 months before screening or at least 2 metabolic risk factors.
Biopsy-confirmed fibrosis stage F4 MASH (NASH Clinical Research Network (CRN) system) with compensated cirrhosis.
Body mass index (BMI) at screening ≥25.0 (≥23.0 for Asian participants) and <50.0 kilograms (kg)/meters squared (m^2).

Key Exclusion Criteria:

Liver disorder other than MASH.
History or evidence of hepatic decompensation.
History or evidence of hepatocellular carcinoma.
Have type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.
ALT or aspartate aminotransferase (AST) ≥250 units per liter (U/L).
Participants taking vitamin E (>400 international units [IU]/day) must be on stable dose for at least 6 months prior to screening.

Other protocol-defined inclusion and exclusion criteria may apply.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
ENLIGHTEN clinical trial	Contact	1-415-432-9270		enlighten@89bio.com

Overall Officials

Name	Affiliation	Role
Maya Margalit, MD	89bio, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
89bio Clinical Study Site	Recruiting	Birmingham	Alabama	35205	United States

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D065626	Non-alcoholic Fatty Liver Disease
D008107	Liver Diseases
D005234	Fatty Liver
D004066	Digestive System Diseases
D008659	Metabolic Diseases
D005355	Fibrosis

ID	Term
D009750	Nutritional and Metabolic Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms