## Protocol Section
### Identification Module
**NCT ID:** NCT06419374

**Brief Title:** Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH

**Official Title:** A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Compensated Cirrhosis Due to Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ENLIGHTEN-Cirrhosis)

#### Organization Study ID Info
**ID:** BIO89-100-132
#### Organization
**Class:** INDUSTRY
**Full Name:** 89bio, Inc.
### Status Module
#### Completion Date
**Date:** 2031-08

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2028-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** 89bio, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** True

### 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 \[previously known as nonalcoholic steatohepatitis, NASH\]).

### 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

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 762

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Biological: Pegozafermin

**Label:** Pegozafermin

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Matched placebo

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Pegozafermin

**Description:** Subcutaneous injection

**Name:** Pegozafermin

**Other Names:**

- BIO89-100

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Subcutaneous injection

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Fibrosis regression is defined as improvement in fibrosis by ≥1 stage, at Month 24 biopsy relative to baseline biopsy.

**Measure:** Proportion of Participants Achieving Fibrosis Regression

**Time Frame:** Baseline through Month 24

**Measure:** Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events

**Time Frame:** Baseline through Month 60

#### Secondary Outcomes

**Measure:** Change from Baseline in Enhanced Liver Fibrosis (ELF) Score

**Time Frame:** Baseline, Month 24 and Month 60

**Measure:** Change from Baseline in Alanine Aminotransferase (ALT) Level

**Time Frame:** Baseline, Month 24 and Month 60

**Measure:** Change from Baseline in FibroScan Vibration-controlled Transient Elastography (VCTE)

**Time Frame:** Baseline, Month 24 and Month 60

**Measure:** Proportion of Participants who Develop Clinically Significant Portal Hypertension (CSPH)

**Time Frame:** Baseline through Month 60

### 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).
* At least 1 metabolic risk factor.
* Biopsy-confirmed fibrosis stage F4 MASH (per non-alcoholic steatohepatitis \[NASH\] 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 inclusion and exclusion criteria may apply.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** enlighten@89bio.com

**Name:** ENLIGHTEN clinical trial

**Phone:** 1-415-432-9270

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** 89bio, Inc.

**Name:** Maya Margalit, MD

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000008107

- Term: Liver Diseases

- ID: D000004066

- Term: Digestive System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M11103

- Name: Liver Cirrhosis

- Relevance: HIGH

- As Found: Cirrhosis

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8375

- Name: Fatty Liver

- Relevance: HIGH

- As Found: Steatohepatitis

- ID: M8485

- Name: Fibrosis

- Relevance: HIGH

- As Found: Cirrhosis

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M30540

- Name: Non-alcoholic Fatty Liver Disease

- Relevance: HIGH

- As Found: Nonalcoholic Steatohepatitis

- ID: T5868

- Name: Visceral Steatosis

- Relevance: HIGH

- As Found: Steatohepatitis

### Condition Browse Module - Meshes

- ID: D000008103

- Term: Liver Cirrhosis

- ID: D000005234

- Term: Fatty Liver

- ID: D000065626

- Term: Non-alcoholic Fatty Liver Disease

- ID: D000005355

- Term: Fibrosis

### Intervention Browse Module - Browse Branches

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
