Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH (ENLIGHTEN-Cirrhosis)

Phase 3

Recruiting

Conditions: Metabolic Dysfunction-Associated Steatohepatitis (MASH) with Compensated Cirrhosis

Registration Number: 2023-510395-31-00

Lead Sponsor: 89bio Inc.

Brief Summary: At interim analysis: To evaluate the effect of pegozafermin compared to placebo on regression of fibrosis at 24 months relative to baseline biopsy.

At study completion: To evaluate the effect of pegozafermin compared to placebo in reducing the risk of clinical outcomes measured as a composite endpoint

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing, recruiting

Sex: Not specified

Target Recruitment: 155

Inclusion Criteria

1_Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF)

2_Presence of at least one metabolic risk factor

3_Biopsy-confirmed fibrosis stage F4 MASH (per non-alcoholic steatohepatitis [NASH] Clinical Research Network (CRN) system) with compensated cirrhosis

4_Body mass index (BMI) at Screening ≥25.0 (≥23.0 for Asian subjects) and <50.0 kg/m2

Exclusion Criteria

1_Liver disorder other than MASH

2_History or evidence of hepatic decompensation

3_History or evidence of hepatocellular carcinoma

4_Have type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus

5_ALT or aspartate aminotransferase (AST) ≥250 units per liter (U/L)

6_Participants taking vitamin E (>400 international units [IU]/day) must be on stable dose for at least 6 months prior to screening

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
1_At interim analysis: Proportion of subjects achieving fibrosis regression, defined as improvement in fibrosis by ≥1 stage, at Month 24 biopsy relative to baseline biopsy		1_At interim analysis: Proportion of subjects achieving fibrosis regression, defined as improvement in fibrosis by ≥1 stage, at Month 24 biopsy relative to baseline biopsy
2_At study completion: Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events		2_At study completion: Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events

Secondary Outcome Measures

Name	Time	Method
4_At study completion: Proportion of subjects who develop CSPH		4_At study completion: Proportion of subjects who develop CSPH
1_At interim analysis and study completion: Change from baseline in ELF score		1_At interim analysis and study completion: Change from baseline in ELF score
2_At interim analysis and study completion: Change from baseline in ALT		2_At interim analysis and study completion: Change from baseline in ALT
3_At interim analysis and study completion: Change from baseline in FibroScan VCTE		3_At interim analysis and study completion: Change from baseline in FibroScan VCTE

Trial Locations

Locations (64): Santa Sp. z o.o.
🇵🇱
Lodz, Poland
ID Clinic Arkadiusz Pisula
🇵🇱
Myslowice, Poland
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego W Katowicach
🇵🇱
Katowice, Poland
Futuremeds Sp. z o.o.
🇵🇱
Warsaw, Poland
Krakowskie Centrum Medyczne Sp. z o.o.
🇵🇱
Cracow, Poland
Medical Network Sp. z o.o.
🇵🇱
Warsaw, Poland
Umbal - Prof. D-R Stoyan Kirkovich AD
🇧🇬
Stara Zagora, Bulgaria
Acibadem City Clinic Tokuda University Hospital EAD
🇧🇬
Sofiya, Bulgaria
Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD
🇧🇬
Gorna Oryahovitsa, Bulgaria
Diagnostic Consultative Centre Ascendent EOOD
🇧🇬
Sofia, Bulgaria
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Santa Sp. z o.o.
🇵🇱Lodz, Poland
Maciej Jabłkowski
Site contact
508489097
badania.kliniczne@swietarodzina.com.pl