Evaluation of Efficacy, Safety and Tolerability of Aldafermin in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study In Subjects With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis (ALPINE 2/3)

Phase 2

Completed

• Conditions: NASH - Nonalcoholic Steatohepatitis
• Interventions: Biological: NGM282; Other: Placebo

• Registration Number: NCT03912532
• Lead Sponsor: NGM Biopharmaceuticals, Inc

Brief Summary

This is a multi-center evaluation of NGM282 in a randomized, double-blind, placebo-controlled study administered for 24 weeks in participants with histologically confirmed NASH and F2/F3 Fibrosis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-09
• Study First Submitted QC: 2019-04-09
• Study First Posted: 2019-04-11
• Study Start: 2019-05-16
• Primary Completion: 2021-03-04
• Study Completion: 2021-03-29
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-05
• Last Update Posted: 2022-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 171

Inclusion Criteria

1. Histologically confirmed NASH diagnosis as defined by the NASH CRN
2. Total liver fat content of ≥ 8% as measured by MRI-PDFF

Exclusion Criteria

1. Clinically significant acute or chronic liver disease of an etiology other than NASH
2. Evidence of drug-induced steatohepatitis secondary to amiodarone, corticosteroids, estrogens, methotrexate, tetracycline, or other medications known to cause hepatic steatosis
3. History or presence of cirrhosis (compensated or decompensated) as determined by histology and/or relevant medical complications and/or laboratory parameters
4. Prior or pending liver transplantation

Other protocol-defined inclusion/exclusion criteria could apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NGM282 Dose 2	NGM282	Administered by subcutaneous injection
NGM282 Dose 1	NGM282	Administered by subcutaneous injection
NGM282 Dose 3	NGM282	Administered by subcutaneous injection
Placebo	Placebo	Administered by subcutaneous injection

Primary Outcome Measures

Name	Time	Method
Proportion of participants achieving a histologic treatment effect (histologic response) as determined by the NASH CRN criteria after 24 weeks of NGM282 or matched placebo.	24 weeks
Evaluate safety and tolerability of NGM282 in participants with NASH as a function of dose level after up to 24 weeks of treatment with NGM282.	24 weeks

Trial Locations

Locations (1)

NGM Clinical Study Site; 🇵🇷 San Juan, Puerto Rico