NCT03912532

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)

A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy, Safety, and Tolerability of Three Doses of NGM282 Administered for 24 Weeks for the Treatment of Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: NGM Biopharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• NASH - Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
BIOLOGICAL	NGM282	NGM282
OTHER	Placebo	Placebo for NGM282

Timeline

• Start date: 2019-05-16
• Primary completion: 2021-03-04
• Completion: 2021-03-29
• First posted: 2019-04-11
• Last updated: 2025-07-03
• Results posted: 2025-07-03

Locations

37 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study