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NCT03912532 · ClinicalTrials.gov registry record · Phase 2
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 2 study of NASH - Nonalcoholic Steatohepatitis, sponsored by NGM Biopharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 171
- Enrollment target
- 20
- Study locations
NCT03912532: Completed Phase 2 study of NASH - Nonalcoholic Steatohepatitis, sponsored by NGM Biopharmaceuticals.
NCT03912532 is a Phase 2 study of NASH - Nonalcoholic Steatohepatitis that has completed, run by NGM Biopharmaceuticals. The registered enrollment target is 171 participants, below the 256-participant average among 28 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (33% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03912532, a Phase 2 study of NASH - Nonalcoholic Steatohepatitis, has completed, sponsored by NGM Biopharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 171 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Liver biopsies were collected at baseline and Week 24 and read by a central pathologist using Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) criteria. Fibrosis stages of F0, F1, F2, F3 and F4 are defined by NASH CRN criteria with F0 (minimal score) indicating no fibrosis and F4 (maximal score) indicating liver cirrhosis. Liver fibrosis response was defined as an improvement in liver fibrosis \>=1 stage with no worsening of steatohepatitis on liver biopsy at Week 24 compared wi
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL NGM282
Study Locations (20)
California
- NGM Clinical Study Site - Fresno
- NGM Clinical Study Site - La Jolla
- NGM Clinical Study Site - Los Angeles
- NGM Clinical Study Site - Los Angeles
- NGM Clinical Study Site - Poway
- NGM Clinical Study Site - Rialto
Florida
- NGM Clinical Study Site - Boca Raton
- NGM Clinical Study Site - Lakewood Rch
- NGM Clinical Study Site - Port Orange
- NGM Clinical Study Site - Sarasota
- NGM Clinical Study Site - The Villages
Arizona
- NGM Clinical Study Site - Chandler
- NGM Clinical Study Site 814 - Tucson
- NGM Clinical Study Site 816 - Tucson
Arkansas
- NGM Clinical Study Site - North Little Rock
Illinois
- NGM Clinical Study Site - Chicago
Louisiana
- NGM Clinical Study Site - Baton Rouge
Maryland
- NGM Clinical Study Site - Baltimore
Michigan
- NGM Clinical Study Site - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 171 participants |
| Start Date | 2019-05-16 |
| Est. Completion | 2021-03-29 |
| Phase | Phase 2 |
What the finished NCT03912532 record still lists
NCT03912532 is an interventional study that assigns participants to a tested intervention. The registered 171 participants enrollment target is mid-sized for trials with a published cap, below the 256-participant average among 28 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (33% lower).
The record links to 1 condition, with NASH - Nonalcoholic Steatohepatitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03912532 names 20 study sites across 9 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT03912532 about?
NCT03912532 is a clinical study titled "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)". 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.
What is the current status of trial NCT03912532?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 171 participants. The study started on 2019-05-16. Estimated completion is 2021-03-29.
What conditions does trial NCT03912532 study?
This clinical trial studies the following conditions: NASH - Nonalcoholic Steatohepatitis.
What interventions are being tested in trial NCT03912532?
The interventions under investigation include: Placebo (OTHER), NGM282 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03912532?
This trial is sponsored by NGM Biopharmaceuticals, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03912532 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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