aldafermin for Non-Alcoholic Fatty Liver Disease (NAFLD)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Non-Alcoholic Fatty Liver Disease (NAFLD)+1 Morealdafermin - Biological
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

Study Summary

This trial evaluates aldafermin, a potential treatment for cirrhosis, in a group of patients with the disease. The study is double-blind, meaning that neither the patients nor the researchers know who is receiving the active drug or the placebo.

Eligible Conditions
  • Non-Alcoholic Fatty Liver Disease (NAFLD)
  • Compensated Liver Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 0 Secondary · Reporting Duration: 48 weeks

48 weeks
Improvement in Enhanced Liver Fibrosis (ELF) score.
Improvement in liver fibrosis of greater or equal to one stage with no worsening of NASH.
Safety assessed by reported and observed adverse events.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

4 Treatment Groups

Daily 1 mg dose
1 of 4
Daily 0.3 mg dose
1 of 4
Daily 3 mg dose
1 of 4
Placebo
1 of 4

Experimental Treatment

Non-Treatment Group

160 Total Participants · 4 Treatment Groups

Primary Treatment: aldafermin · Has Placebo Group · Phase 2

Daily 1 mg dose
Biological
Experimental Group · 1 Intervention: aldafermin · Intervention Types: Biological
Daily 0.3 mg dose
Biological
Experimental Group · 1 Intervention: aldafermin · Intervention Types: Biological
Daily 3 mg dose
Biological
Experimental Group · 1 Intervention: aldafermin · Intervention Types: Biological
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 48 weeks

Who is running the clinical trial?

NGM Biopharmaceuticals, IncLead Sponsor
23 Previous Clinical Trials
2,010 Total Patients Enrolled
NGM Study DirectorStudy DirectorNGM Biopharmaceuticals
9 Previous Clinical Trials
993 Total Patients Enrolled

Eligibility Criteria

Age 18 - 75 · All Participants · 3 Total Inclusion Criteria

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Who else is applying?

What state do they live in?
Ohio100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
How many prior treatments have patients received?
0100.0%