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ALG-055009 for Fatty Liver Disease (HERALD Trial)

Verified Trial
Phase 2
Recruiting
Led By Stephen Harrison, MD
Research Sponsored by Aligos Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
You have been diagnosed with Nonalcoholic Steatohepatitis
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks

Summary

This trial will test if taking ALG-055009 as a daily pill for 12 weeks is safe and effective.

Who is the study for?
This trial is for adults without liver scarring who have a condition called MASH, which is related to fat buildup in the liver. Participants should not have other serious health issues that could interfere with the study.
What is being tested?
The trial is testing ALG-055009, a new medication taken orally once daily for 12 weeks. It's being compared to a placebo (a pill with no active drug) to see if it's safe and effective for treating fatty liver diseases.
What are the potential side effects?
Specific side effects of ALG-055009 are not listed here, but common ones may include digestive discomfort, potential liver enzyme changes, and fatigue. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent relative change from baseline in liver fat content
Secondary study objectives
Absolute change from baseline in liver fat content
Proportion of subjects with normalization (<5%) in liver fat content
Proportion of subjects with ≥30% relative reduction in liver fat content
+2 more
Other study objectives
Change from baseline (absolute/percent) alanine aminotransferase (ALT)
Change from baseline (absolute/percent) aspartate aminotransferase (AST)
Change from baseline (absolute/percent) in SHBG
+7 more

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: ALG-055009 softgel capsule 0.9mgExperimental Treatment1 Intervention
ALG-055009 softgel capsule 0.9mg Daily for 12 weeks
Group II: ALG-055009 softgel capsule 0.7mgExperimental Treatment1 Intervention
ALG-055009 softgel capsule 0.7mg Daily for 12 weeks
Group III: ALG-055009 softgel capsule 0.5mgExperimental Treatment1 Intervention
ALG-055009 softgel capsule 0.5mg Daily for 12 weeks
Group IV: ALG-055009 softgel capsule 0.3mgExperimental Treatment1 Intervention
ALG-055009 softgel capsule 0.3mg Daily for 12 weeks
Group V: PlaceboPlacebo Group1 Intervention
Placebo softgel capsule Daily for 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ALG-055009
2021
Completed Phase 1
~100

Find a Location

Who is running the clinical trial?

Aligos TherapeuticsLead Sponsor
9 Previous Clinical Trials
845 Total Patients Enrolled
Stephen Harrison, MDPrincipal Investigator
8 Previous Clinical Trials
1,847 Total Patients Enrolled
~0 spots leftby Nov 2024
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