← Back to Search

Other

ALG-055009 softgel capsule 0.7mg for Nonalcoholic Steatohepatitis (HERALD Trial)

Q: What is the cumulative count of individuals who are participating in this clinical study?

Yes, the details on clinicaltrials.gov indicate that this trial is currently seeking participants. It was initially listed on April 5th, 2024 and most recently revised on March 26th, 2024. The study aims to enroll 100 individuals at one location.

Q: Is the enrollment for participants currently open in this clinical trial?

Yes, details on clinicaltrials.gov indicate that this investigation is actively seeking participants. The trial was initially disclosed on April 5th, 2024, and last revised on March 26th, 2024. It aims to enroll a total of 100 patients at a single site.

Q: Are individuals aged 75 and above eligible to participate in this research study?

Participants eligible for this research project must be aged between 18 and 75 years old. It is worth noting that there are a total of 19 trials tailored to individuals under the age of 18, while there exist 197 studies dedicated to those above the age of 65.

Q: What is the safety profile of ALG-055009 softgel capsule 0.7mg in individuals?

The safety rating assigned to ALG-055009 softgel capsule 0.7mg by our team at Power is a 2, reflecting the current Phase 2 trial status with existing safety data but no evidence yet of efficacy.

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks

Awards & highlights

HERALD Trial 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.Check my eligibility

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.See study design

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.

HERALD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent relative change from baseline in liver fat content

Secondary outcome measures

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 outcome measures

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

HERALD 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Aligos TherapeuticsLead Sponsor

7 Previous Clinical Trials

805 Total Patients Enrolled

Stephen Harrison, MDPrincipal Investigator

8 Previous Clinical Trials

1,847 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cumulative count of individuals who are participating in this clinical study?

"Yes, the details on clinicaltrials.gov indicate that this trial is currently seeking participants. It was initially listed on April 5th, 2024 and most recently revised on March 26th, 2024. The study aims to enroll 100 individuals at one location."

Answered by AI

Is the enrollment for participants currently open in this clinical trial?

"Yes, details on clinicaltrials.gov indicate that this investigation is actively seeking participants. The trial was initially disclosed on April 5th, 2024, and last revised on March 26th, 2024. It aims to enroll a total of 100 patients at a single site."

Answered by AI

Are individuals aged 75 and above eligible to participate in this research study?

"Participants eligible for this research project must be aged between 18 and 75 years old. It is worth noting that there are a total of 19 trials tailored to individuals under the age of 18, while there exist 197 studies dedicated to those above the age of 65."

Answered by AI

What is the safety profile of ALG-055009 softgel capsule 0.7mg in individuals?

"The safety rating assigned to ALG-055009 softgel capsule 0.7mg by our team at Power is a 2, reflecting the current Phase 2 trial status with existing safety data but no evidence yet of efficacy."

Answered by AI