ALG-055009 in Non-cirrhotic Adults With MASH (HERALD) (HERALD)

February 13, 2025 updated by: Aligos Therapeutics

A Randomized, Double-Blind, Placebo-Controlled Phase 2a Study Evaluating the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of ALG-055009 in Non-Cirrhotic Adults With Metabolic Dysfunction-Associated Steatohepatitis

This is a Phase 2a study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of oral (PO) daily (QD) doses of ALG-055009 (soft gelatin [softgel] capsule) for 12 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a double-blind, randomized, placebo-controlled Phase 2a study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of oral (PO) daily (QD) doses of ALG-055009 (soft gelatin [softgel] capsule) for 12 weeks. The study will be conducted in approximately 100 adult non-cirrhotic subjects with presumed MASH and liver fibrosis (F1-F3). The study will be conducted at up to approximately 45 sites throughout the United States of America.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Aligos Clinical Study Site 18
      • Peoria, Arizona, United States, 85301
        • Aligos Clinical Study Site 15
      • Tucson, Arizona, United States, 85641
        • Aligos Clinical Study Site 17
    • California
      • Chula Vista, California, United States, 91902
        • Aligos Clinical Study Site 35
      • Lincoln, California, United States, 95648
        • Aligos Clinical Study Site 1
      • Poway, California, United States, 92025
        • Aligos Clinical Study Site 37
      • Rialto, California, United States, 92316
        • Aligos Clinical Study Site 10
    • Florida
      • Bradenton, Florida, United States, 34205
        • Aligos Clinical Study Site 26
      • Clearwater, Florida, United States, 33755
        • Aligos Clinical Study Site 25
      • Fort Myers, Florida, United States, 33901
        • Aligos Clinical Study Site 39
      • Maitland, Florida, United States, 32751, 32794
        • Aligos Clinical Study Site 2
      • Ocoee, Florida, United States, 32703
        • Aligos Clinical Study Site 22
      • Port Orange, Florida, United States, 32119
        • Aligos Clinical Study Site 32
      • Sarasota, Florida, United States, 34230
        • Aligos Clinical Study Site 38
      • The Villages, Florida, United States, 32159
        • Aligos Clinical Study Site 31
      • Viera, Florida, United States, 32924
        • Aligos Clinical Study Site 3
      • Winter Park, Florida, United States, 32789
        • Aligos Clinical Study Site 30
    • Georgia
      • Athens, Georgia, United States, 30601
        • Aligos Clinical Study Site 23
    • Kansas
      • Topeka, Kansas, United States, 66546
        • Aligos Clinical Study Site 12
    • Kentucky
      • Louisville, Kentucky, United States, 40018
        • Aligos Clinical Study Site 29
    • Louisiana
      • Bastrop, Louisiana, United States, 71220
        • Aligos Clinical Study Site 24
      • Houma, Louisiana, United States, 70360
        • Aligos Clinical Study Site 5
      • Marrero, Louisiana, United States, 70072
        • Aligos Clinical Study Site 4
      • Metairie, Louisiana, United States, 70001
        • Aligos Clinical Study Site 6
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Aligos Clinical Study Site 14
    • New York
      • New York, New York, United States, 10001
        • Aligos Clinical Study Site 7
    • North Carolina
      • Morehead City, North Carolina, United States, 28557
        • Aligos Clinical Study Site 8
    • Ohio
      • Columbus, Ohio, United States, 43004
        • Aligos Clinical Study Site 21
      • Westlake, Ohio, United States, 44145
        • Aligos Clinical Study Site 16
    • Rhode Island
      • East Greenwich, Rhode Island, United States, 02818
        • Aligos Clinical Study Site 36
    • Tennessee
      • Nashville, Tennessee, United States, 37011
        • Aligos Clinical Study Site 9
    • Texas
      • Austin, Texas, United States, 73301
        • Aligos Clinical Study Site 19
      • Bellaire, Texas, United States, 77401
        • Aligos Clinical Study Site 33
      • Brownsville, Texas, United States, 78520
        • Aligos Clinical Study Site 27
      • Edinburg, Texas, United States, 78504
        • Aligos Clinical Study Site 28
      • Farmers Branch, Texas, United States, 75006
        • Aligos Clinical Study Site 40
      • San Antonio, Texas, United States, 78015
        • Aligos Clinical Study Site 20
      • Waco, Texas, United States, 76633
        • Aligos Clinical Study Site 11
    • Virginia
      • Manassas, Virginia, United States, 20108
        • Aligos Clinical Study Site 13
    • Washington
      • Seattle, Washington, United States, 98039
        • Aligos Clinical Study Site 34

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Male or female, 18 to 75 years of age
  • Body mass index (BMI) ≥ 25 kg/m2

  • Diagnosis of presumed NASH/MASH with F1-F3 liver fibrosis based on one of the following:

    • Liver biopsy within 6 months prior to screening showing a NAFLD activity score (NAS) of ≥4 with at least a score of 1 in each of the NAS components; OR
    • Having ≥2 metabolic syndrome criteria and a screening FibroScan liver stiffness measurement between 7 - 20 kPa
  • Screening FibroScan with CAP score of >300 dB/m
  • Screening MRI-PDFF with ≥10% liver fat content

Key Exclusion Criteria:

  • History or clinical evidence of chronic liver disease other than metabolic dysfunction-associated steatotic liver disease (MASLD)
  • History or current evidence of cirrhosis
  • History of liver transplantation or known planned liver transplantation
  • History or current evidence of a pituitary disorder or hyperthyroidism
  • Untreated clinical or subclinical hypothyroidism; or on thyroid replacement therapy at screening or within the last 6 months prior to screening.
  • TSH, free T4, or Total T3 >1.1 x ULN or <0.9 x LLN
  • Clinically concerning abnormal ECG or cardiac history
  • HbA1c ≥9.5%
  • Platelet count ≤135,000/mm3
  • ALT or AST >5 x ULN
  • INR >1.3
  • Albumin <3.5 g/dL
  • eGFR <45 mL/min/1.73 m2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ALG-055009 softgel capsule 0.3mg
ALG-055009 softgel capsule 0.3mg Daily for 12 weeks
Drug: ALG-055009
Softgel Capsule
Experimental: ALG-055009 softgel capsule 0.5mg
ALG-055009 softgel capsule 0.5mg Daily for 12 weeks
Drug: ALG-055009
Softgel Capsule
Experimental: ALG-055009 softgel capsule 0.7mg
ALG-055009 softgel capsule 0.7mg Daily for 12 weeks
Drug: ALG-055009
Softgel Capsule
Experimental: ALG-055009 softgel capsule 0.9mg
ALG-055009 softgel capsule 0.9mg Daily for 12 weeks
Drug: ALG-055009
Softgel Capsule
Placebo Comparator: Placebo
Placebo softgel capsule Daily for 12 weeks
Drug: Placebo
Softgel Capsule

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent relative change from baseline in liver fat content
Time Frame: 12 weeks
Percent relative change from baseline in liver fat content by MRI-PDFF at Week 12
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Absolute change from baseline in liver fat content
Time Frame: 12 weeks
Absolute change from baseline in liver fat content by MRI-PDFF at Week 12
12 weeks
Proportion of subjects with ≥30% relative reduction in liver fat content
Time Frame: 12 weeks
Proportion of subjects with ≥30% relative reduction in liver fat content by MRI-PDFF at Week 12
12 weeks
Proportion of subjects with ≥50% relative reduction in liver fat content
Time Frame: 12 weeks
Proportion of subjects with ≥50% relative reduction in liver fat content by MRI-PDFF at Week 12
12 weeks
Proportion of subjects with ≥70% relative reduction in liver fat content
Time Frame: 12 weeks
Proportion of subjects with ≥70% relative reduction in liver fat content by MRI-PDFF at Week 12
12 weeks
Proportion of subjects with normalization (<5%) in liver fat content
Time Frame: 12 weeks
Proportion of subjects with normalization (<5%) in liver fat content by MRI-PDFF at Week 12
12 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline (absolute/percent) in lipid/lipoprotein levels
Time Frame: 12 weeks
Change from baseline (absolute/percent) in lipid/lipoprotein levels at Week 12
12 weeks
Change from baseline (absolute/percent) in SHBG
Time Frame: up to 16 weeks
Change from baseline (absolute/percent) in SHBG
up to 16 weeks
Change from baseline (absolute/percent) alanine aminotransferase (ALT)
Time Frame: 12 weeks
Change from baseline (absolute/percent) in alanine aminotransferase (ALT) at Week 12
12 weeks
Change from baseline (absolute/percent) aspartate aminotransferase (AST)
Time Frame: 12 weeks
Change from baseline (absolute/percent) in aspartate aminotransferase (AST) at Week 12
12 weeks
Safety and tolerability will be assessed by monitoring TEAEs
Time Frame: 16 weeks
Safety and tolerability will be assessed by monitoring TEAEs
16 weeks
Safety and tolerability will be assessed by monitoring 12-lead electrocardiograms (ECGs)
Time Frame: 16 weeks
Safety and tolerability will be assessed by monitoring 12-lead electrocardiograms (ECGs)
16 weeks
PK parameters of ALG-055009 in plasma, AUCs
Time Frame: 12 weeks
PK parameters of ALG-055009 in plasma, AUCs
12 weeks
PK parameters of ALG-055009 in plasma, Tmax
Time Frame: 12 weeks
PK parameters of ALG-055009 in plasma, Tmax
12 weeks
PK parameters of ALG-055009 in plasma, Cmax
Time Frame: 12 weeks
PK parameters of ALG-055009 in plasma, Cmax
12 weeks
PK parameters of ALG-055009 in plasma, Cmin
Time Frame: 12 weeks
PK parameters of ALG-055009 in plasma, Cmin
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aligos Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stephen Harrison, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 19, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 9, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ALG-055009-303

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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