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NASHPhase 2HERALDNCT06342947

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

A Phase 2 study testing ALG-055009 in people with NASH and MASH, run by Aligos Therapeutics at 40 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
ALG-055009
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
102 participants
Where
40 sitesUnited States
Study dates
1 Apr 2024to 9 Sep 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

40 sites in 1 country.

40 sites in 1 country

United States40 sites

  • Aligos Clinical Study Site 23

    Athens, Georgia, 30601

  • Aligos Clinical Study Site 19

    Austin, Texas, 73301

  • Aligos Clinical Study Site 24

    Bastrop, Louisiana, 71220

  • Aligos Clinical Study Site 33

    Bellaire, Texas, 77401

  • Aligos Clinical Study Site 26

    Bradenton, Florida, 34205

  • Aligos Clinical Study Site 27

    Brownsville, Texas, 78520

  • Aligos Clinical Study Site 18

    Chandler, Arizona, 85224

  • Aligos Clinical Study Site 14

    Chesterfield, Michigan, 48047

  • Aligos Clinical Study Site 35

    Chula Vista, California, 91902

  • Aligos Clinical Study Site 25

    Clearwater, Florida, 33755

  • Aligos Clinical Study Site 21

    Columbus, Ohio, 43004

  • Aligos Clinical Study Site 36

    East Greenwich, Rhode Island, 02818

  • Aligos Clinical Study Site 28

    Edinburg, Texas, 78504

  • Aligos Clinical Study Site 40

    Farmers Branch, Texas, 75006

  • Aligos Clinical Study Site 39

    Fort Myers, Florida, 33901

  • Aligos Clinical Study Site 5

    Houma, Louisiana, 70360

  • Aligos Clinical Study Site 1

    Lincoln, California, 95648

  • Aligos Clinical Study Site 29

    Louisville, Kentucky, 40018

  • Aligos Clinical Study Site 2

    Maitland, Florida, 32751, 32794

  • Aligos Clinical Study Site 13

    Manassas, Virginia, 20108

  • Aligos Clinical Study Site 4

    Marrero, Louisiana, 70072

  • Aligos Clinical Study Site 6

    Metairie, Louisiana, 70001

  • Aligos Clinical Study Site 8

    Morehead City, North Carolina, 28557

  • Aligos Clinical Study Site 9

    Nashville, Tennessee, 37011

  • Aligos Clinical Study Site 7

    New York, New York, 10001

  • Aligos Clinical Study Site 22

    Ocoee, Florida, 32703

  • Aligos Clinical Study Site 15

    Peoria, Arizona, 85301

  • Aligos Clinical Study Site 32

    Port Orange, Florida, 32119

  • Aligos Clinical Study Site 37

    Poway, California, 92025

  • Aligos Clinical Study Site 10

    Rialto, California, 92316

  • Aligos Clinical Study Site 20

    San Antonio, Texas, 78015

  • Aligos Clinical Study Site 38

    Sarasota, Florida, 34230

  • Aligos Clinical Study Site 34

    Seattle, Washington, 98039

  • Aligos Clinical Study Site 31

    The Villages, Florida, 32159

  • Aligos Clinical Study Site 12

    Topeka, Kansas, 66546

  • Aligos Clinical Study Site 17

    Tucson, Arizona, 85641

  • Aligos Clinical Study Site 3

    Viera, Florida, 32924

  • Aligos Clinical Study Site 11

    Waco, Texas, 76633

  • Aligos Clinical Study Site 16

    Westlake, Ohio, 44145

  • Aligos Clinical Study Site 30

    Winter Park, Florida, 32789

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
ALG-055009, Placebo
Keywords
NASH, MASH, Metabolic Dysfunction-Associated Steatohepatitis, Nonalcoholic Steatohepatitis, Liver, Fatty Liver Disease, Liver Disease, THR-B, THR B, THR-β, THR β
Medical subject headings
Non-alcoholic Fatty Liver Disease, Liver Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ALG-055009Drug

    Softgel Capsule

  • PlaceboDrug

    Softgel Capsule

Study groups in NCT06342947
Study groupRoleWhat they receive
ALG-055009 softgel capsule 0.3mgExperimentalALG-055009 softgel capsule 0.3mg Daily for 12 weeks
Receives: Drug: ALG-055009
ALG-055009 softgel capsule 0.5mgExperimentalALG-055009 softgel capsule 0.5mg Daily for 12 weeks
Receives: Drug: ALG-055009
ALG-055009 softgel capsule 0.7mgExperimentalALG-055009 softgel capsule 0.7mg Daily for 12 weeks
Receives: Drug: ALG-055009
ALG-055009 softgel capsule 0.9mgExperimentalALG-055009 softgel capsule 0.9mg Daily for 12 weeks
Receives: Drug: ALG-055009
PlaceboPlacebo comparatorPlacebo softgel capsule Daily for 12 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent relative change from baseline in liver fat content

    Percent relative change from baseline in liver fat content by MRI-PDFF at Week 12

    Measured: 12 weeks

Secondary outcomes (5)

  1. Absolute change from baseline in liver fat content

    Absolute change from baseline in liver fat content by MRI-PDFF at Week 12

    Measured: 12 weeks

  2. Proportion of subjects with ≥30% relative reduction in liver fat content

    Proportion of subjects with ≥30% relative reduction in liver fat content by MRI-PDFF at Week 12

    Measured: 12 weeks

  3. Proportion of subjects with ≥50% relative reduction in liver fat content

    Proportion of subjects with ≥50% relative reduction in liver fat content by MRI-PDFF at Week 12

    Measured: 12 weeks

  4. Proportion of subjects with ≥70% relative reduction in liver fat content

    Proportion of subjects with ≥70% relative reduction in liver fat content by MRI-PDFF at Week 12

    Measured: 12 weeks

  5. Proportion of subjects with normalization (<5%) in liver fat content

    Proportion of subjects with normalization (<5%) in liver fat content by MRI-PDFF at Week 12

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2024
  2. Study start1 Apr 2024
  3. Primary completion19 Aug 2024
  4. Study completion9 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06342947
Sponsor's protocol ID
ALG-055009-303
Acronym
HERALD
Status last verified
Feb 2025
First submitted
15 Mar 2024
Last updated
17 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Loomba R, Wang S, Desai D, Santillano D, Lucas KJ, Neff G, Bianco AC, Bruinstroop E, Su Y, Achneck HE, Le K, Fitzgerald M, Wu M, Lin TI, Chanda SM, Blatt LM, Mantzoros CS. ALG-055009 in non-cirrhotic adults with metabolic dysfunction-associated steatohepatitis (HERALD): a randomised, double-blind, placebo-controlled, phase 2a trial. Lancet Gastroenterol Hepatol. 2026 Aug 26:S2468-1253(26)00154-8. doi: 10.1016/S2468-1253(26)00154-8. Online ahead of print.

    PubMed 42648297

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ALG-055009 in people with NASH and MASH, run by Aligos Therapeutics at 40 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent relative change from baseline in liver fat content (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06342947, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.

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