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

NCT06342947 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: ALG-055009-303
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 40

Brief 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.

Conditions

NASH; MASH; Metabolic Dysfunction-Associated Steatohepatitis; Nonalcoholic Steatohepatitis

Keywords

NASH; MASH; Metabolic Dysfunction-Associated Steatohepatitis; Nonalcoholic Steatohepatitis; Liver; Fatty Liver Disease; Liver Disease; THR-B; THR B; THR-β; THR β

Outcome Measures

Primary Outcomes (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

  12 weeks

Secondary Outcomes (5)

• Absolute change from baseline in liver fat content

  12 weeks

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

  12 weeks

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

  12 weeks

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

  12 weeks

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

  12 weeks

Other Outcomes (10)

• Change from baseline (absolute/percent) in lipid/lipoprotein levels

  12 weeks

• Change from baseline (absolute/percent) in SHBG

  up to 16 weeks

• Change from baseline (absolute/percent) alanine aminotransferase (ALT)

  12 weeks

Study Arms (5)

ALG-055009 softgel capsule 0.3mg

EXPERIMENTAL

ALG-055009 softgel capsule 0.3mg Daily for 12 weeks

Drug: ALG-055009

ALG-055009 softgel capsule 0.5mg

EXPERIMENTAL

ALG-055009 softgel capsule 0.5mg Daily for 12 weeks

Drug: ALG-055009

ALG-055009 softgel capsule 0.7mg

EXPERIMENTAL

ALG-055009 softgel capsule 0.7mg Daily for 12 weeks

Drug: ALG-055009

ALG-055009 softgel capsule 0.9mg

EXPERIMENTAL

ALG-055009 softgel capsule 0.9mg Daily for 12 weeks

Drug: ALG-055009

Placebo

PLACEBO COMPARATOR

Placebo softgel capsule Daily for 12 weeks

Drug: Placebo

Interventions

ALG-055009 DRUG

Softgel Capsule

ALG-055009 softgel capsule 0.3mg; ALG-055009 softgel capsule 0.5mg; ALG-055009 softgel capsule 0.7mg; ALG-055009 softgel capsule 0.9mg

Placebo DRUG

Softgel Capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aligos Therapeutics: lead

Study Sites (40)

Aligos Clinical Study Site 18

Chandler, Arizona, 85224, United States

Location

Aligos Clinical Study Site 15

Peoria, Arizona, 85301, United States

Location

Aligos Clinical Study Site 17

Tucson, Arizona, 85641, United States

Location

Aligos Clinical Study Site 35

Chula Vista, California, 91902, United States

Location

Aligos Clinical Study Site 1

Lincoln, California, 95648, United States

Location

Aligos Clinical Study Site 37

Poway, California, 92025, United States

Location

Aligos Clinical Study Site 10

Rialto, California, 92316, United States

Location

Aligos Clinical Study Site 26

Bradenton, Florida, 34205, United States

Location

Aligos Clinical Study Site 25

Clearwater, Florida, 33755, United States

Location

Aligos Clinical Study Site 39

Fort Myers, Florida, 33901, United States

Location

Aligos Clinical Study Site 2

Maitland, Florida, 32751, 32794, United States

Location

Aligos Clinical Study Site 22

Ocoee, Florida, 32703, United States

Location

Aligos Clinical Study Site 32

Port Orange, Florida, 32119, United States

Location

Aligos Clinical Study Site 38

Sarasota, Florida, 34230, United States

Location

Aligos Clinical Study Site 31

The Villages, Florida, 32159, United States

Location

Aligos Clinical Study Site 3

Viera, Florida, 32924, United States

Location

Aligos Clinical Study Site 30

Winter Park, Florida, 32789, United States

Location

Aligos Clinical Study Site 23

Athens, Georgia, 30601, United States

Location

Aligos Clinical Study Site 12

Topeka, Kansas, 66546, United States

Location

Aligos Clinical Study Site 29

Louisville, Kentucky, 40018, United States

Location

Aligos Clinical Study Site 24

Bastrop, Louisiana, 71220, United States

Location

Aligos Clinical Study Site 5

Houma, Louisiana, 70360, United States

Location

Aligos Clinical Study Site 4

Marrero, Louisiana, 70072, United States

Location

Aligos Clinical Study Site 6

Metairie, Louisiana, 70001, United States

Location

Aligos Clinical Study Site 14

Chesterfield, Michigan, 48047, United States

Location

Aligos Clinical Study Site 7

New York, New York, 10001, United States

Location

Aligos Clinical Study Site 8

Morehead City, North Carolina, 28557, United States

Location

Aligos Clinical Study Site 21

Columbus, Ohio, 43004, United States

Location

Aligos Clinical Study Site 16

Westlake, Ohio, 44145, United States

Location

Aligos Clinical Study Site 36

East Greenwich, Rhode Island, 02818, United States

Location

Aligos Clinical Study Site 9

Nashville, Tennessee, 37011, United States

Location

Aligos Clinical Study Site 19

Austin, Texas, 73301, United States

Location

Aligos Clinical Study Site 33

Bellaire, Texas, 77401, United States

Location

Aligos Clinical Study Site 27

Brownsville, Texas, 78520, United States

Location

Aligos Clinical Study Site 28

Edinburg, Texas, 78504, United States

Location

Aligos Clinical Study Site 40

Farmers Branch, Texas, 75006, United States

Location

Aligos Clinical Study Site 20

San Antonio, Texas, 78015, United States

Location

Aligos Clinical Study Site 11

Waco, Texas, 76633, United States

Location

Aligos Clinical Study Site 13

Manassas, Virginia, 20108, United States

Location

Aligos Clinical Study Site 34

Seattle, Washington, 98039, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Diseases

Condition Hierarchy (Ancestors)

Fatty Liver; Digestive System Diseases

Study Officials

• Stephen Harrison, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: April 2, 2024
• Study Start: April 1, 2024
• Primary Completion: August 19, 2024
• Study Completion: September 9, 2024
• Last Updated: February 17, 2025

Record last verified: 2025-02

Locations

US (40)