Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
102 participants
INTERVENTIONAL
2024-04-01
2024-09-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
TRIPLE
Study Groups
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ALG-055009 softgel capsule 0.3mg
ALG-055009 softgel capsule 0.3mg Daily for 12 weeks
ALG-055009
Softgel Capsule
ALG-055009 softgel capsule 0.5mg
ALG-055009 softgel capsule 0.5mg Daily for 12 weeks
ALG-055009
Softgel Capsule
ALG-055009 softgel capsule 0.7mg
ALG-055009 softgel capsule 0.7mg Daily for 12 weeks
ALG-055009
Softgel Capsule
ALG-055009 softgel capsule 0.9mg
ALG-055009 softgel capsule 0.9mg Daily for 12 weeks
ALG-055009
Softgel Capsule
Placebo
Placebo softgel capsule Daily for 12 weeks
Placebo
Softgel Capsule
Interventions
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ALG-055009
Softgel Capsule
Placebo
Softgel Capsule
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Aligos Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Stephen Harrison, MD
Role: PRINCIPAL_INVESTIGATOR
Locations
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Aligos Clinical Study Site 18
Chandler, Arizona, United States
Aligos Clinical Study Site 15
Peoria, Arizona, United States
Aligos Clinical Study Site 17
Tucson, Arizona, United States
Aligos Clinical Study Site 35
Chula Vista, California, United States
Aligos Clinical Study Site 1
Lincoln, California, United States
Aligos Clinical Study Site 37
Poway, California, United States
Aligos Clinical Study Site 10
Rialto, California, United States
Aligos Clinical Study Site 26
Bradenton, Florida, United States
Aligos Clinical Study Site 25
Clearwater, Florida, United States
Aligos Clinical Study Site 39
Fort Myers, Florida, United States
Aligos Clinical Study Site 2
Maitland, Florida, United States
Aligos Clinical Study Site 22
Ocoee, Florida, United States
Aligos Clinical Study Site 32
Port Orange, Florida, United States
Aligos Clinical Study Site 38
Sarasota, Florida, United States
Aligos Clinical Study Site 31
The Villages, Florida, United States
Aligos Clinical Study Site 3
Viera, Florida, United States
Aligos Clinical Study Site 30
Winter Park, Florida, United States
Aligos Clinical Study Site 23
Athens, Georgia, United States
Aligos Clinical Study Site 12
Topeka, Kansas, United States
Aligos Clinical Study Site 29
Louisville, Kentucky, United States
Aligos Clinical Study Site 24
Bastrop, Louisiana, United States
Aligos Clinical Study Site 5
Houma, Louisiana, United States
Aligos Clinical Study Site 4
Marrero, Louisiana, United States
Aligos Clinical Study Site 6
Metairie, Louisiana, United States
Aligos Clinical Study Site 14
Chesterfield, Michigan, United States
Aligos Clinical Study Site 7
New York, New York, United States
Aligos Clinical Study Site 8
Morehead City, North Carolina, United States
Aligos Clinical Study Site 21
Columbus, Ohio, United States
Aligos Clinical Study Site 16
Westlake, Ohio, United States
Aligos Clinical Study Site 36
East Greenwich, Rhode Island, United States
Aligos Clinical Study Site 9
Nashville, Tennessee, United States
Aligos Clinical Study Site 19
Austin, Texas, United States
Aligos Clinical Study Site 33
Bellaire, Texas, United States
Aligos Clinical Study Site 27
Brownsville, Texas, United States
Aligos Clinical Study Site 28
Edinburg, Texas, United States
Aligos Clinical Study Site 40
Farmers Branch, Texas, United States
Aligos Clinical Study Site 20
San Antonio, Texas, United States
Aligos Clinical Study Site 11
Waco, Texas, United States
Aligos Clinical Study Site 13
Manassas, Virginia, United States
Aligos Clinical Study Site 34
Seattle, Washington, United States
Countries
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Other Identifiers
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ALG-055009-303
Identifier Type: -
Identifier Source: org_study_id
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