ALG-055009 in Non-cirrhotic Adults With MASH (HERALD) (NCT06342947) | Clinical Trial Compass
CompletedPhase 2
ALG-055009 in Non-cirrhotic Adults With MASH (HERALD)
United States102 participantsStarted 2024-04-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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
What they're measuring
1
Percent relative change from baseline in liver fat content