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

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 thefollowing:

• 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 stiffnessmeasurement 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 metabolicdysfunction-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 therapyat 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