Galectin Therapeutics (GALT) said Tuesday it has reached an agreement with the US Food and Drug Administration on the key elements of a phase 3 trial of belapectin in metabolic dysfunction-associated steatohepatitis cirrhosis and portal hypertension.

The company said the regulator agreed during a type C meeting to a composite liver outcome, including prevention of development of large esophageal varices, as primary endpoint, and accepted the proposed blinded central review process for endoscopic assessment of esophageal varices.

Galectin said it plans to assess a single 2 mg dose of belapectin in the study and file its phase 3 protocol in Q3.

The company added that it is seeking strategic and financial partnerships to support development and commercialization.

Shares of the company were down 9% in premarket activity Tuesday.