Caliway Biopharmaceuticals (TPE:6919) completed its U.S. FDA IND submission for a Phase 3b long-term follow-up study of its abdominal subcutaneous fat reduction drug, according to a Wednesday Taiwan Exchange filing.

The study, dubbed CBL-0303, is designed to evaluate long-term safety and maintenance of efficacy of the drug called CBL-514, before the trail.

It is expected to enroll around 300 participants in the United States. The protocol also includes an optional re-treatment phase for eligible patients, the filing said.