Phase 1 Study of Multiple Subcutaneous Injections of B1344 for Adults With Nonalcoholic Fatty Liver Disease NAFLD

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and immune response of a drug called B1344 in patients with Nonalcoholic Fatty Liver Disease NAFLD. This randomized, double-blind, placebo-controlled trial also observes early signs of how B1344 might work as a treatment for Nonalcoholic Steatohepatitis NASH. The study is conducted across multiple centers and is led by Tasly Biopharmaceuticals Co., Ltd. Participants receive multiple subcutaneous injections of B1344 at varying doses 30 mg and 45 mg weekly, or 60 mg and 90 mg every two weeks. There is also a placebo group receiving injections on the same schedule. The trial is designed with escalating doses to assess different treatment levels safely. During the study, participants will have regular assessments including laboratory tests, MRI scans to measure liver fat, blood tests for liver enzymes and blood sugar control, and monitoring of any side effects. The main outcome measured is the frequency and severity of adverse events over 113 days. Secondary outcomes include drug concentration in the blood, changes in liver fat, triglycerides, body weight, and other metabolic markers, with total participation lasting about 90 to 113 days.

a Safety, Tolerability, and Pharmacokinetic Trial of Multiple Subcutaneous Injections of B1344 Injection in Patients With Nonalcoholic Fatty Liver Disease（NAFLD）