Shanghai Hepu Biotechnology Co., Ltd.

This is a randomized, double-blind, placebo-controlled, repeat-dose study to evaluate the safety, tolerability, PK, and PD of L47 as an add-on treatment to stable metformin therapy in patients with T2DM. Approximately 30 subjects will be randomized into the study at up to two investigational sites. The study includes a screening period of up to 28 days, with a three-day, single-blind, placebo lead-in period; a four-week, double-blind treatment period; and a one-week follow-up period. There will be 2 inpatient stays (Day -3 to 2 and 27 to 29) and daily outpatient visits during treatment period. During the follow-up period, there will be 1 outpatient visit at the end of the study. There will be 3 cohorts of 10 subjects each to be enrolled sequentially. In each cohort, subjects will be randomized in a 4:1 ratio to receive either L47 or placebo subcutaneously. Subjects will monitor fasting capillary glucose (finger sticks or self-monitoring of blood glucose, SMBG) during the lead-in, treatment, and follow-up periods.

The goal of this clinical trial is to evaluate the efficacy and safety of L47 in the treatment of chronic hepatitis D. Patients with compensated CHD who satisfy the eligibility criteria are stratified by the presence or absence of liver cirrhosis and randomized into three groups at a 1:1:1 ratio. The subjects will receive continuous L47 (2.1 mg/d and 4.2 mg/d, s.c.) treatment for 48 weeks (groups A and B), or delayed treatment for 48 weeks (group C). Primary endpoint evaluation will be performed after the subjects complete the 48-week treatment.

1）初步探索贺普拉肽治疗慢性丁型肝炎的有效性； 2）初步探索贺普拉肽治疗慢性丁型肝炎的安全性。