NCT04662164

A Study to Access the Efficacy in Type 2 Diabetes Mellitus on Stable Metformin

A Randomized, Double-blind, Placebo-Controlled, Repeat-Dose Study to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of L47 in Subjects With Type 2 Diabetes Mellitus on Stable Metformin

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Shanghai HEP Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Type 2 Diabetes Patients

Interventions

Type	Name	Description
DRUG	hepalatide	3 different dosage will be given sequentially to T2D patients

Timeline

• Start date: 2025-12-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2020-12-10
• Last updated: 2023-12-08