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

NCT04662164 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2023-12-08

No results posted yet for this study

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

DRUG

hepalatide

3 different dosage will be given sequentially to T2D patients

Sponsors & Collaborators

  • Shanghai HEP Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2025-12-31
Completion
2025-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04662164 on ClinicalTrials.gov