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NCT06258148Not yet recruiting

Phase 3 Study of TG103 Injection Monotherapy in Treatment of Type 2 Diabetes Mellitus

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Trial of TG103 Injection Monotherapy Subjects With Type 2 Diabetes Mellitus
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.Phase 3ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Type 2 Diabetes Mellitus
Drug/Device/Intervention
TG103
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Timeline & enrollment
Phase
Phase 3
Start date
Mar 01, 2024
End date
Nov 01, 2026
Enrollment
300 participants
Primary outcome

Changes in glycosylated hemoglobin (HbA1c) from baseline at 24 weeks of treatment

Summary

This is a randomized, double-blind, placebo-parallel, multicenter phase 3 clinical trial to
 evaluate the efficacy of TG103 injection 7.5mg and 15mg once a week monotherapy compared with
 placebo in subjects with type 2 diabetes with poor glycemic control after diet and exercise.

ICD-10 classifications
Type 2 diabetes mellitusType 2 diabetes mellitus with unspecified complicationsType 2 diabetes mellitus with other specified complicationsType 2 diabetes mellitus without complicationsType 2 diabetes mellitus with multiple complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06258148
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06258148 through Pure Global AI's free database. This Phase 3 trial is sponsored by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. and is currently Not yet recruiting. The study focuses on Type 2 Diabetes Mellitus. Target enrollment is 300 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.