NCT05348122

A Study of TG103 Injection in Type 2 Diabetes Subjects

A Multicenter, Randomized, Double-blind, Placebo-controlled，Dulaglutide-controlled Phase Ⅱ Trial Exploring Optimal Dosing Regimen for TG103 Injection Monotherapy in Type 2 Diabetes

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this trial is to evaluate the efficacy of different doses and frequencies of administration of TG103 injection in the treatment of type 2 diabetes.

Detailed description

This trial is a randomized, double-blind, placebo-parallel, Dulaglutide-controlled，multicenter phase Ⅱ clinical trial. The whole trial consists of two parts, Part A and Part B, and 240 subjects are planned to be enrolled. Part A will be divided into three groups: TG103 15 mg group, TG103 22.5 mg group and placebo group, given once every two weeks (Q2W); Part B will be divided into four groups: TG103 7.5mg dose group, TG103 15 mg dose group ,placebo group and Dulaglutide group, once a week (QW). After Part A enrollment is completed, Part B will continue to be enrolled. The trial will include a screening period of up to 2 weeks, an initiation period of 2 weeks, a double-blind treatment period of 16 weeks, and a safety follow-up period of 3 weeks.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	TG103,Q2W	TG103 injection will be administered via subcutaneous injection once every two weeks in subjects with type 2 diabetes.
DRUG	TG103,QW	TG103 injection will be administered via subcutaneous injection once weekly in subjects with type 2 diabetes.
DRUG	Placebo,Q2W	Placebo will be administered via subcutaneous injection once every two weeks in subjects with type 2 diabetes.
DRUG	Placebo,QW	Placebo will be administered via subcutaneous injection once weekly in subjects with type 2 diabetes.
DRUG	Dulaglutide,QW	Dulaglutide will be administered via subcutaneous injection once weekly in subjects with type 2 diabetes.

Timeline

• Start date: 2022-06-15
• Primary completion: 2023-11-01
• Completion: 2023-11-01
• First posted: 2022-04-27
• Last updated: 2022-06-13

Locations

1 site across 1 country: China