NCT07046273

Phase III Clinical Study on the Efficacy and Safety of Semaglutide and Ozempic® in Patients With Type 2 Diabetes

A Multicenter, Randomized, Open, Parallel-controlled, Phase III Clinical Study on the Efficacy and Safety of Semaglutide and Ozempic® in Patients With Type 2 Diabetes

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 496 (estimated)
• Sponsor: Shandong New Time Pharmaceutical Co., LTD · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, randomized, open, parallel-controlled, Phase III clinical study aimed to evaluate the efficacy and safety of semaglutide injection and Ozempic® in patients with type 2 diabetes.

Conditions

• Type 2 Diabetes (T2DM)

Interventions

Type	Name	Description
DRUG	F027	The starting dose is 0.25 mg once weekly. After 4 weeks the dose should be increased to 0.5 mg once weekly. After at least 4 weeks with a dose of 0.5 mg once weekly, the dose can be increased to 1 mg once weekly for 24 weeks.
DRUG	Ozempic®	The starting dose is 0.25 mg once weekly. After 4 weeks the dose should be increased to 0.5 mg once weekly. After at least 4 weeks with a dose of 0.5 mg once weekly, the dose can be increased to 1 mg once weekly for 24 weeks.

Timeline

• Start date: 2025-08-01
• Primary completion: 2028-08-01
• Completion: 2029-02-01
• First posted: 2025-07-01
• Last updated: 2025-07-01