NCT07163624

UBT251 Injection Phase II (Type 2 Diabetes Mellitus) Study

A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of UBT251 Injection in Patients With Type 2 Diabetes Mellitus

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 211 (actual)
• Sponsor: The United Bio-Technology (Hengqin) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of UBT251 injection after 24 weeks of continuous administration in patients with type 2 diabetes mellitus and to recommend the dosing regimen for the Phase III clinical trial.

Conditions

• Type 2 Diabetes Mellitus (T2DM)

Interventions

Type	Name	Description
DRUG	UBT251 Injection 2.0 mg and UBT251 Injection Placebo	UBT251 Injection and UBT251 Injection Placebo once weekly
DRUG	UBT251 Injection 4.0 mg (ID 0.5 mg) and UBT251 Injection Placebo	UBT251 Injection and UBT251 Injection Placebo once weekly
DRUG	UBT251 Injection 4.0 mg (ID 1.0 mg) and UBT251 Injection Placebo	UBT251 Injection and UBT251 Injection Placebo once weekly
DRUG	UBT251 Injection 6.0 mg and UBT251 Injection Placebo	UBT251 Injection and UBT251 Injection Placebo once weekly
DRUG	Semaglutide Injection (Ozempic®)	Semaglutide Injection (Ozempic®) once weekly

Timeline

• Start date: 2025-03-22
• Primary completion: 2025-12-12
• Completion: 2025-12-12
• First posted: 2025-09-09
• Last updated: 2025-09-09

Locations

1 site across 1 country: China