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ACTIVE NOT RECRUITING
NCT07163624
PHASE2

UBT251 Injection Phase II (Type 2 Diabetes Mellitus) Study

Sponsor: The United Bio-Technology (Hengqin) Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

211

Start Date

2025-03-22

Completion Date

2025-12-12

Last Updated

2025-09-09

Healthy Volunteers

No

Interventions

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

Locations (1)

The United Bio-Technology (Hengqin) Co., Ltd.

Zhuhai, Guangdong, China