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RECRUITING
NCT07659574
PHASE3

Phase III Study of UBT251 Injection in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Diet and Exercise Alone(UNIGUIDE-1)

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

View on ClinicalTrials.gov

Summary

This multicenter, randomized, double-Blind, parallel-group, placebo-controlled phase III trial is to evaluate the efficacy and safety of UBT251 Injection in patients with Type 2 Diabetes Mellitus with inadequate glycemic control on diet and exercise alone

Official title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase III Trial to Evaluate the Efficacy and Safety of UBT251 Injection in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Diet and Exercise Alone(UNIGUIDE-1)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

360

Start Date

2026-09-07

Completion Date

2027-10-22

Last Updated

2026-09-15

Healthy Volunteers

No

Conditions

Interventions

DRUG

UBT251 Injection 2.0 mg

UBT251 Injection subcutaneously once weekly

DRUG

UBT251 Injection 4.0 mg

UBT251 Injection subcutaneously once weekly

DRUG

UBT251 Injection 6.0 mg

UBT251 Injection subcutaneously once weekly

DRUG

UBT251 Injection Placebo 2.0 mg

UBT251 Injection placebo subcutaneously once weekly

DRUG

UBT251 Injection Placebo 4.0 mg

UBT251 Injection placebo subcutaneously once weekly

DRUG

UBT251 Injection Placebo 6.0 mg

UBT251 Injection placebo subcutaneously once weekly

Locations (1)

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China