RecruitingPhase 3NCT07659574

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

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)


Sponsor

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

Enrollment

360 participants

Start Date

Sep 7, 2026

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called UBT251 Injection 2.0 mg, a drug called UBT251 Injection 4.0 mg, and others for people with type 2 diabetes. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGUBT251 Injection 2.0 mg

UBT251 Injection subcutaneously once weekly

DRUGUBT251 Injection 4.0 mg

UBT251 Injection subcutaneously once weekly

DRUGUBT251 Injection 6.0 mg

UBT251 Injection subcutaneously once weekly

DRUGUBT251 Injection Placebo 2.0 mg

UBT251 Injection placebo subcutaneously once weekly

DRUGUBT251 Injection Placebo 4.0 mg

UBT251 Injection placebo subcutaneously once weekly

DRUGUBT251 Injection Placebo 6.0 mg

UBT251 Injection placebo subcutaneously once weekly


Locations(1)

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

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NCT07659574


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