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

NCT07659574 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2026-06-22

No results posted yet for this study

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

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

Sponsors & Collaborators

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

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-10
Primary Completion
2027-09-24
Completion
2027-10-22

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07659574 on ClinicalTrials.gov