Phase III Study of UBT251 Injection in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin ± Sulfonylurea/SGLT2 Inhibitor Therapy (UNIGUIDE-2)

NCT07653477 · Not yet recruiting

Last updated 2026-07-12

This clinical trial is testing the safety and effectiveness of the experimental drug UBT251 injection in adults with type 2 diabetes whose blood sugar levels are not well controlled with metformin alone or combined with other diabetes medications.

Status Not yet recruiting Approved but enrollment has not started.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 956 people Planned (estimated).

Who can join Ages 18–75 · all sexes

Timeline Started 2026-07 · est. completion 2028-02

What this study is testing ClinicalTrials.gov NCT07653477 ↗

Description as written by the study sponsor.

This study is a multicenter, randomized, open-label, parallel-group, semaglutide injection-controlled clinical trial. It aims to evaluate the non-inferiority of UBT251 Injection in glycemic control compared with Semaglutide Injection after 36 weeks of continuous administration in study participants with Type 2 Diabetes Mellitus (T2DM) and inadequate glycemic control on oral antidiabetic medications.A total of 956 participants are planned to be enrolled, including the UBT251 Injection 2 mg group, 4 mg group, 6 mg group, and Semaglutide group，with an approximate study duration of 58 weeks per participant.

Treatments tested

UBT251 Injection 2.0 mg group Drug

UBT251 Injection subcutaneously once weekly
UBT251 Injection 4.0 mg group Drug

UBT251 Injection subcutaneously once weekly
UBT251 Injection 6.0 mg group Drug

UBT251 Injection subcutaneously once weekly
Semaglutide Injection Drug

Semaglutide Injection subcutaneously once weekly

Main thing measured	HbA1c
Sponsor	The United Bio-Technology (Hengqin) Co., Ltd.
Conditions studied	Type 2 Diabetes
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07653477 ↗