UBT251 Injection Phase II (Type 2 Diabetes Mellitus) Study

Sponsor
The United Bio-Technology (Hengqin) Co., Ltd.
Study ID
NCT07163624
Phase
PHASE2
Status
Completed

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • UBT251 Injection 2.0 mg and UBT251 Injection Placebo — DRUG
    UBT251 Injection and UBT251 Injection Placebo once weekly
  • UBT251 Injection 4.0 mg (ID 0.5 mg) and UBT251 Injection Placebo — DRUG
    UBT251 Injection and UBT251 Injection Placebo once weekly
  • UBT251 Injection 4.0 mg (ID 1.0 mg) and UBT251 Injection Placebo — DRUG
    UBT251 Injection and UBT251 Injection Placebo once weekly
  • UBT251 Injection 6.0 mg and UBT251 Injection Placebo — DRUG
    UBT251 Injection and UBT251 Injection Placebo once weekly
  • Semaglutide Injection (Ozempic®) — DRUG
    Semaglutide Injection (Ozempic®) once weekly

Study Details

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.

Key Dates

Start date
Mar 22, 2025
Status verified
May 2026
Primary completion
Nov 21, 2025
Completion
Dec 30, 2025

Study Design

Enrollment
211 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: UBT251 Injection 2.0 mg
    Each subject will receive UBT251 Injection and UBT251 Injection Placebo, s.c. once weekly for 24 weeks. The starting dose of UBT251 Injection will be 0.5 mg subcutaneous injection with increasing doses at 5, 9weeks to 1.0 mg and 2.0 mg once weekly.
  • Experimental: UBT251 Injection 4.0 mg（ID 0.5 mg）
    Each subject will receive UBT251 Injection and UBT251 Injection Placebo, s.c. once weekly for 24 weeks. The starting dose of UBT251 Injection will be 0.5 mg subcutaneous injection with increasing doses at 5, 9 and 13 weeks to 1.0 mg, 2.0 mg and 4.0 mg once weekly.
  • Experimental: UBT251 Injection 4.0 mg（ID 1.0 mg）
    Each subject will receive UBT251 Injection and UBT251 Injection Placebo, s.c. once weekly for 24 weeks. The starting dose of UBT251 Injection will be 1.0 mg subcutaneous injection with increasing doses at 5 and 9 weeks to 2.0 mg and 4.0 mg once weekly.
  • Experimental: UBT251 Injection 6.0 mg
    Each subject will receive UBT251 Injection and UBT251 Injection Placebo, s.c. once weekly for 24 weeks. The starting dose of UBT251 Injection will be 1.0 mg subcutaneous injection with increasing doses at 5, 9 and 13 weeks to 2.0 mg, 4.0 mg and 6.0 mg once weekly.
  • Active Comparator: Semaglutide Injection （Ozempic®）1.0 mg
    Each subject will receive Semaglutide Injection （Ozempic®）, s.c. once weekly for 24 weeks. The starting dose of Semaglutide Injection （Ozempic®） will be 0.25 mg subcutaneous injection with increasing doses at 5 and 9 weeks to 0.5 mg and 1.0 mg once weekly.

Primary Outcome Measure

Change From Baseline in HbA1c at Week 24 [ Time Frame: Baseline to week 24 ]

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