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.
Study ID
NCT07659574
Phase
PHASE3
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

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

Interventions

  • UBT251 Injection 2.0 mg — DRUG
    UBT251 Injection subcutaneously once weekly
  • UBT251 Injection 4.0 mg — DRUG
    UBT251 Injection subcutaneously once weekly
  • UBT251 Injection 6.0 mg — DRUG
    UBT251 Injection subcutaneously once weekly
  • UBT251 Injection Placebo 2.0 mg — DRUG
    UBT251 Injection placebo subcutaneously once weekly
  • UBT251 Injection Placebo 4.0 mg — DRUG
    UBT251 Injection placebo subcutaneously once weekly
  • UBT251 Injection Placebo 6.0 mg — DRUG
    UBT251 Injection placebo subcutaneously once weekly

Study Details

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

Key Dates

First listed
Jun 22, 2026
Start date
Aug 10, 2026
Status verified
Jun 2026
Primary completion
Sep 24, 2027
Completion
Oct 22, 2027

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: UBT251 Injection 2.0 mg
    Each subject will receive UBT251 Injection s.c. once weekly for 36 weeks. Each dose group will be titrated starting from the initial dose, administered once weekly, and escalated to the next dose after 4 weeks until the target maintenance dose is reached, with a total treatment duration of 36 weeks.
  • Experimental: UBT251 Injection 4.0 mg
    Each subject will receive UBT251 Injection, s.c. once weekly for 36 weeks. Each dose group will be titrated starting from the initial dose, administered once weekly, and escalated to the next dose after 4 weeks until the target maintenance dose is reached, with a total treatment duration of 36 weeks.
  • Experimental: UBT251 Injection 6.0 mg
    Each subject will receive UBT251 Injection s.c. once weekly for 36 weeks. Each dose group will be titrated starting from the initial dose, administered once weekly, and escalated to the next dose after 4 weeks until the target maintenance dose is reached, with a total treatment duration of 36 weeks.
  • Placebo Comparator: UBT251 Injection Placebo 2.0 mg
    Each subject will receive UBT251 Injection Placebo, s.c. once weekly for 36 weeks. Each dose group will be titrated starting from the initial dose, administered once weekly, and escalated to the next dose after 4 weeks until the target maintenance dose is reached, with a total treatment duration of 36 weeks.
  • Placebo Comparator: UBT251 Injection Placebo 4.0 mg
    Each subject will receive UBT251 Injection Placebo, s.c. once weekly for 36 weeks. Each dose group will be titrated starting from the initial dose, administered once weekly, and escalated to the next dose after 4 weeks until the target maintenance dose is reached, with a total treatment duration of 36 weeks.
  • Placebo Comparator: UBT251 Injection Placebo 6.0 mg
    Each subject will receive UBT251 Injection Placebo, s.c. once weekly for 36 weeks. Each dose group will be titrated starting from the initial dose, administered once weekly, and escalated to the next dose after 4 weeks until the target maintenance dose is reached, with a total treatment duration of 36 weeks.

Primary Outcome Measure

HbA1c [ Time Frame: Week 36 ]

Central Contacts

Find similar trials

Nationwide
Type 2 diabetes trialsEndocrinology trialsMetabolic health trialsWeight loss trials

Related Studies