UBT251 Injection Phase II (Type 2 Diabetes Mellitus) Study

NCT07163624 | Active Not Recruiting Phase 2

• 2 other identifiers: TUL-UBT251(Ⅱ-2)202405CTR20250029
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in HbA1c at Week 24

  HbA1c was obtained at baseline and at Week 24

  Baseline to week 24

Secondary Outcomes (12)

• Change Change from baseline to week 12, 16, 20 in HbA1c

  Week 12, 16, 20

• Change in venous fasting plasma glucose (FPG) from baseline to week 12, 16, 20, 24

  Week 12, 16, 20, 24

• Change in 2-hour post-standard-meal plasma glucose from baseline to week 12, 24

  Week 12, 24

• Change in body weight from baseline to week 12, 24

  Week 12, 24

• Change in waist circumference from baseline to week 12, 24

  Week 12, 24

Study Arms (5)

UBT251 Injection 2.0 mg

EXPERIMENTAL

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.

Drug: UBT251 Injection 2.0 mg and UBT251 Injection Placebo

UBT251 Injection 4.0 mg（ID 0.5 mg）

EXPERIMENTAL

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.

Drug: UBT251 Injection 4.0 mg (ID 0.5 mg) and UBT251 Injection Placebo

UBT251 Injection 4.0 mg（ID 1.0 mg）

EXPERIMENTAL

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.

Drug: UBT251 Injection 4.0 mg (ID 1.0 mg) and UBT251 Injection Placebo

UBT251 Injection 6.0 mg

EXPERIMENTAL

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.

Drug: UBT251 Injection 6.0 mg and UBT251 Injection Placebo

Semaglutide Injection （Ozempic®）1.0 mg

ACTIVE COMPARATOR

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.

Drug: Semaglutide Injection (Ozempic®)

Interventions

UBT251 Injection 2.0 mg and UBT251 Injection Placebo DRUG

UBT251 Injection and UBT251 Injection Placebo once weekly

UBT251 Injection 2.0 mg

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 0.5 mg）

UBT251 Injection 4.0 mg (ID 1.0 mg) and UBT251 Injection Placebo DRUG

UBT251 Injection and UBT251 Injection Placebo once weekly

UBT251 Injection 4.0 mg（ID 1.0 mg）

UBT251 Injection 6.0 mg and UBT251 Injection Placebo DRUG

UBT251 Injection and UBT251 Injection Placebo once weekly

UBT251 Injection 6.0 mg

Semaglutide Injection (Ozempic®) DRUG

Semaglutide Injection (Ozempic®) once weekly

Semaglutide Injection （Ozempic®）1.0 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years (inclusive) at the time of informed consent; sex not restricted.
• Documented diagnosis of type 2 diabetes mellitus with HbA1c ≥7.0% and ≤10.5% at screening.
• Lifestyle intervention or stable-dose metformin treatment (≥1000 mg/day) for at least 3 months before screening; "stable" defined as no change in daily dose during this period.
• Body weight: ≥50.0 kg for men and ≥45.0 kg for women at screening; body-mass index (BMI) 23.0-40.0 kg/m² (inclusive).
• Subject (and partner) agrees to use effective contraception from screening until 6 months after study completion and has no plans to donate sperm or ova during this period.
• Has been fully informed about the study and voluntarily signed the written informed consent form.

You may not qualify if:

• Known hypersensitivity to the investigational product or any of its excipients, to other GLP-1 receptor agonists, or history of clinically significant multiple or severe drug allergies; current allergic disease, high allergic disposition, or history of anaphylaxis.
• Prior use of any of the following medications:
• Any antihyperglycemic agent other than metformin within 3 months before screening, including GLP-1 analogues, oral antidiabetics, insulin, Chinese herbal medicines or health products with glucose-lowering effects.
• Systemic glucocorticoids, growth hormone, or any drug that may affect glucose metabolism within 3 months before screening.
• Any weight-loss medication within 3 months before screening.
• History or evidence of any of the following conditions:
• Diabetes other than type 2 (e.g., type 1 diabetes, specific types of diabetes).
• Acute or chronic pancreatitis, or history of pancreatic surgery.
• Symptomatic gallbladder disease within 2 years before screening (imaging-confirmed gallstones with physician-diagnosed related abdominal pain); subjects with prior cholecystectomy without sequelae may be included.
• Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
• Hematologic disorders that may interfere with HbA1c measurement or increase subject risk, or any disease causing hemolysis or red-cell instability.
• History of depression or severe psychiatric disorders including suicidal ideation/attempt, schizophrenia, or bipolar disorder.
• Clinically significant active cardiovascular or cerebrovascular disease within 6 months before screening: myocardial infarction or unstable angina; cardiac surgery; congestive heart failure; cerebrovascular accident including stroke/TIA; any other cardiovascular/cerebrovascular condition deemed unsuitable by the investigator.
• Retinopathy requiring urgent treatment at screening.
• History of severe hypoglycemic coma or recurrent hypoglycemia within 2 months before randomization.

Sponsors & Collaborators

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

Study Sites (1)

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

Zhuhai, Guangdong, 519000, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 9, 2025
• Study Start: March 22, 2025
• Primary Completion: December 12, 2025
• Study Completion: December 12, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)