UBT251 Injection Phase Ⅲ Study (Overweight or Obesity)

A PhaseⅢ Study to Evaluate the Efficacy and Safety of UBT251 Injection in Overweight/Obese Patients

This randomized, double-blind, parallel, placebo-controlled phase Ⅲ study to evaluate the efficacy and safety of UBT251 Injection in overweight/obese patients

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity & Overweight
• Intervention / Treatment: Drug: UBT251 Injection 4.0 mg; Drug: UBT251 Injection 6.0 mg; Drug: UBT251 Injection Placebo 4.0 mg; Drug: UBT251 Injection Placebo 6.0 mg

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Weilong Tao; Phone Number: 13770691686; Email: taowl@tul.com.cn

Study Locations

• China
  • Beijing, China
    • Peking University People's Hospital
    • Contact: Weinong Ji; Phone Number: 13910978815; Email: jiln@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria：

1. Age 18-75 years (inclusive) at the time of signing the informed consent form, regardless of gender;
2. Body mass index (BMI) ≥28.0 kg/m² (obesity) or 24.0 kg/m² ≤ BMI <28.0 kg/m² (overweight) at screening, accompanied by by at least one of the following: a. Prediabetes, hypertension, dyslipidemia, or fatty liver; b. Weight-bearing joint pain; c. Obesity-induced dyspnea or obstructive sleep apnea syndrome;
3. Self-reported having been on diet and exercise control for 3 months or more prior to screening, with body weight change ≤5 kg within the past 3 months;
4. Trial participants (including their partners) have no plan for pregnancy from screening to 6 months after trial completion, and are willing to comply with the contraceptive measures specified in the trial, and have no plan for sperm or egg donation within 6 months after trial completion;
5. Have been fully informed about this study and voluntarily sign a written informed consent form.

Exclusion Criteria:

1. Known history of hypersensitivity to this study drug, its drug product excipients, or other similar active drugs;

2. Any of the following medication history within 3 months before randomization:

   1. Treatment with dipeptidyl peptidase-4 (DPP-4) inhibitors, amylin analogs, glucagon-like peptide-1 (GLP-1) analogs, glucose-dependent insulinotropic polypeptide (GIP) analogs, or glucagon (GCG) analogs;
   2. Use of over-the-counter weight-loss medications or appetite suppressants (including traditional Chinese medicine, dietary supplements, meal replacements), or prescription weight-loss medications (including but not limited to orlistat) or lipolytic injections (e.g., fat-dissolving injections);
   3. Use of medications that may affect body weight for a duration of 1 week or longer, or anticipated use during the trial, including but not limited to systemic glucocorticoid therapy (intravenous or oral administration, except for the following: topical external use or intra-articular, intranasal, ophthalmic, and inhaled glucocorticoids; short-term [≤7 days] systemic glucocorticoid use for prevention or treatment of non-autoimmune allergic diseases, upper respiratory tract infection);
   4. Treatment with tricyclic antidepressants, antipsychotics, or antiepileptic medications;
   5. Treatment with antidiabetic medications;

3. History or evidence of any of the following diseases:

   1. Diagnosis of type 1, type 2 diabetes mellitus, or other types of diabetes mellitus (excluding history of gestational diabetes mellitus);
   2. Secondary obesity caused by diseases (including but not limited to elevated cortisol hormones [e.g., Cushing's syndrome], pituitary/hypothalamic injury, hypothyroidism, etc.) or medications (including but not limited to long-term glucocorticoid use, antidepressants, etc.);
   3. History of acute or chronic pancreatitis, or pancreatic surgery;
   4. History of symptomatic gallbladder disease within 1 year before screening (excluding trial participants who have undergone cholecystectomy [completed at least 3 months before screening] without long-term complications), or abdominal ultrasound at screening indicating large gallstones (diameter ≥2 cm), gallbladder polyps (diameter ≥1 cm), or other gallbladder lesions that the study physician determines may affect trial participant safety;
   5. Personal or family history (within first-degree relatives, i.e., parents, children, or siblings) of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2);
   6. Planned bariatric surgery during the trial or history of bariatric surgery, except for the following: a) acupuncture for weight loss or liposuction (e.g., abdominal liposuction) performed >1 year before screening; b) gastric banding, but the band was removed >1 year before screening; c) intragastric balloon, but the balloon was removed >1 year before screening; d) duodenal-jejunal bypass liner, but the liner was removed >1 year before screening;
   7. History of depression or severe mental illness (including but not limited to suicidal tendencies, schizophrenia, bipolar disorder, etc.);
   8. History of clinically significant cardiovascular or cerebrovascular disease within 6 months before screening;
   9. Severe retinal or macular disease (including but not limited to proliferative retinopathy, macular edema, retinal detachment, etc.) at screening or in the past, requiring urgent treatment as determined by the study physician;
   10. History of malignancy;
4. Blood loss ≥400 mL (including trauma, blood draw, blood donation) within 3 months before screening, or receipt of blood or blood component transfusion;
5. Lactating women or pregnant women;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UBT251 Injection 4.0 mg; Each subject will receive UBT251 Injection s.c. once weekly for 52 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 52 weeks.	Drug: UBT251 Injection 4.0 mg; UBT251 Injection subcutaneously once weekly
Experimental: UBT251 Injection 6.0 mg; Each subject will receive UBT251 Injection, s.c. once weekly for 52 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 52 weeks.	Drug: UBT251 Injection 6.0 mg; UBT251 Injection and UBT251 Injection Placebo subcutaneously once weekly
Placebo Comparator: UBT251 Injection Placebo 4.0 mg; Each subject will receive UBT251 Injection Placebo, s.c. once weekly for 52 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 52 weeks.	Drug: UBT251 Injection Placebo 4.0 mg; UBT251 Injection placebo subcutaneously once weekly
Placebo Comparator: UBT251 Injection Placebo 6.0 mg; Each subject will receive UBT251 Injection Placebo, s.c. once weekly for 52 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 52 weeks.	Drug: UBT251 Injection Placebo 6.0 mg; UBT251 Injection placebo subcutaneously once weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Weight	Percentage change in body weight from baseline after 52 weeks of treatment	Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waist Circumference	Changes from baseline in waist circumference at each visit	Through study completion, an average of one year
BMI	Changes from baseline in BMI at each visit	Through study completion, an average of one year
Systolic blood pressure	Changes from baseline in systolic blood pressure at each visit	Through study completion, an average of one year
Diastolic blood pressure	Changes from baseline in diastolic blood pressure at each visit	Through study completion, an average of one year
HbA1c	change in HbA1c from baseline after 12 weeks 、24 weeks 、32 week、52 weeks of treatment	Week 12 、Week 24、Week 32、Week 52
Fasting Serum Lipids	change in fasting serum lipids from baseline after 12 weeks 、24 weeks 、32 week、52 weeks of treatment	Week 12 、Week 24、Week 32、Week 52
SF-36 v2 scores	Changes from baseline in SF-36 v2 scores at Weeks 12, 24, 32, and 52	Week 12 、Week 24、Week 32、Week 52
Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) scores	Changes from baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) scores at Weeks 12, 24, 32, and 52	Week 12 、Week 24、Week 32、Week 52

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): July 31, 2026
• Primary Completion (Estimated): September 29, 2027
• Study Completion (Estimated): November 3, 2027

Study Registration Dates

• First Submitted: June 9, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: TUL-UBT251（III-1）202601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No