UBT251 Injection Phase Ⅲ Study (Overweight or Obesity)

NCT07648225 | Not Yet Recruiting Phase 3

• 1 other identifier: TUL-UBT251（III-1）202601
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity & Overweight

Outcome Measures

Primary Outcomes (1)

• Body Weight

  Percentage change in body weight from baseline after 52 weeks of treatment

  Week 52

Secondary Outcomes (8)

• Waist Circumference

  Through study completion, an average of one year

• BMI

  Through study completion, an average of one year

• Systolic blood pressure

  Through study completion, an average of one year

• Diastolic blood pressure

  Through study completion, an average of one year

• HbA1c

  Week 12 、Week 24、Week 32、Week 52

Study Arms (4)

UBT251 Injection 4.0 mg

EXPERIMENTAL

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 6.0 mg

EXPERIMENTAL

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 Placebo 4.0 mg

PLACEBO COMPARATOR

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 6.0 mg

PLACEBO COMPARATOR

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

Interventions

UBT251 Injection 4.0 mg DRUG

UBT251 Injection subcutaneously once weekly

UBT251 Injection 4.0 mg

UBT251 Injection 6.0 mg DRUG

UBT251 Injection and UBT251 Injection Placebo subcutaneously once weekly

UBT251 Injection 6.0 mg

UBT251 Injection Placebo 4.0 mg DRUG

UBT251 Injection placebo subcutaneously once weekly

UBT251 Injection Placebo 4.0 mg

UBT251 Injection Placebo 6.0 mg DRUG

UBT251 Injection placebo subcutaneously once weekly

UBT251 Injection Placebo 6.0 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 signing the informed consent form, regardless of gender;
• 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;
• 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;
• 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;
• Have been fully informed about this study and voluntarily sign a written informed consent form.

You may not qualify if:

• Known history of hypersensitivity to this study drug, its drug product excipients, or other similar active drugs;
• Any of the following medication history within 3 months before randomization:
• 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;
• 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);
• 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);
• Treatment with tricyclic antidepressants, antipsychotics, or antiepileptic medications;
• Treatment with antidiabetic medications;
• History or evidence of any of the following diseases:
• Diagnosis of type 1, type 2 diabetes mellitus, or other types of diabetes mellitus (excluding history of gestational diabetes mellitus);
• 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.);
• History of acute or chronic pancreatitis, or pancreatic surgery;
• 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;
• 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);
• 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;
• History of depression or severe mental illness (including but not limited to suicidal tendencies, schizophrenia, bipolar disorder, etc.);

Sponsors & Collaborators

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

Study Sites (1)

Peking University People's Hospital

Beijing, China

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Weilong Tao

CONTACT

13770691686; taowl@tul.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 15, 2026
• Study Start (Estimated): July 31, 2026
• Primary Completion (Estimated): September 29, 2027
• Study Completion (Estimated): November 3, 2027
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)