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Not yet recruitingPhase 3

UBT251 Injection Phase Ⅲ Study (Overweight or Obesity)

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

Asset

UBT251

Subcutaneous · GLP-1 / GIP / glucagon triple

Listed sites

1

Recruiting sites

Enrollment

600

estimated

Study population

Obesity / overweight

Key I/E criterion

BMI ≥28

Primary endpoint

Body Weight

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07648225
Org study IDTUL-UBT251(III-1)202601

Timeline

Milestones

Study first posted2026-06-15actual
Last update posted2026-06-15actual
Study start2026-07-31estimated
Primary completion2027-09-29estimated
Study completion2027-11-03estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

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;

Endpoints (9)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
4
Cardiometabolic biomarkers
3
Glycemic / diabetes
1
Patient-reported / QoL
1

Weight & body composition

4 endpoints
Primary/protocol endpoint

Body Weight

Time frame:Week 52

descriptive

Secondary/protocol endpoint

Waist Circumference

Time frame:Through study completion, an average of one year

descriptive

Secondary/protocol endpoint

BMI

Time frame:Through study completion, an average of one year

descriptive

Secondary/protocol endpoint

Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) scores

Time frame:Week 12 、Week 24、Week 32、Week 52

descriptive

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

HbA1c

Time frame:Week 12 、Week 24、Week 32、Week 52

descriptive

Cardiometabolic biomarkers

3 endpoints
Secondary/protocol endpoint

Systolic blood pressure

Time frame:Through study completion, an average of one year

descriptive

Secondary/protocol endpoint

Diastolic blood pressure

Time frame:Through study completion, an average of one year

descriptive

Secondary/protocol endpoint

Fasting Serum Lipids

Time frame:Week 12 、Week 24、Week 32、Week 52

descriptive

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

SF-36 v2 scores

Time frame:Week 12 、Week 24、Week 32、Week 52

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.