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CompletedPhase 2

UBT251 Injection Phase II Study (Overweight or Obesity)

A Phase II 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

205

actual

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 IDNCT07177469
Org study IDTUL-UBT251(Ⅱ-1)202404

Timeline

Milestones

Study start2025-03-14actual
Study first posted2025-09-17actual
Primary completion2025-10-22actual
Study completion2025-11-19actual
Last update posted2026-05-07actual

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 between 18 and 75 years, inclusive, of any gender;

2. Body mass index (BMI) ≥28.0 kg/m² or 24.0 kg/m² ≤ BMI < 28.0 kg/m² accompanied 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. Stable body weight for 3 months prior to screening;

4. No fertility plans from screening to 6 months after study completion, willing to use contraceptive measures, and no sperm or egg donation plans within 6 months after study completion;

5. Fully informed about the study and voluntarily signed the written informed consent form.

Exclusion criteria

1. Known hypersensitivity to the investigational drug or its formulation excipients, or to other GLP-1 receptor agonist drugs, or a history of clinically significant multiple or severe drug allergies, or current allergic diseases, or high sensitivity constitution;

2. History of use of any of the following drugs or treatments within the specified periods prior to screening: 1) GLP-1 receptor agonists, GLP-1R/GCGR agonists, or GLP-1R/GIPR/GCGR agonists within 3 months before screening; 2) Over-the-counter weight-loss drugs or appetite suppressants within 3 months before screening, or prescription weight-loss drugs or lipolytic injectables within 3 months before screening; 3) Drugs likely to affect body weight (e.g.systemic glucocorticoids, tricyclic antidepressants, antipsychotics, or antiepileptics) for ≥2 consecutive weeks within 3 months before screening or expected during the trial; 4) Antidiabetic drugs (e.g.metformin, SGLT2 inhibitors,thiazolidinediones) within 3 months before screening;

3. History or evidence of any of the following diseases: 1) Diagnosis of type 1 diabetes, type 2 diabetes, or other types of diabetes; 2) History of acute or chronic pancreatitis or pancreatic surgery; 3) Symptomatic gallbladder disease within 2 years before screening (defined as imaging evidence of gallstones with doctor-diagnosed abdominal pain attributable to gallstones); subjects who have undergone cholecystectomy and/or cholelithiasis treatment without long-term complications may participate; 4) Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2; 5) Secondary obesity due to disease or medication; 6) History of bariatric surgery (excluding: acupuncture for weight loss, liposuction, or abdominal liposuction performed >1 year before screening; gastric banding removed >1 year before screening; intragastric balloon removed >1 year before screening; duodenal-jejunal bypass sleeve removed >1 year before screening); 7) History of depression or Patient Health Questionnaire-9 (PHQ-9) score ≥15 at screening; or history of severe mental illness (including suicidal ideation/attempts, schizophrenia, bipolar disorder, etc.); 8) Clinically significant cardiovascular disease within 6 months before screening (defined as:

i.Myocardial infarction or unstable angina;
ii.Cardiac surgery;
iii.Congestive heart failure;
iv.Cerebrovascular accident, including stroke/transient ischemic attack;
v.Other cardiovascular diseases deemed unsuitable for the trial by the investigator); 9) History of retinal disease; 10) History of severe hypoglycemia or recurrent symptomatic hypoglycemia; 11) Concurrent gastroparesis or other gastrointestinal motility disorders, uncontrolled gastroesophageal reflux disease, or gastrointestinal diseases that increase the risk of adverse events with medication use; 12) Major surgery, severe trauma, or severe infection within 1 month before screening, as judged by the investigator to be unsuitable for the trial; 13) History of malignant tumors; 14) Limb deformities or disabilities that prevent accurate measurement of height, weight, or other indicators; 15) Concurrent diseases (e.g.neurological, endocrine, mental diseases) that, in the investigator's opinion, may affect subject safety, efficacy evaluation, or compliance;

4. Screening abnormalities in any of the following tests: 1) HbA1c ≥6.5% or fasting blood glucose (FBG) ≥7.0 mmol/L; if FBG is 6.1-6.9 mmol/L at screening, an oral glucose tolerance test (OGTT) is required, and subjects with 2-hour post-load blood glucose ≥11.1 mmol/L will be excluded; 2) Hepatic or renal impairment (serum ALT and/or AST ≥3 times the upper limit of normal [ULN]; serum total bilirubin ≥1.5×ULN; estimated glomerular filtration rate [eGFR] <60 mL·min-¹·1.73m-² according to local laboratory reference ranges); 3) Serum calcitonin ≥50 pg/mL; 4) Thyroid dysfunction (confirmed by clinical assessment and/or abnormal thyroid-stimulating hormone [TSH]) with hyperthyroidism or hypothyroidism that may increase patient risk; 5) Fasting triglycerides ≥5.6 mmol/L; 6) Serum amylase or lipase >2.0×ULN; 7) International normalized ratio (INR) above the normal range at screening; 8) Hemoglobin <110 g/L (male) or <100 g/L (female); 9) Untreated or poorly controlled hypertension; 10) Clinically significant electrocardiogram (ECG) abnormalities at screening; 11) Diagnosis of hypokalemia or hypomagnesemia at screening; 12) Physical examination, vital signs, or laboratory findings with clinically significant abnormalities that, in the investigator's judgment, pose a major risk to the subject or interfere with safety, pharmacokinetic (PK), or pharmacodynamic (PD) result evaluation;

5. Positive hepatitis B surface antigen (HBsAg) with hepatitis B virus (HBV) deoxyribonucleic acid (DNA) above the reference value, positive hepatitis C virus (HCV) antibody with HCV ribonucleic acid (RNA) exceeding the reference range upper limit, positive human immunodeficiency virus (HIV) antibody, or positive syphilis antibody at screening;

6. Blood loss or blood donation exceeding 400 mL within 3 months before screening, or receipt of blood or blood component transfusions; or concurrent hemoglobinopathies, hemolytic anemia, or sickle cell anemia;

7. Participation in other clinical trials within 3 months before screening;

8. History of drug or alcohol abuse, defined as female subjects consuming >7 standard drinks per week or male subjects consuming >14 standard drinks per week;

9. Pregnant or lactating women;

10. Inability to tolerate venipuncture or history of fainting or dizziness during blood draws;

11. Other conditions deemed unsuitable for participation in the clinical trial by the investigator.

Endpoints (17)

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

Other (unclassified)
5
Cardiometabolic biomarkers
4
Safety / tolerability / PK
4
Weight & body composition
3
Glycemic / diabetes
1

Weight & body composition

3 endpoints
Primary/protocol endpoint

Body Weight

Time frame:Week 24

descriptive

Secondary/protocol endpoint

Waist Circumference

Time frame:Week 24

descriptive

Secondary/protocol endpoint

BMI

Time frame:Week 24

descriptive

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

HbA1c

Time frame:Week 24

descriptive

Cardiometabolic biomarkers

4 endpoints
Secondary/protocol endpoint

Fasting Serum Lipids

Time frame:Week 24

descriptive

Secondary/protocol endpoint

Systolic blood pressure

Time frame:Week 24

descriptive

Secondary/protocol endpoint

Diastolic blood pressure

Time frame:Week 24

descriptive

Secondary/protocol endpoint

Pulse in beats per minute by investigator

Time frame:Through study completion, an average of six months

descriptive

Safety / tolerability / PK

4 endpoints
Secondary/protocol endpoint

Adverse Events

Time frame:Through study completion, an average of six months

descriptive

Secondary/protocol endpoint

Plasma Concentration

Time frame:Through study completion, an average of six months

concentration, descriptive

Secondary/protocol endpoint

ECG

Time frame:Through study completion, an average of six months

descriptive

Secondary/protocol endpoint

Abnormal findings in physical examination by investigator

Time frame:Through study completion, an average of six months

descriptive

Other (unclassified)

5 endpoints
Secondary/protocol endpoint/low confidence

Mental Health Status

Time frame:Through study completion, an average of six months

categorical status, descriptive

Secondary/protocol endpoint/low confidence

Serum Anti-UBT251 Antibody Incidence

Time frame:Through study completion, an average of six months

descriptive

Secondary/protocol endpoint/low confidence

Titre and neutralizing antibody testing of antibody-positive samples

Time frame:Through study completion, an average of six months

descriptive

Secondary/protocol endpoint/low confidence

Respiration in breaths per minute by investigator

Time frame:Through study completion, an average of six months

ratio, improvement

Secondary/protocol endpoint/low confidence

Temperature in degree Celsius by thermometer

Time frame:Through study completion, an average of six months

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.