UBT37034 Injection safety study in adults with overweight or obesity

Inclusion Criteria:

* Aged 18-55 years (inclusive) at the time of informed consent form (ICF) signing;
* BMI ≥24 kg/m² at screening; weight \>60 kg (male) or \>50 kg (female) at screening;
* Self-reported ≥3 months of diet and exercise control before screening, with ≤5% weight change in the prior 3 months;
* The participant (and partner) has no plan for pregnancy from screening until 6 months after study completion. The participant is willing to use study-specified contraception. No sperm or egg donation is permitted within 6 months after study completion;
* Fully understands the study and provides voluntary written informed consent.

Exclusion Criteria:

* Suspected or confirmed hypersensitivity to components of products similar to the investigational product, or to any excipient of the investigational product; or subjects with allergic diathesis (multiple drug and food allergies).
* History of medication meeting any of the following criteria:

  1）Use of prescription drugs, over-the-counter drugs, vitamin products, or herbal medicines within 14 days prior to screening or within at least 5 half-lives (whichever is longer); stable fixed-dose antihypertensive or lipid-lowering medications that have been taken for at least 1 month and have no impact on glucose metabolism and body weight are permitted； 2) received vaccination within 1 month before screening or planned to receive vaccination during the study; 3) used weight-modifying medications within 3 months before screening, including but not limited to marketed or investigational anti-obesity agents (e.g., GLP-1 analogues, orlistat), agents with mechanism similar to neuropeptide Y receptor agonists, tricyclic antidepressants, psychotropic agents or sedatives (e.g., mirtazapine, paroxetine, olanzapine, valproic acid and its derivatives); 4) used antihyperglycemic drugs within 3 months before screening (including but not limited to metformin, SGLT2 inhibitors, thiazolidinediones \[TZDs\], etc.) or agents that may alter glucose metabolism (e.g., systemic glucocorticoids, growth hormone).
* History or evidence of any of the following conditions:

  1. Presence of clinically severe disease or clinically significant abnormality within 1 year prior to screening (including but not limited to disorders of the neuropsychiatric, cardiovascular, respiratory, hematologic and lymphatic, immune, renal, hepatic, gastrointestinal, metabolic, skeletal systems, etc.), which, in the opinion of the investigator, may compromise the safety of the trial participant, assessment of efficacy, or subject compliance;
  2. Diagnosis of type 1, type 2 diabetes mellitus, or other types of diabetes mellitus (history of gestational diabetes mellitus excluded);
  3. Secondary obesity caused by diseases (including but not limited to elevated cortisol \[e.g., Cushing syndrome\], pituitary/hypothalamic injury, hypothyroidism, etc.) or medications (including but not limited to long-term glucocorticoid use, antidepressants, etc.);
  4. History of clinically significant cardiovascular and cerebrovascular diseases within 6 months prior to screening, defined as:

     1. Myocardial infarction (MI) or unstable angina;
     2. Cardiac-related surgery (including coronary artery bypass grafting, percutaneous coronary intervention);
     3. Congestive heart failure (New York Heart Association (NYHA) Class III-IV);
     4. Cerebrovascular accident (old lacunar infarction excluded), including but not limited to hemorrhagic or ischemic stroke, or transient ischemic attack;
     5. Other cardiovascular and cerebrovascular diseases deemed unsuitable for participation in this trial as assessed by the investigator;
  5. Prior or current severe retinal or macular disease at screening (including but not limited to proliferative retinopathy, macular edema, retinal detachment, etc.) that requires urgent further treatment as judged by the investigator;
  6. History of severe hypoglycemia (hypoglycemia accompanied by severe cognitive impairment requiring other therapeutic interventions for recovery) or recurrent symptomatic hypoglycemia (≥2 episodes within 6 months);
  7. Gastrointestinal emptying disorders at screening (e.g., gastroparesis, pyloric obstruction, intestinal obstruction, etc.), gastrointestinal diseases assessed by the investigator to increase risks after study drug administration (e.g., severe active ulcer, inflammatory bowel disease, acute gastroenteritis, uncontrolled gastroesophageal reflux disease, etc.), or a history of major gastrointestinal surgery (excluding fully recovered procedures such as gastrointestinal polypectomy, appendectomy, cholecystectomy, etc., which are judged by the investigator not to affect trial safety);
  8. Prior history of depression, or a Patient Health Questionnaire-9 (PHQ-9) score ≥10 at screening, or history of severe psychiatric disorders (including but not limited to suicidal ideation, schizophrenia, bipolar disorder, etc.);
  9. Positive response to suicidal ideation Item 4 or Item 5, or any positive response to suicidal behavior-related questions on the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening;
  10. Major surgery, severe trauma, or severe infection within 1 month prior to screening, deemed unsuitable for this study by the investigator;
  11. Prior history of malignant neoplasm;12) Limb deformity or disability that prevents accurate measurement of height, weight, or other indicators.
* Abnormal laboratory findings at screening meeting any of the following:

  1. Glycated hemoglobin (HbA1c) ≥6.5% or fasting venous glucose ≥7.0 mmol/L. If the participant's fasting glucose during screening is 6.1-6.9 mmol/L, an oral glucose tolerance test (OGTT) is required for confirmation; subjects with a 2-hour post-load glucose ≥11.1 mmol/L will be excluded;
  2. Hepatic or renal impairment: serum alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥2 × upper limit of normal (ULN); serum total bilirubin ≥1.5 × ULN; estimated glomerular filtration rate (eGFR) \<90 mL·min-¹·1.73m-² (calculated using the CKD-EPI 2021 equation);
  3. Thyroid dysfunction that cannot be controlled with a stable drug dose (for ≥3 months), or clinically significant abnormalities in thyroid function tests at screening requiring initiation of treatment;
  4. Fasting triglycerides ≥5.6 mmol/L;
  5. Serum amylase and/or lipase \>2.0 × ULN;
  6. International normalized ratio (INR) greater than the upper limit of normal;
  7. Hemoglobin \<100 g/L;
  8. Systolic blood pressure ≥160 mmHg or \<90 mmHg, or diastolic blood pressure ≥100 mmHg or \<60 mmHg;
  9. Clinically significant electrocardiogram (ECG) abnormalities, such as:a) Second- or third-degree atrioventricular block;b) Long QT syndrome, or QT interval corrected using Fridericia's formula (QTcF) \>450 ms;c) Wolff-Parkinson-White syndrome;d) Heart rate \<50 beats per minute (bpm) or \>100 beats per minute (bpm);e) Other severe arrhythmias requiring treatment;
  10. Positive hepatitis B surface antigen, positive hepatitis C virus antibody, positive human immunodeficiency virus antibody, or positive syphilis antibody at screening;
  11. Clinically significant abnormalities identified on physical examination, laboratory tests, etc., who, in the investigator's judgment, may pose substantial risk to the trial participant or interfere with the evaluation of safety and pharmacokinetics (PK) results, rendering them unsuitable for participation in this trial.
* Participation in other interventional clinical trials within 3 months prior to screening (excluding those who only completed screening without randomization/enrollment, or those enrolled but did not receive study treatment);
* Blood loss ≥400 mL (including trauma, blood sampling, blood donation) within 3 months prior to screening, or received transfusion of blood or blood components;
* History of substance abuse, or positive urine drug screening;
* Smoked more than 5 cigarettes or equivalent tobacco products per day within 3 months prior to screening, or unable to abstain from smoking during the trial;
* Female subjects consuming \>7 standard drinks per week or male subjects consuming \>14 standard drinks per week within 28 days prior to screening (1 standard drink = 150 mL wine = 360 mL beer = 45 mL spirits), or consumed any alcohol-containing products within 48 hours before dosing, or had a positive breath alcohol test at the baseline visit, or unable to abstain from alcohol during the trial;
* Consumed excessive amounts of tea, coffee or caffeine-containing beverages (\>8 cups per day; 1 cup = 200 mL) within 14 days prior to screening, or consumed grapefruit, pomelo, or xanthine-rich foods/beverages; or unable to discontinue consumption of xanthine-rich foods or beverages (e.g., chocolate, tea, coffee, cola, etc.), grapefruit, pomelo, and products containing grapefruit or pomelo components (grapefruit juice, pomelo juice, etc.) from 48 hours prior to the first dose and throughout the trial period;
* Female subjects who are breastfeeding or pregnant;
* Intolerant to venipuncture, or with a history of vasovagal syncope triggered by needles or blood exposure;
* Unable to maintain regular diet and exercise during the trial, or other conditions deemed by the investigator to render the subject unsuitable for participation in this clinical trial.