Overweight/Obesity
Conditions
Interventions
Group 1:UBT37034 for injection: 2 cases
under fasting condition (fasting for at least 10 h before administration, except for water intake) and in the supine position, UBT37034 0.05 mg was administered via subcutaneous injection at the abdom
Group 2:UBT37034 for injection: 8 cases / placebo: 2 cases
under fasting conditions (fasting for at least 10 h before administration, water intake permitted), subjects were placed in the supine position for subcutaneous injection of UBT37034 0.2 mg or placebo
Group 3:UBT37034 for injection: 8 cases / placebo: 2 cases
under fasting conditions (fasting for at least 10 h before administration, water intake permitted), subjects were placed in the supine position for subcutaneous injection of UBT37034 0.5 mg or placebo
Group 4:UBT37034 for injection: 8 cases / placebo: 2 cases
under fasting conditions (fasting
Sponsors
The Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. When signing the informed consent form, the age range is 18-55 years (inclusive), regardless of gender; 2. During the screening period, male weight >60 kg and female weight >50 kg. Healthy subjects have a BMI of 19 kg/m^2 <= BMI <24 kg/m^2; overweight/obese subjects have a BMI of 24 kg/m^2 <= BMI <=35 kg/m^2; 3. Maintain stable weight within 3 months prior to randomization (weight change <5%); 4. No adjustment of diet or any measures to change nutritional lifestyle within 3 months prior to randomization; 5. Subjects are willing to voluntarily use appropriate and effective contraceptive measures from the time of signing the informed consent form until 3 months after administration of the investigational drug (see Appendix 3). No plan to donate sperm or eggs within 3 months after administration of the investigational drug; 6. Subjects are able to communicate effectively with the investigators, fully understand the study, voluntarily participate, and comply with all study requirements, having signed a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Known allergy to the investigational drug or its excipients, or to neuropeptide Y receptor agonists or biologics; or current allergic disease or hypersensitivity constitution; 2. Use of weight-affecting drugs within 3 months prior to screening, including but not limited to: (1) Drugs with a mechanism of action similar to neuropeptide Y receptor agonists for weight loss or glucose-lowering; (2) Approved or investigational weight-loss drugs (e.g., GLP-1 analogs, orlistat, etc.); (3) Tricyclic antidepressants, psychiatric drugs, or sedatives (e.g., mirtazapine, paroxetine, olanzapine, valproate and its derivatives); (4) Systemic corticosteroids (intravenous/oral/intra-articular injection); 3. Use of any over-the-counter drugs, prescription drugs, traditional Chinese medicine, and/or nutritional supplements within 14 days prior to dosing, or planned use during the study of the following: (1) Drugs reducing gastrointestinal motility, including but not limited to anticholinergics, antispasmodics, 5-HT3 receptor antagonists, dopamine antagonists, and opioids; (2) Drugs known to prolong QT/QTc interval; (3) Vaccination within 1 month prior to screening or planned vaccination during the trial; (4) Other drugs that may affect trial evaluation; 4. History or evidence of any of the following conditions: (1) Diagnosed with type 1 or type 2 diabetes, gestational diabetes, or other types of diabetes; (2) Symptomatic hypoglycemia requiring medical intervention within 12 months prior to enrollment, or recurrent symptomatic hypoglycemia (>=2 episodes) within the past 6 months; (3) Concomitant gastroparesis or other gastrointestinal motility disorders (e.g., pyloric obstruction, intestinal obstruction); uncontrolled gastroesophageal reflux disease; or other gastrointestinal diseases assessed by the investigator as increasing risk after drug administration (e.g., severe active ulcers, inflammatory bowel disease, acute or chronic symptomatic gastroenteritis, functional gastrointestinal disorders, intestinal tuberculosis); (4) History of chronic cardiac, renal, or hepatic disease (excluding mild fatty liver in healthy subjects and mild-to-moderate fatty liver in overweight/obese subjects); or history of malignancy within the past 5 years (excluding adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, locally cured prostate cancer after radical surgery, or ductal carcinoma in situ of the breast after radical surgery); (5) History of depression or severe psychiatric disorders, including but not limited to suicidal ideation or attempts, schizophrenia, or bipolar disorder; (6) PHQ-9 score >=5 at screening; (7) History of clinically significant or currently apparent diseases/abnormalities (including but not limited to disorders of the nervous, cardiovascular, respiratory, hematologic/lymphatic, immune, renal, hepatic, gastrointestinal, metabolic, or skeletal systems, or neurologic/psychiatric conditions); 5. Any abnormal laboratory findings at screening meeting the following criteria: (1) HbA1c >=6.5%, or fasting glucose >=6.1 mmol/L in healthy subjects, >=7.0 mmol/L in overweight/obese subjects; (2) Hepatic or renal impairment: serum ALT or AST >2× upper limit of normal (ULN), serum total bilirubin >1.5× ULN (if ALT/AST are near but not exceeding 2× ULN and total bilirubin near but not exceeding 1.5× ULN, inclusion must be assessed by the investigator); estimated glomerular filtration rate (eGFR) <60 mL·min^-1·1.73m^
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Plasma Concentration (Cmax);Time to Maximum Plasma Concentration (Tmax);Area Under the Curve (AUC0-t, AUC0-8);Elimination Half-life (t1/2z);Apparent Volume of Distribution (Vz/F) and Apparent Clearance (CL/F);Changes in Body Weight, Waist Circumference, Hip Circumference, and Waist-to-Hip Ratio;Changes in Fasting Blood Glucose and Fasting Lipid Levels;Change in Appetite Visual Analog Scale (VAS) Score;Change in Food Intake;Effect on QT/QTc Interval;Seropositivity Rate and Titer Level of Anti-UBT37034 Antibodies;Seropositivity Rate of Anti-UBT37034 Neutralizing Antibodies; | — |
Countries
China
Contacts
Public ContactYang Guoping
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Outcome results
None listed