Weight Management, Type 2 Diabetes Mellitus, and Non-Alcoholic Fatty Liver Disease
Conditions
Interventions
0.1mg:0.1mg UBT251 injection is injected subcutaneously in the abdomen
0.3mg:0.3mg UBT251 injection is injected subcutaneously in the abdomen
1mg:Subcutaneous injection of UBT251 Injection 1mg or placebo in the abdomen
3mg:Subcutaneous injection of UBT251 Injection 3mg or placebo in the abdomen
8mg:Subcutaneous injection of UBT251 Injection 8mg or placebo in the abdomen
4.5mg:Subcutaneous injection of UBT251 Injection 4.5mg or placebo in the abdomen
6mg:Subcutaneous injection of UBT251 Injection 6mg or placebo in the abdomen
Sponsors
The Third Xiangya Hospital Central South University
Eligibility
Sex/Gender
All
Age
20 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 20–65 years (inclusive), male or female; 2. BMI (weight/height^2, kg/m^2): 19.0–35.0 (inclusive); screening weight: male >60kg, female >50kg; 3. Stable body weight for 3 months prior to randomization (weight change < 5%); 4. No dietary adjustments or nutrition/lifestyle-altering measures in 3 months prior to randomization; 5. Subjects (including partners) agree to use appropriate and effective contraception (non-contraceptive pills) voluntarily from screening to 6 months after study drug administration; no plan to donate sperm or eggs within 6 months after study drug administration; 6. Able to communicate well with investigators, fully understand the study, voluntarily participate, comply with all study requirements, and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to the study drug, its excipients, or other GLP-1 receptor agonists; history of clinically significant multiple or severe drug allergies; current allergic disease; or atopic diathesis; 2. Use of GLP-1 receptor agonists (GLP-1R), GLP-1R/GCGR agonists, GLP-1R/GIP agonists, or GLP-1R/GIPR/GCGR agonists within 3 months prior to screening; 3. Use of any over-the-counter drugs, prescription drugs, and/or nutritional supplements within 14 days prior to study drug administration; or planned use of the following during the study: (1) Drugs that reduce gastrointestinal motility, including but not limited to anticholinergics, antispasmodics, 5-hydroxytryptamine-3 receptor antagonists, dopamine antagonists, and opiates; (2) Cold medicines containing pseudoephedrine; (3) Drugs known to prolong the QT/QTc interval; (4) Vaccination with live attenuated vaccines or COVID-19 vaccines within 1 month prior to screening, or planned vaccination during the study; (5) Other substances that may affect study evaluation; 4. History or evidence of any of the following diseases: (1) Diagnosis of type 1 or type 2 diabetes mellitus; (2) Personal history or family history (among first-degree relatives, i.e., parents, children, or siblings) of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2); (3) Acute pancreatitis within 6 months prior to screening, or past history of chronic pancreatitis or pancreatic surgery; (4) Clinical signs or symptoms of significant liver disease, acute or chronic hepatitis; (5) Comorbid gastroparesis or other diseases related to gastrointestinal emptying disorders (e.g., pyloric obstruction, intestinal obstruction, etc.), uncontrolled gastroesophageal reflux disease, or gastrointestinal diseases assessed by investigators as increasing post-administration risks (e.g., severe active ulcers, inflammatory bowel disease, gastroesophageal reflux disease, acute gastroenteritis, symptomatic chronic gastroenteritis, functional gastrointestinal disorders, intestinal tuberculosis, etc.); (6) History of malignant tumors within 5 years prior to screening (excluding fully treated carcinoma in situ of the cervix, basal cell or squamous cell skin carcinoma, localized prostate cancer after radical resection, and ductal carcinoma in situ of the breast after radical resection); (7) Past history of clinically severe diseases/abnormalities or current clinically significant diseases/abnormalities (including but not limited to diseases of the nervous, cardiovascular, respiratory, hematological and lymphatic, immune, renal, hepatic, gastrointestinal, metabolic, and skeletal systems, as well as a history of malignant tumors, and neurological or psychiatric diseases/abnormalities); 5. Any abnormal examination findings at screening meeting the following criteria: (1) HbA1c >= 6.5%; (2) Hepatic or renal impairment: serum ALT/AST > 2×upper limit of normal (ULN) per hospital laboratory reference; total bilirubin > 1.5×ULN; estimated glomerular filtration rate (eGFR) = 15pg/mL (i.e., 15ng/L); (4) Serum amylase or lipase > upper limit of normal (ULN); (5) Fasting triglycerides >= 5.0mmol/L; (6) Severe electrocardiogram (ECG) abnormalities, defined as: 1) Second- or third-degree atrioventricular block; 2) Long QT syndrome or QTcF > 450ms (calculation formula see Appendix 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital signs;Electrocardiogram data;Injection site examination; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic;Immunogenicity;Pharmacodynamics; | — |
Countries
China
Contacts
Public ContactGuoping Yang
The Third Xiangya Hospital Central South University
Outcome results
None listed