Obesity & Overweight
Conditions
Brief summary
The purpose of this study is to evaluate the safety and tolerability of subcutaneously administered SGB-7342 in adult subjects with obesity and overweight.
Interventions
Normal saline (0.9% NaCl) in a matching volume, SC injection, single dose
SC injection, single dose
Sponsors
Study design
Eligibility
Inclusion criteria
* Body Mass Index (BMI) within the range of 26.0 to 35.0 kg/m² * Have a stable body weight within 3 months * Participants must agree to use adequate contraception from signing the informed consent until 6 months after completion of the follow-up visit. * Willing to comply with the protocol required visit schedule and visit requirements and provide written informed consent.
Exclusion criteria
* A history of or a current surgical or medical condition that, in the opinion of the Investigator, may put the subject at significant risk (according to Investigator's judgment) or interfere with the subject's participation in the clinical study. * Use of GLP-1R agonists for any indication within 6 months prior to administering the investigational drug. * Use of non-GLP1R medications for weight loss within 3 months prior to administering the investigational drug. * Alanine aminotransferase (ALT), total bilirubin (TBIL), aspartate aminotransferase (AST)\> 1.5 × ULN, and deemed clinically significant by the Investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Events (AEs) | up to approximately 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Observed Plasma Concentration (Cmax) | up to approximately 3 days |
| Area Under the Concentration-time Curve (AUC) | up to 3 days |
| Weight change from baseline | up to approximately 12 months |