Overweight or Obesity
Conditions
Brief summary
The purpose of this study is to evaluate the tolerability , safety and pharmacodynamics of BGM1812 administered subcutaneously in healthy and non-diabetic overweight or obese Chinese participants, and to investigate the pharmacokinetic profile of BGM1812 in the bloodstream.
Interventions
DRUGBGM1812
AdministeredSC
DRUGPlacebo
Administered SC
Sponsors
BrightGene Pharmaceutical Co., Ltd.
BrightGene Bio-Medical Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Between the ages of 18 and 65 years (inclusive) at the time of screening , healthy and non-diabetic overweight or obese subjects , both male and female; * Healthy subjects , male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 20.0 kg/m² ≤ BMI \< 24 kg/m²（BMI = weight/height²）; * Obese individuals: BMI ≥ 28.0 kg/m², or overweight individuals: 24.0 kg/m² ≤ BMI \< 28.0 kg/m²; * (Medical Inquiry) Have a stable body weight (\<5% self-reported change during the previous 12 weeks) before screening. * Have no history of mental disorders, be able to communicate smoothly with Investigator, Capable of understanding the written informed consent document; willingly provides valid, signed written informed consent; willing and able to comply with the schedule, requirements and restrictions of the study. * Male subjects with female partners of reproductive potential must agree to practice abstinence or to use a condom (male subject) plus an additional medically acceptable form of contraception (female partner) for the duration of the study and for at least 3 months after dosing; must also agree to refrain from sperm donation for at least 3 months post dose.
Exclusion criteria
* Those with a history of severe drug allergies (especially those with known or suspected allergies to related compounds of BGM1812), or complicated with severe specific allergic diseases/history, or with a severe allergic constitution. * Subjects with positive results for HBsAg, anti-HCV, anti-HIV or anti-TP during the screening period. * 12-lead ECG shows ventricular heart rate \< 50 beats/min or \> 100 beats/min at screening/baseline, second or third degree atrioventricular block, long QT syndrome, QTcF\> 470ms for women or \> 450ms for men, pre-excitation syndrome or other significant arrhythmias. * Used illegal drugs within 6 months prior to screening, or substance abuse within 12 months prior to screening. * Participated in drug or medical device clinical trials and treated with Study Drug (excluding placebo) or medical device intervention within 12 weeks before screening. * Participants who have received any vaccine within 2 weeks prior to screening, or plan to receive a vaccine during the trial. * Female participants who are pregnant or lactating, or those with a positive pregnancy test result during the screening period. * Positive urine drug test or alcohol serum test result at screening or at baseline. * Has any other conditions or disorders deemed unsuitable for including in the study, in the opinion of the Investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with One or More Adverse Events (AEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator | Baseline to Study Completion (Up to 6-9weeks) | Number of participants with AEs and SAEs will be assessed with reference to CTCAE V5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK: Area Under the Concentration Versus Time Curve (AUC) of BGM1812 | Baseline to Study Completion (Up to 6-9weeks) | PK:AUC of BGM1812 |
| Pharmacodynamics (PD): Fasting Blood Glucose of BGM1812 | Baseline to Study Completion (Up to 6-9weeks) | PD: Changes in fasting blood glucosebefore and after administration, and differences in the amount of change among different dose groups |
| PD:C-Peptide of BGM1812 | Baseline to Study Completion (Up to 6-9weeks) | PD: Changes in C-peptide before and after administration, and differences in the amount of change among different dose groups |
| Pharmacokinetic (PK): Maximum Concentration (Cmax) of BGM1812 | Baseline to Study Completion (Up to 6-9weeks) | PK Cmax of BGM1812 |
| PD: Body Weight of BGM1812 | Baseline to Study Completion (Up to 6-9weeks) | PD: Changes in body weight before and after administration, and differences in the amount of change among different dose groupsPD: Changes in body weight before and after administration, and differences in the amount of change among different dose groups |
| PD: Waist Circumference of BGM1812 | Baseline to Study Completion (Up to 6-9weeks) | PD: Changes in waist circumference before and after administration, and differences in the amount of change among different dose groups |
| Immunogenicity Endpoints | Baseline to Study Completion (Up to 6-9weeks) | Detect the anti-drug antibodies (ADA) of the study drug and their titers; if the ADA is positive, neutralizing antibodies (NAb) will be further detected. |
| PD: Insulin of BGM1812 | Baseline to Study Completion (Up to 6-9weeks) | PD: Changes in insulin before and after administration, and differences in the amount of change among different dose groups |
Countries
China
Outcome results
None listed