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A Study of BGM1812 Injection in Healthy and Non-diabetic Overweight or Obese Chinese Participants

A Study of BGM1812 Injection in Healthy and Non-diabetic Overweight or Obese Chinese Participants

Recruiting
18-55 years
All
Phase 1

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Overview

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.

Eligibility

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.

Study details
    Overweight or Obesity

NCT07294235

BrightGene Bio-Medical Technology Co., Ltd.

1 February 2026

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