A Study of BGM1812 Injection in Healthy and Non-diabetic Overweight or Obese Chinese Participants (NCT07294235) | Clinical Trial Compass
RecruitingPhase 1
A Study of BGM1812 Injection in Healthy and Non-diabetic Overweight or Obese Chinese Participants
China60 participantsStarted 2025-12-05
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 HB…
What they're measuring
1
Number of Participants with One or More Adverse Events (AEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator
Timeframe: Baseline to Study Completion (Up to 6-9weeks)