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NCT Number: NCT07294235

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Yunnan University of Chinese Medicine

Kunming, Yunnan, 650000, China

Location status: Recruiting

Location contact

Jianchang He

CONTACT

[email protected]

13700680697

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BGM1812

Drug

AdministeredSC

Placebo

Drug

Administered SC

Primary outcomes

  1. Number of Participants with One or More Adverse Events (AEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator

    Time frame: 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 outcomes

  1. Pharmacokinetic (PK): Maximum Concentration (Cmax) of BGM1812

    Time frame: Baseline to Study Completion (Up to 6-9weeks)

    PK Cmax of BGM1812

  2. PK: Area Under the Concentration Versus Time Curve (AUC) of BGM1812

    Time frame: Baseline to Study Completion (Up to 6-9weeks)

    PK:AUC of BGM1812

  3. Pharmacodynamics (PD): Fasting Blood Glucose of BGM1812

    Time frame: 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

  4. PD:C-Peptide of BGM1812

    Time frame: 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

  5. PD: Insulin of BGM1812

    Time frame: 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

  6. PD: Body Weight of BGM1812

    Time frame: 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

  7. PD: Waist Circumference of BGM1812

    Time frame: 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

  8. Immunogenicity Endpoints

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

BrightGene Bio-Medical Technology Co., Ltd.

Industry

Collaborators

  • BrightGene Pharmaceutical Co., Ltd.

Registry information

Official study title

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single/Multiple-dose Study to Evaluate the Tolerability, Safety and Pharmacokinetics of BGM1812 in Healthy and Non-diabetic Overweight or Obese Chinese Participants

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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