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

NCT07294235 — Phase 1, Completed, 60 participants, BrightGene Bio-Medical Technology Co., Ltd.

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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

RegistryNCT07294235
StatusCompleted
PhasePhase 1
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment60 (Actual)
SponsorBrightGene Bio-Medical Technology Co., Ltd. (Industry)
ConditionsOverweight or Obesity
InterventionsBGM1812, Placebo (Drug)
Datesstart 2025-12-05, primary completion 2026-06-05, completion 2026-06-05, first posted 2025-12-19, last updated 2026-10-15
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Overweight or Obesity All trials of BGM1812 All trials of Placebo

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
BGM1812(Part A)ExperimentalDrug: BGM1812Single ascending doses of BGM1812 administered subcutaneously (SC)
Placebo (Part A)Placebo comparatorDrug: PlaceboPlacebo administered SC
BGM1812 (Part B)ExperimentalDrug: BGM1812Multiple ascending doses of BGM1812 administered SC.
Placebo (Part B)Placebo comparatorDrug: PlaceboPlacebo administered SC.
  • BGM1812 (Drug): AdministeredSC
  • Placebo (Drug): Administered SC
  • BGM1812 (Drug): Administered SC
  • Placebo (Drug): Administered SC

+Outcome measures

Primary outcomes

  • 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 outcomes

  • Pharmacokinetic (PK): Maximum Concentration (Cmax) of BGM1812 [Baseline to Study Completion (Up to 6-9weeks)]: PK Cmax of BGM1812
  • 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
  • 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
  • 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
  • Anti-drug antibodies (ADA) of the study drug and their titers [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.

+Eligibility

Sex: All, ages: 18 Years to 55 Years, accepts healthy volunteers

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.

+Locations (1)

FacilityCityCountryStatus
The First Affiliated Hospital of Yunnan University of Chinese MedicineKunming, YunnanChina