BGM1812 injections for healthy non‑diabetic Chinese adults who are overweight or obese

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

This test will see if subcutaneous BGM1812 is safe, well tolerated, and how it behaves in the body of healthy, non‑diabetic Chinese adults who are overweight or obese.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: BrightGene Bio-Medical Technology Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Kunming, Yunnan)
• Trial ID: NCT07294235 on ClinicalTrials.gov

What this trial studies

This Phase 1, single‑center trial gives subcutaneous injections of BGM1812 or placebo to healthy, non‑diabetic Chinese adults who are overweight or obese to characterize tolerability, safety, pharmacodynamics, and pharmacokinetics. Participants will have scheduled blood sampling to measure drug levels and biomarker responses over time. Safety monitoring will include adverse event tracking, clinical labs, and vital signs. The trial is sponsored by BrightGene and conducted at The First Affiliated Hospital of Yunnan University of Chinese Medicine in Kunming.

Who should consider this trial

Good fit: Adults 18–65 years who are healthy, non‑diabetic, have BMI in the overweight (24.0–<28.0 kg/m²) or obese (≥28.0 kg/m²) range, stable body weight, and can attend the Kunming clinic and provide informed consent.

Not a fit: People with diabetes, significant medical or psychiatric conditions, pregnant or breastfeeding women, those outside the specified age or BMI ranges, or those unable to travel to the Kunming site are unlikely to receive benefit from participation.

Why it matters

Potential benefit: If successful, BGM1812 could become a well‑tolerated injectable option that favorably affects metabolic pathways related to overweight and obesity.

How similar studies have performed: Early human studies of other injectable biologics that target weight or metabolic pathways have shown promising safety and PK signals, but BGM1812 itself is a novel investigational agent without published efficacy results yet.

Eligibility criteria

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.

Where this trial is running

Kunming, Yunnan

• The First Affiliated Hospital of Yunnan University of Chinese Medicine — Kunming, Yunnan, China (Recruiting)

Conditions Overweight or Obesity