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

NCT07294235 | Recruiting Phase 1 FDA Drug

• 1 other identifier: BGM1812-CPK-101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight or Obesity

Outcome Measures

Primary Outcomes (1)

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

  Number of participants with AEs and SAEs will be assessed with reference to CTCAE V5.0

  Baseline to Study Completion (Up to 6-9weeks)

Secondary Outcomes (8)

• Pharmacokinetic (PK): Maximum Concentration (Cmax) of BGM1812

  Baseline to Study Completion (Up to 6-9weeks)

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

  Baseline to Study Completion (Up to 6-9weeks)

• Pharmacodynamics (PD): Fasting Blood Glucose of BGM1812

  Baseline to Study Completion (Up to 6-9weeks)

• PD:C-Peptide of BGM1812

  Baseline to Study Completion (Up to 6-9weeks)

• PD: Insulin of BGM1812

  Baseline to Study Completion (Up to 6-9weeks)

Study Arms (4)

BGM1812(Part A)

EXPERIMENTAL

Single ascending doses of BGM1812 administered subcutaneously (SC)

Drug: BGM1812

Placebo (Part A)

PLACEBO COMPARATOR

Placebo administered SC

Drug: Placebo

BGM1812 (Part B)

EXPERIMENTAL

Multiple ascending doses of BGM1812 administered SC.

Drug: BGM1812

Placebo (Part B)

PLACEBO COMPARATOR

Placebo administered SC.

Drug: Placebo

Interventions

Placebo DRUG

Administered SC

Placebo (Part A)

BGM1812 DRUG

AdministeredSC

BGM1812(Part A)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• BrightGene Pharmaceutical Co., Ltd.: collaborator
• BrightGene Bio-Medical Technology Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Yunnan University of Chinese Medicine

Kunming, Yunnan, 650000, China

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: December 19, 2025
• Study Start: December 5, 2025
• Primary Completion: March 2, 2026
• Study Completion: March 2, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-11

Locations

CN (1)