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Recruiting NCT07294235

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

Phase I Interventional Overweight or Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BGM1812, Placebo, BGM1812, Placebo.
Who it may be relevant to
Registry conditions: Overweight or Obesity. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Drug BGM1812
    AdministeredSC
  • Drug Placebo
    Administered SC
  • Drug BGM1812
    Administered SC
  • Drug Placebo
    Administered SC

Primary outcome measures

  • 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)]
Secondary outcome measures (8)
  • Pharmacokinetic (PK): Maximum Concentration (Cmax) of BGM1812 [Time frame: Baseline to Study Completion (Up to 6-9weeks)]
  • PK: Area Under the Concentration Versus Time Curve (AUC) of BGM1812 [Time frame: Baseline to Study Completion (Up to 6-9weeks)]
  • Pharmacodynamics (PD): Fasting Blood Glucose of BGM1812 [Time frame: Baseline to Study Completion (Up to 6-9weeks)]
  • PD:C-Peptide of BGM1812 [Time frame: Baseline to Study Completion (Up to 6-9weeks)]
  • PD: Insulin of BGM1812 [Time frame: Baseline to Study Completion (Up to 6-9weeks)]
  • PD: Body Weight of BGM1812 [Time frame: Baseline to Study Completion (Up to 6-9weeks)]
  • PD: Waist Circumference of BGM1812 [Time frame: Baseline to Study Completion (Up to 6-9weeks)]
  • Immunogenicity Endpoints [Time frame: Baseline to Study Completion (Up to 6-9weeks)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of Yunnan University of Chinese Medicine — Kunming

Identifiers

NCT: NCT07294235 · BGM1812-CPK-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗