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A Study of BGM0504 in Healthy Participants and Participants With Impaired Renal Function

A Study of BGM0504 in Healthy Participants and Participants With Impaired Renal Function

Recruiting
18-65 years
All
Phase 1

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Overview

The purpose of this study is to assess how fast BGM0504 gets into the blood stream and how long it takes the body to remove it in participants with impaired kidney function compared to healthy participants.

Eligibility

Inclusion Criteria:

  • √ Age 18-65 years on the date of signing informed consent (inclusive);
    • Body mass index (BMI) within the range of 19.0-30.0 kg/m2 (inclusive);.
    • Stable renal function, assessed by two eGFR during screening (apart at least 3 days);
    • Diagnosed as stable, chronic renal disease for at least 3 months.
    • Renal function, assessed by estimated glomerular filtration rate at screening (eGFR):
      1. Normal renal function: 90-129 mL/min (inclusive);
      2. Mild impairment: 60-89 mL/min (inclusive);
      3. Moderate impairment: 30-59 mL/min (inclusive);
      4. Severe impairment: 15-29 mL/min (inclusive);

Exclusion Criteria:

  • ● Allergic constitution includes severe drug allergy or history of drug allergy;
    • Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2; Have a history or presence of pancreatitis;
    • Participants in clinical trials of any drug or medical device in the 3 months prior to screening;.
    • Suspected or confirmed history of alcohol or drug abuse;
    • Hepatitis B surface antigen (HBsAg), HIV antibody detection, hepatitis C virus antibody (HCVAb), treponema pallidum specific antibody detection, positive;
    • Donation or loss of 200 mL or more of blood within 3 months prior to screening, or blood donation during screening or within 1 months after the end of the trial;
    • Pregnant or Breast-feeding women;
    • The investigator considers that the participant has any other factors that would make it inappropriate to participate in this study.

Study details
    Type 2 Diabetes Mellitus (T2DM)
    Overweight or Obese

NCT06929156

BrightGene Bio-Medical Technology Co., Ltd.

24 July 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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