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

BrightGene Bio-Medical Technology Co., Ltd.

Status and phase: Enrolling; Phase 1

Conditions: Type 2 Diabetes Mellitus (T2DM); Overweight or Obese

Treatments: Drug: BGM0504

Study type: Interventional

Funder types: Industry

Identifiers

NCT06929156

BGM0504-I-101

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

A group (Healthy Control)

Experimental group

Treatment:

Drug: BGM0504

Drug: BGM0504

Drug: BGM0504

Drug: BGM0504

B group (Mild Renal Impairment)

Experimental group

Treatment:

Drug: BGM0504

Drug: BGM0504

Drug: BGM0504

Drug: BGM0504

C group (Moderate Renal Impairment)

Experimental group

Treatment:

Drug: BGM0504

Drug: BGM0504

Drug: BGM0504

Drug: BGM0504

D group (Severe Renal Impairment)

Experimental group

Treatment:

Drug: BGM0504

Drug: BGM0504

Drug: BGM0504

Drug: BGM0504