Status:
RECRUITING
A Study of BGM0504 in Healthy Participants and Participants With Impaired Renal Function
Lead Sponsor:
BrightGene Bio-Medical Technology Co., Ltd.
Conditions:
Type 2 Diabetes Mellitus (T2DM)
Overweight or Obese
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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 partici...
Eligibility Criteria
Inclusion
- √ 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):
- Normal renal function: 90-129 mL/min (inclusive);
- Mild impairment: 60-89 mL/min (inclusive);
- Moderate impairment: 30-59 mL/min (inclusive);
- Severe impairment: 15-29 mL/min (inclusive);
Exclusion
- ● 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.
Key Trial Info
Start Date :
May 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2025
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06929156
Start Date
May 8 2025
End Date
November 30 2025
Last Update
July 16 2025
Active Locations (1)
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1
The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital, Shandong Province)
Jinan, Shandong, China, 650100