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

Launched by BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO., LTD. · Apr 8, 2025

Keywords

ClinConnect Summary

This clinical trial, called the BGM0504 study, is investigating how a new medication, BGM0504, is processed in the bodies of healthy individuals compared to those with kidney problems. The goal is to understand how quickly the drug enters the bloodstream and how long it stays in the body, especially for participants who have impaired kidney function, which is important for ensuring the safety and effectiveness of the medication in different patient groups.

To participate, individuals need to be between 18 and 65 years old, with a body mass index (BMI) that falls between 19.0 and 30.0 kg/m². They must also have stable kidney function, confirmed through specific tests. However, some people may not be eligible if they have severe allergies, certain medical histories, or if they are currently pregnant or breastfeeding. Participants can expect to undergo health screenings and tests during the trial, and their participation will help researchers gather valuable information about BGM0504, benefiting future patients with type 2 diabetes and kidney issues.

Gender

ALL

Eligibility criteria

• 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.