Assessing BGM0504 in healthy individuals and those with kidney issues

A Multi-center, Single-dose, Open-label, Parallel Design, Pharmacokinetics Study of BGM0504 Injection in Healthy Participants and Participants With Impaired Renal Function

This study is testing how a new drug called BGM0504 moves through the body in healthy people and those with kidney problems to see if there are any differences.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: BrightGene Bio-Medical Technology Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Jinan City, Shandong)
• Trial ID: NCT06929156 on ClinicalTrials.gov

What this trial studies

This study evaluates the pharmacokinetics of BGM0504, focusing on how quickly it enters the bloodstream and how efficiently the body eliminates it. Participants include both healthy individuals and those with varying degrees of impaired renal function. The study aims to compare these two groups to understand the drug's behavior in different renal conditions. The research is interventional and is classified as Phase 1, indicating an early stage of clinical evaluation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with a BMI between 19.0-30.0 kg/m2 and stable renal function.

Not a fit: Patients with severe drug allergies, a history of medullary thyroid carcinoma, or those currently participating in other clinical trials may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the safe use of BGM0504 for patients with renal impairment, potentially improving treatment options for Type 2 Diabetes Mellitus.

How similar studies have performed: While this specific approach is novel, similar pharmacokinetic studies have shown success in understanding drug behavior in patients with renal impairment.

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.

Where this trial is running

Jinan City, Shandong

• The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital, Shandong Province) — Jinan City, Shandong, China (Recruiting)

Study contacts

• Study coordinator: Wei Zhao

Conditions Type 2 Diabetes Mellitus; Overweight or Obese