Clinical trial NCT06929156: A Study of BGM0504 in Healthy Participants and Participants With Impaired Renal Function
Official title: A Multi-center, Single-dose, Open-label, Parallel Design, Pharmacokinetics Study of BGM0504 Injection in Healthy Participants and Participants With Impaired Renal Function
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus (T2DM)
Overweight or Obese
Lead sponsor: BrightGene Bio-Medical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-04-16
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 participants.


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.

Primary outcomes:
measure: Area Under the Concentration Versus Time Curve (AUC) of BGM0504 From Time Zero to Tlast (AUC0-t)
timeFrame: Start of Treatment up to Day 29
measure: Maximum Concentration of BGM0504 (Cmax)
timeFrame: Start of Treatment up to Day 29
measure: Area Under the Concentration Versus Time Curve (AUC) of BGM0504 From Time Zero to Infinity (AUC0-inf)
timeFrame: Start of Treatment up to Day 29
Secondary outcomes:
measure: Time to maximum concentration (Tmax)
timeFrame: Start of Treatment up to Day 29
measure: Apparent terminal half-life (t1/2)
timeFrame: Start of Treatment up to Day 29
measure: Apparent clearance (CL/F)
timeFrame: Start of Treatment up to Day 29
measure: Incidence and severity of adverse events
timeFrame: Screening period up to Day 29
Other outcomes:
Locations:
city: Jinan City
country: China
facility: The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital, Shandong Province)
state: Shandong
Study officials:
References: