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

Phase 1

Recruiting

• Conditions: Type 2 Diabetes Mellitus (T2DM); Overweight or Obese
• Interventions: Drug: BGM0504

• Registration Number: NCT06929156
• Lead Sponsor: BrightGene Bio-Medical Technology Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-04-08
• Study First Submitted QC: 2025-04-08
• Last Update Submitted: 2025-04-08
• Study Start: 2025-04-15
• Study First Posted: 2025-04-16
• Last Update Posted: 2025-04-16
• Primary Completion: 2025-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A group (Healthy Control)	BGM0504	-
B group (Mild Renal Impairment)	BGM0504	-
C group (Moderate Renal Impairment)	BGM0504	-
D group (Severe Renal Impairment)	BGM0504	-

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration Versus Time Curve (AUC) of BGM0504 From Time Zero to Tlast (AUC0-t)	Start of Treatment up to Day 29	Area Under the Concentration Versus Time Curve (AUC) of BGM0504 From Time Zero to Tlast (AUC0-t)
Maximum Concentration of BGM0504 (Cmax)	Start of Treatment up to Day 29	Maximum Concentration of BGM0504 (Cmax)
Area Under the Concentration Versus Time Curve (AUC) of BGM0504 From Time Zero to Infinity (AUC0-inf)	Start of Treatment up to Day 29	Area Under the Concentration Versus Time Curve (AUC) of BGM0504 From Time Zero to Infinity (AUC0-inf)

Secondary Outcome Measures

Name	Time	Method
Time to maximum concentration (Tmax)	Start of Treatment up to Day 29	Time to maximum concentration (Tmax)
Apparent terminal half-life (t1/2)	Start of Treatment up to Day 29	Apparent terminal half-life (t1/2)
Apparent clearance (CL/F)	Start of Treatment up to Day 29	Apparent clearance (CL/F)
Incidence and severity of adverse events	Screening period up to Day 29	Incidence and severity of adverse events

Trial Locations

Locations (1)

The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital, Shandong Province); 🇨🇳 Jinan City, Shandong, China