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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus (T2DM); Overweight or Obese
• Intervention / Treatment: Drug: BGM0504

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 650100
      • The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital, Shandong Province)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A group (Healthy Control)	Drug: BGM0504; Receive a single dose of BGM0504 injection
Experimental: B group (Mild Renal Impairment)	Drug: BGM0504; Receive a single dose of BGM0504 injection
Experimental: C group (Moderate Renal Impairment)	Drug: BGM0504; Receive a single dose of BGM0504 injection
Experimental: D group (Severe Renal Impairment)	Drug: BGM0504; Receive a single dose of BGM0504 injection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: BrightGene Bio-Medical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2025
• Primary Completion (Actual): December 25, 2025
• Study Completion (Actual): December 25, 2025

Study Registration Dates

• First Submitted: April 8, 2025
• First Submitted That Met QC Criteria: April 8, 2025
• First Posted (Actual): April 16, 2025

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Diabetes Mellitus, Type 2
• Other Study ID Numbers: BGM0504-I-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No