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

NCT ID: NCT06929156

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-08
• Study Completion Date: 2025-11-30

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.

Conditions

Type 2 Diabetes Mellitus (T2DM); Overweight or Obese

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A group (Healthy Control)

Group Type: EXPERIMENTAL

BGM0504

Intervention Type: DRUG

Receive a single dose of BGM0504 injection

B group (Mild Renal Impairment)

Group Type: EXPERIMENTAL

BGM0504

Intervention Type: DRUG

Receive a single dose of BGM0504 injection

C group (Moderate Renal Impairment)

Group Type: EXPERIMENTAL

BGM0504

Intervention Type: DRUG

Receive a single dose of BGM0504 injection

D group (Severe Renal Impairment)

Group Type: EXPERIMENTAL

BGM0504

Intervention Type: DRUG

Receive a single dose of BGM0504 injection

Interventions

BGM0504

Receive a single dose of BGM0504 injection

Intervention Type: DRUG

BGM0504

Receive a single dose of BGM0504 injection

Intervention Type: DRUG

BGM0504

Receive a single dose of BGM0504 injection

Intervention Type: DRUG

BGM0504

Receive a single dose of BGM0504 injection

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BrightGene Bio-Medical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital, Shandong Province)

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wei Zhao

Role: CONTACT

Zhao4wei2@hotmail.com

860531-82921552

Facility Contacts

Wei Zhao

Role: primary

Zhao4wei2@hotmail.com

860531-82921552

Other Identifiers

BGM0504-I-101

Identifier Type: -

Identifier Source: org_study_id