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CompletedNCT06929156Updated Feb 11, 2026

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

A Phase 1 interventional study of BGM0504 and BGM0504 in Type 2 Diabetes Mellitus (T2DM) and Overweight or Obese, sponsored by BrightGene Bio-Medical Technology Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-11.

Sponsored by BrightGene Bio-Medical Technology Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
34
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus (T2DM)
  • Overweight or Obese
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 34 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

BrightGene Bio-Medical Technology Co., Ltd. is the lead sponsor of 17 studies on the registry; 12 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    A group (Healthy Control)

    Drug: BGM0504

  • Experimental
    B group (Mild Renal Impairment)

    Drug: BGM0504

  • Experimental
    C group (Moderate Renal Impairment)

    Drug: BGM0504

  • Experimental
    D group (Severe Renal Impairment)

    Drug: BGM0504

Interventions

  • DrugBGM0504

    Receive a single dose of BGM0504 injection

  • DrugBGM0504

    Receive a single dose of BGM0504 injection

  • DrugBGM0504

    Receive a single dose of BGM0504 injection

  • DrugBGM0504

    Receive a single dose of BGM0504 injection

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Start of Treatment up to Day 29

  2. Maximum Concentration of BGM0504 (Cmax)

    Maximum Concentration of BGM0504 (Cmax)

    Time frame: Start of Treatment up to Day 29

  3. 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)

    Time frame: Start of Treatment up to Day 29

Secondary outcomes

  1. Time to maximum concentration (Tmax)

    Time to maximum concentration (Tmax)

    Time frame: Start of Treatment up to Day 29

  2. Apparent terminal half-life (t1/2)

    Apparent terminal half-life (t1/2)

    Time frame: Start of Treatment up to Day 29

  3. Apparent clearance (CL/F)

    Apparent clearance (CL/F)

    Time frame: Start of Treatment up to Day 29

  4. Incidence and severity of adverse events

    Incidence and severity of adverse events

    Time frame: Screening period up to Day 29

07

Study locations

1 site
  • The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital, Shandong Province)
    Jinan, Shandong 650100, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06929156
Lead sponsor
BrightGene Bio-Medical Technology Co., Ltd.
Responsible party
Sponsor
First posted
Apr 16, 2025
Start date
May 6, 2025
Primary completion
Dec 25, 2025
Completion
Dec 25, 2025
Last update
Feb 11, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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