Type 2 Diabetes Mellitus (T2DM)Phase 1NCT06929156
A Study of BGM0504 in Healthy Participants and Participants With Impaired Renal Function
A Phase 1 study testing BGM0504 in people with Type 2 Diabetes Mellitus (T2DM) and Overweight or Obese, run by BrightGene Bio-Medical Technology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Overweight or Obese
- What is being tested?
- BGM0504
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2025to 25 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- √ 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):
- Normal renal function: 90-129 mL/min (inclusive);
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- Mild impairment: 60-89 mL/min (inclusive);
- Moderate impairment: 30-59 mL/min (inclusive);
- Severe impairment: 15-29 mL/min (inclusive);
Who cannot join
- ● 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital, Shandong Province)
Jinan, Shandong, 650100
About this study
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
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.
- Being tested
- BGM0504
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGM0504Drug
Receive a single dose of BGM0504 injection
BGM0504Drug
Receive a single dose of BGM0504 injection
BGM0504Drug
Receive a single dose of BGM0504 injection
BGM0504Drug
Receive a single dose of BGM0504 injection
| Study group | Role | What they receive |
|---|---|---|
| A group (Healthy Control) | Experimental | Not described Receives: Drug: BGM0504 |
| B group (Mild Renal Impairment) | Experimental | Not described Receives: Drug: BGM0504 |
| C group (Moderate Renal Impairment) | Experimental | Not described Receives: Drug: BGM0504 |
| D group (Severe Renal Impairment) | Experimental | Not described Receives: Drug: BGM0504 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Start of Treatment up to Day 29
Maximum Concentration of BGM0504 (Cmax)
Maximum Concentration of BGM0504 (Cmax)
Measured: 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)
Measured: Start of Treatment up to Day 29
Secondary outcomes (4)
Time to maximum concentration (Tmax)
Time to maximum concentration (Tmax)
Measured: Start of Treatment up to Day 29
Apparent terminal half-life (t1/2)
Apparent terminal half-life (t1/2)
Measured: Start of Treatment up to Day 29
Apparent clearance (CL/F)
Apparent clearance (CL/F)
Measured: Start of Treatment up to Day 29
Incidence and severity of adverse events
Incidence and severity of adverse events
Measured: Screening period up to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start6 May 2025
- Primary completion25 Dec 2025
- Study completion25 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- BrightGene Bio-Medical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929156
- Sponsor's protocol ID
- BGM0504-I-101
- Status last verified
- Feb 2025
- First submitted
- 8 Apr 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06929156
- Acronym / sponsor ID
- BGM0504-I-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- BrightGene Bio-Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 May 2025 (actual)
- Primary completion
- 25 Dec 2025 (actual)
- Study completion
- 25 Dec 2025 (actual)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A group (Healthy Control) | Experimental | Drug: BGM0504 |
| B group (Mild Renal Impairment) | Experimental | Drug: BGM0504 |
| C group (Moderate Renal Impairment) | Experimental | Drug: BGM0504 |
| D group (Severe Renal Impairment) | Experimental | Drug: BGM0504 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- √ Age 18-65 years on the date of signing informed consent (inclusive);
Key exclusion criteria (8 listed)
- ● Allergic constitution includes severe drug allergy or history of drug allergy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BGM0504Receive a single dose of BGM0504 injection | Drug | A group (Healthy Control) |
| BGM0504Receive a single dose of BGM0504 injection | Drug | B group (Mild Renal Impairment) |
| BGM0504Receive a single dose of BGM0504 injection | Drug | C group (Moderate Renal Impairment) |
| BGM0504Receive a single dose of BGM0504 injection | Drug | D group (Severe Renal Impairment) |
Primary outcome
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
Area Under the Concentration Versus Time Curve (AUC) of BGM0504 From Time Zero to Tlast (AUC0-t)
Maximum Concentration of BGM0504 (Cmax)
Time frame: 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)
Time frame: Start of Treatment up to Day 29
Area Under the Concentration Versus Time Curve (AUC) of BGM0504 From Time Zero to Infinity (AUC0-inf)
4 secondary outcomes
Time to maximum concentration (Tmax)
Time frame: Start of Treatment up to Day 29
Apparent terminal half-life (t1/2)
Time frame: Start of Treatment up to Day 29
Apparent clearance (CL/F)
Time frame: Start of Treatment up to Day 29
Incidence and severity of adverse events
Time frame: Screening period up to Day 29
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BGM0504 in people with Type 2 Diabetes Mellitus (T2DM) and Overweight or Obese, run by BrightGene Bio-Medical Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.