Overweight/ObesityPhase 1NCT07382908
Bioequivalence Study of BGM0504 Injection
A Phase 1 study testing BGM0504 Injection multi-dose pen and BGM0504 Injection single-dose pen in people with Overweight/Obesity, run by BrightGene Bio-Medical Technology Co., Ltd. at 1 site in China.
Trial summary
This is a study to evaluate the bioequivalence of a single subcutaneous injection of BGM0504 multi-dose pen (experimental formula T1) and BGM0504 single-dose pen (experimental formula T2) with BGM0504 single-dose pen (reference formula R). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Overweight/Obesity
- What is being tested?
- BGM0504 Injection multi-dose pen and BGM0504 Injection single-dose pen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 29 Dec 2025to 9 Apr 2026
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-55 years (inclusive).
- Male weight ≥50 kg, female weight ≥45 kg, and overweight (24.0 ≤ BMI < 28.0 kg/m²) or obese (BMI ≥ 28.0 kg/m²).
- From signing the ICF until 3 months after dosing, no pregnancy plan and willing to use effective contraception to avoid pregnancy or causing partner pregnancy, and no plan for sperm/egg donation.
- The participant fully understands the trial purpose, nature, methods, and potential adverse reactions, can complete the trial according to the protocol, has good living habits, can maintain good communication with the investigator, and voluntarily signs the ICF.
Who cannot join
- History of severe allergies or severe specific allergic diseases/history (asthma, urticaria, eczematous dermatitis, etc.) or allergic constitution (allergic to two or more foods or drugs), known or suspected allergy to any excipient of BGM0504 Injection.
- Previous diagnosis of type 1 or type 2 diabetes, or clinically significant abnormal HbA1c at screening.
- Family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 syndrome.
- History of acute/chronic pancreatitis, pancreatic injury, or other high-risk factors for pancreatitis.
- Past or screening findings of digestive system diseases that may increase participant risk.
- Positive for HBsAg, HCV antibody, syphilis antibody, or HIV antibody at screening.
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- Participation in any drug or medical device clinical trial and receiving investigational product/device intervention within 3 months prior to screening.
- Consumption or plan to consume specific foods (including pitaya, mango, grapefruit, pomelo or their juices, high-purine foods like animal organs, seafood, chocolate) or beverages containing caffeine/alcohol within 48 hours before dosing; or unwilling to stop consuming these during the in-house period.
- Pregnant or breastfeeding women, or positive pregnancy test at screening.
- Any other condition considered by the investigator as unsuitable for participation or participant withdrawal due to personal reasons..
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Single-Dose, Randomized, Open-Label, Single-Period, Parallel Bioequivalence Study of BGM0504 Injection in Overweight/Obese Participants
This is a study to evaluate the bioequivalence of a single subcutaneous injection of BGM0504 multi-dose pen (experimental formula T1) and BGM0504 single-dose pen (experimental formula T2) with BGM0504 single-dose pen (reference formula R).
- Conditions
- Overweight/Obesity
- Being tested
- BGM0504 Injection multi-dose pen, BGM0504 Injection single-dose pen
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGM0504 Injection multi-dose penDrug
5 mg, single subcutaneous injection in the abdominal region
BGM0504 Injection single-dose penDrug
5 mg, single subcutaneous injection in the abdominal region
BGM0504 Injection single-dose penDrug
5 mg, single subcutaneous injection in the abdominal region
| Study group | Role | What they receive |
|---|---|---|
| BGM0504 Injection multi-dose pen | Experimental | Not described Receives: Drug: BGM0504 Injection multi-dose pen |
| BGM0504 Injection single-dose pen | Experimental | Not described Receives: Drug: BGM0504 Injection single-dose pen |
| BGM0504 Injection single-dose pen-2 | Active comparator | Not described Receives: Drug: BGM0504 Injection single-dose pen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
Peak Plasma Concentration (Cmax)
Measured: 0 to 672 hours
Area under the plasma concentration versus time curve (AUC)0-t
Area under the plasma concentration versus time curve (AUC)0-t
Measured: 0 to 672 hours
Secondary outcomes (1)
Monitor all the adverse event
Monitor all the adverse event was assessed by the investigator.
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start29 Dec 2025
- Primary completion9 Apr 2026
- Study completion9 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight/ObesityStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 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
- NCT07382908
- Sponsor's protocol ID
- BGM0504-BE
- Status last verified
- Oct 2026
- First submitted
- 26 Jan 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Single-Dose, Randomized, Open-Label, Single-Period, Parallel Bioequivalence Study of BGM0504 Injection in Overweight/Obese Participants
- ClinicalTrials.gov ID
- NCT07382908
- Acronym / sponsor ID
- BGM0504-BE
- Conditions
- Overweight/Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- BrightGene Bio-Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Dec 2025 (actual)
- Primary completion
- 9 Apr 2026 (actual)
- Study completion
- 9 Apr 2026 (actual)
- First posted
- 3 Feb 2026 (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.
This is a study to evaluate the bioequivalence of a single subcutaneous injection of BGM0504 multi-dose pen (experimental formula T1) and BGM0504 single-dose pen (experimental formula T2) with BGM0504 single-dose pen (reference formula R).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BGM0504 Injection multi-dose pen | Experimental | Drug: BGM0504 Injection multi-dose pen |
| BGM0504 Injection single-dose pen | Experimental | Drug: BGM0504 Injection single-dose pen |
| BGM0504 Injection single-dose pen-2 | Active comparator | Drug: BGM0504 Injection single-dose pen |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-55 years (inclusive).
- Male weight ≥50 kg, female weight ≥45 kg, and overweight (24.0 ≤ BMI < 28.0 kg/m²) or obese (BMI ≥ 28.0 kg/m²).
- From signing the ICF until 3 months after dosing, no pregnancy plan and willing to use effective contraception to avoid pregnancy or causing partner pregnancy, and no plan for sperm/egg donation.
- The participant fully understands the trial purpose, nature, methods, and potential adverse reactions, can complete the trial according to the protocol, has good living habits, can maintain good communication with the investigator, and voluntarily signs the ICF.
Key exclusion criteria (10 listed)
- History of severe allergies or severe specific allergic diseases/history (asthma, urticaria, eczematous dermatitis, etc.) or allergic constitution (allergic to two or more foods or drugs), known or suspected allergy to any excipient of BGM0504 Injection.
- Previous diagnosis of type 1 or type 2 diabetes, or clinically significant abnormal HbA1c at screening.
- Family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 syndrome.
- History of acute/chronic pancreatitis, pancreatic injury, or other high-risk factors for pancreatitis.
- Past or screening findings of digestive system diseases that may increase participant risk.
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 |
|---|---|---|
| BGM0504 Injection multi-dose pen5 mg, single subcutaneous injection in the abdominal region | Drug | BGM0504 Injection multi-dose pen |
| BGM0504 Injection single-dose pen5 mg, single subcutaneous injection in the abdominal region | Drug | BGM0504 Injection single-dose pen |
| BGM0504 Injection single-dose pen5 mg, single subcutaneous injection in the abdominal region | Drug | BGM0504 Injection single-dose pen-2 |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: 0 to 672 hours
Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC)0-t
Time frame: 0 to 672 hours
Area under the plasma concentration versus time curve (AUC)0-t
1 secondary outcome
Monitor all the adverse event
Time frame: 29 days
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 16 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 Injection multi-dose pen and BGM0504 Injection single-dose pen in people with Overweight/Obesity, 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 4 inclusion and 10 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 16 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?
Peak Plasma Concentration (Cmax) (time frame: 0 to 672 hours). The study lists 2 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 16 Oct 2026.