ObesityPhase 2NCT06911203
A Study of BGM0504 in Participants With Obesity
A Phase 2 study testing BGM0504 and Tirzepatide in people with Obesity, run by BrightGene Bio-Medical Technology Co., Ltd. at 1 site in China.
Trial summary
To evaluate the efficacy and safety of BGM0504 compared with Tirzepatide in adult participants who have obesity without diabetes after 26 weeks of treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- BGM0504 and Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 9 Apr 2025to 14 Jan 2026
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ● Able and willing to provide a written informed consent.
- Male or female subjects, 18-65 years of age at the time of signing informed consent.
- At screening visit, 35.0 ﹤BMI﹤ 45.0 kg/m2;
- Diet and exercise control for at least 3 months before screening visit, and be of stable weight (± 5%) self-reported change within the last 3 months.
Who cannot join
- ●History of chronic or acute pancreatitis.
- History of severe drug allergy or specific allergic disease or severe allergies.
- Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2(MEN-2).
- History of malignant tumors [except carcinoma in situ with no recurrence within 5 years (except for malignant melanoma in situ), skin basal cell carcinoma and squamous cell carcinoma].
- Suspected or confirmed history of alcohol or drug abuse;
- Any chronic infections likely to interfere with study conduct or interpretation such as hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) or treponema pallidum (TP).
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- Donation or loss of 400 mL or more of blood within 3 months prior to screening, or blood donation during screening or within 3 months after the end of the trial.
- Pregnant or lactating woman.
- Any disorder, unwillingness, or inability not covered by any of the other exclusion criteria, which in the Investigator's opinion, might jeopardize the participant's safety or compliance with the protocol.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: A Phase II, Randomized Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BGM0504 Compared to Tirzepatide in Adults Who Have Obesity
To evaluate the efficacy and safety of BGM0504 compared with Tirzepatide in adult participants who have obesity without diabetes after 26 weeks of treatment.
- Conditions
- Obesity
- Being tested
- BGM0504, Tirzepatide
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGM0504Drug
Administered SC
TirzepatideDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| BGM0504 | Experimental | Participants will receive BGM0504 subcutaneously(SC). Receives: Drug: BGM0504 |
| Tirzepatide | Active comparator | Paritcipants will receive tirzepatide SC. Receives: Drug: Tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Body Weight
Change from baseline in body weight after 26 weeks of treatment
Measured: Week 0, Week 26
Secondary outcomes (5)
Change From Baseline in BMI
Change from baseline in BMI after 26 weeks of treatment
Measured: Week 18, Week 26
Change From Baseline in Waist Circumference
Change from baseline in waist circumference after 26 weeks of treatment
Measured: Week 18, Week 26
Change from Baseline in Systolic Blood Pressure (SBP)
Change from Baseline in SBP after 26 weeks of treatment
Measured: Week 18, Week 26
Change from Baseline in Diastolic Blood Pressure (DBP)
Change from Baseline in DBP after 26 weeks of treatment
Measured: Week 18, Week 26
Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT)
Change from Baseline in IWQOL-Lite-CT after 26 weeks of treatment
Measured: Week 0, Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start9 Apr 2025
- Primary completion14 Jan 2026
- Study completion14 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 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
- NCT06911203
- Sponsor's protocol ID
- BGM0504-II -WL-02
- Status last verified
- Oct 2026
- First submitted
- 3 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 Phase II, Randomized Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BGM0504 Compared to Tirzepatide in Adults Who Have Obesity
- ClinicalTrials.gov ID
- NCT06911203
- Acronym / sponsor ID
- BGM0504-II -WL-02
- Conditions
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- BrightGene Bio-Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Apr 2025 (actual)
- Primary completion
- 14 Jan 2026 (actual)
- Study completion
- 14 Jan 2026 (actual)
- First posted
- 4 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.
To evaluate the efficacy and safety of BGM0504 compared with Tirzepatide in adult participants who have obesity without diabetes after 26 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BGM0504 | Experimental | Drug: BGM0504Participants will receive BGM0504 subcutaneously(SC). |
| Tirzepatide | Active comparator | Drug: TirzepatideParitcipants will receive tirzepatide SC. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ● Able and willing to provide a written informed consent.
Key exclusion criteria (9 listed)
- ●History of chronic or acute pancreatitis.
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 |
|---|---|---|
| BGM0504Administered SC | Drug | BGM0504 |
| TirzepatideAdministered SC | Drug | Tirzepatide |
Primary outcome
Change From Baseline in Body Weight
Time frame: Week 0, Week 26
Change from baseline in body weight after 26 weeks of treatment
5 secondary outcomes
Change From Baseline in BMI
Time frame: Week 18, Week 26
Change From Baseline in Waist Circumference
Time frame: Week 18, Week 26
Change from Baseline in Systolic Blood Pressure (SBP)
Time frame: Week 18, Week 26
Change from Baseline in Diastolic Blood Pressure (DBP)
Time frame: Week 18, Week 26
Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT)
Time frame: Week 0, Week 26
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 2 study testing BGM0504 and Tirzepatide in people with 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 9 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change From Baseline in Body Weight (time frame: Week 0, Week 26). 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.