Overweight or ObesityPhase 2NCT06973681
A Study of BGM0504 Evaluating Weight Loss in Overweight or Obese Chinese Subjects
A Phase 2 study testing BGM0504 in people with Overweight or Obesity, run by BrightGene Bio-Medical Technology Co., Ltd. at 1 site in China.
Trial summary
To assess the effect of BGM0504 injection versus placebo on weight loss in overweight or obese subjects after 24 weeks of treatment. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Overweight or Obesity
- What is being tested?
- BGM0504
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 13 Oct 2023to 13 Sep 2024
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI ≥ 28.0 kg/m2 or 24.0 ≤ BMI < 28.0 kg/m2 with at least 1 weight-related comorbidity at screening visit;
- Controlled by diet and exercise alone for at least 12 weeks prior to Screening with <5.0% change in body weight and able to continue the original diet and exercise for weight control during the trial.
- Exclusion Criteria:● Those who have used weight loss drugs within 12 weeks before screening;
- Previous diagnosis of type 1 or type 2 diabetes mellitus;
- History of acute or chronic pancreatitis, or pancreatic injury;
- History of thyroid C-cell carcinoma, MEN (multiple endocrine adenomatosis) 2A or 2B, or relevant family history;
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- Subjects with uncontrolled hypertension after treatment (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥ 100 mmHg at screening) or untreated blood pressure meeting the above criteria at screening;
- Concomitant thyroid dysfunction that cannot be controlled at a stable drug dose atscreening, or clinically significant abnormalities in thyroid function test results at screening that require initiation of therapy;
- At Screening, abdominal ultrasound indicated calculus gallbladder and polyps, or presence of clinical symptoms of gallbladder disease at Screening;
- Pregnant or breastfeeding women.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase II Clinical Study to Evaluate the Safety, Tolerability, PK/PD Profile, and Efficacy of Multiple Doses of BGM0504 Injection in Overweight or Obese Subjects Without Diabetes
To assess the effect of BGM0504 injection versus placebo on weight loss in overweight or obese subjects after 24 weeks of treatment.
- Conditions
- Overweight or Obesity
- Being tested
- BGM0504, Placebo
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGM0504Drug
Administered SC
BGM0504Drug
Administered SC
BGM0504Drug
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| 5 mg BGM0504 | Experimental | 5 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week. Receives: Drug: BGM0504 |
| 10 mg BGM0504 | Experimental | 10 mg BGM0504 administered SC once a week. Receives: Drug: BGM0504 |
| 15 mg BGM0504 | Experimental | 15 mg BGM0504 administered SC once a week. Receives: Drug: BGM0504 |
| Placebo | Placebo comparator | Placebo administered SC once a week. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in body weight
Percentage change from baseline in body weight after 24 weeks of treatment.
Measured: Week 0 to Week 24
Secondary outcomes (4)
Proportion of Subjects with weight loss of ≥5%
Proportion of Subjects with weight loss of ≥5% from baseline in body weight after 24 weeks of treatment
Measured: Week 0 to Week 24
Change from baseline in waist circumference
Change from baseline in waist circumference after 24 weeks of treatment
Measured: Week 0 to Week 24
Change from baseline in BMI
Change from baseline in BMI after 24 weeks of treatment
Measured: Week 0 to Week 24
Change from baseline in fasting plasma glucose (FPG)
Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment
Measured: Week 0 to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start13 Oct 2023
- Primary completion13 Sep 2024
- Study completion13 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight or 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 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
- NCT06973681
- Sponsor's protocol ID
- BGM0504-II-WL
- Status last verified
- Jun 2023
- First submitted
- 14 May 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Ji L, Yang G, Huang Y, Ding H, Xie D, Jiang X, Yuan X, Cao Z, Chan Z, Zhang H, Yuan J. Effectiveness, Safety and Pharmacokinetics of BGM0504, a Dual GLP-1/GIP Receptor Agonist, in Chinese Adults With Overweight or Obesity Without Diabetes: A Phase 2 Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial. Diabetes Obes Metab. 2026 Sep 17. doi: 10.1111/dom.71193. Online ahead of print.
PubMed 42755112
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 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase II Clinical Study to Evaluate the Safety, Tolerability, PK/PD Profile, and Efficacy of Multiple Doses of BGM0504 Injection in Overweight or Obese Subjects Without Diabetes
- ClinicalTrials.gov ID
- NCT06973681
- Acronym / sponsor ID
- BGM0504-II-WL
- Conditions
- Overweight or Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- BrightGene Bio-Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Oct 2023 (actual)
- Primary completion
- 13 Sep 2024 (actual)
- Study completion
- 13 Sep 2024 (actual)
- First posted
- 15 May 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 assess the effect of BGM0504 injection versus placebo on weight loss in overweight or obese subjects after 24 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 5 mg BGM0504 | Experimental | Drug: BGM05045 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week. |
| 10 mg BGM0504 | Experimental | Drug: BGM050410 mg BGM0504 administered SC once a week. |
| 15 mg BGM0504 | Experimental | Drug: BGM050415 mg BGM0504 administered SC once a week. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered SC once a week. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- BMI ≥ 28.0 kg/m2 or 24.0 ≤ BMI < 28.0 kg/m2 with at least 1 weight-related comorbidity at screening visit;
- Controlled by diet and exercise alone for at least 12 weeks prior to Screening with <5.0% change in body weight and able to continue the original diet and exercise for weight control during the trial.
- Exclusion Criteria:● Those who have used weight loss drugs within 12 weeks before screening;
- Previous diagnosis of type 1 or type 2 diabetes mellitus;
- History of acute or chronic pancreatitis, or pancreatic injury;
Key exclusion criteria (0 listed)
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 | 10 mg BGM0504 |
| BGM0504Administered SC | Drug | 15 mg BGM0504 |
| BGM0504Administered SC | Drug | 5 mg BGM0504 |
| PlaceboAdministered SC | Drug | Placebo |
Primary outcome
Percentage change in body weight
Time frame: Week 0 to Week 24
Percentage change from baseline in body weight after 24 weeks of treatment.
4 secondary outcomes
Proportion of Subjects with weight loss of ≥5%
Time frame: Week 0 to Week 24
Change from baseline in waist circumference
Time frame: Week 0 to Week 24
Change from baseline in BMI
Time frame: Week 0 to Week 24
Change from baseline in fasting plasma glucose (FPG)
Time frame: Week 0 to Week 24
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.
- Derived from this study: PubMed 42755112Ji L, Yang G, Huang Y, Ding H, Xie D, Jiang X, Yuan X, Cao Z, Chan Z, Zhang H, Yuan J. Effectiveness, Safety and Pharmacokinetics of BGM0504, a Dual GLP-1/GIP Receptor Agonist, in Chinese Adults With Overweight or Obesity Without Diabetes: A Phase 2 Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial. Diabetes Obes Metab. 2026 Sep 17. doi: 10.1111/dom.71193. Online ahead of print.
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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 in people with Overweight or 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 10 inclusion and 0 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. Some participants in this study may receive a placebo. 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?
Percentage change in body weight (time frame: Week 0 to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06973681, which also lists 1 linked publication.
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.