Overweight or ObesityPhase 3NCT06704581
A Study of BGM0504 Injection in Participants With Obesity or Overweight
A Phase 3 study testing 5 mg BGM0504 injection, 10 mg BGM0504 injection administered subcutaneously (SC) once a week and 15 mg BGM0504 injection in people with Overweight or Obesity, run by BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd. at 1 site in China.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled phase III validation clinical study in Chinese adult non-diabetic overweight or obese Participants. The main purpose is to evaluate the clinical efficacy of BGM0504 injection for 36 weeks of administration as an adjunct to diet, exercise, and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight or Obesity
- What is being tested?
- 5 mg BGM0504 injection, 10 mg BGM0504 injection administered subcutaneously (SC) once a week and 15 mg BGM0504 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 652 participants
- Where
- 1 siteChina
- Study dates
- 29 Oct 2024to 17 Mar 2026
- Phase
- Phase 3
- 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
- A male or female aged 18 to 65 years inclusive at screening
- BMI≥28 kg/m², or 24.0≤BMI<28.0 kg/m² and previous diagnosis with at least one of the following comorbidities: i. Prediabetes (impaired fasting blood glucose and/or impaired glucose tolerance), hypertension, nonalcoholic fatty liver disease, or one or more of these; ii. Joint pain with weight bearing; iii. Dyspnea caused by obesity or obstructive sleep apnea syndrome
- Weight change < 5.0% (chief complaint) after diet and exercise control for at least 12 weeks before screening
- Female participants who are not pregnant or lactating. Female participants with childbearing potential and their partners should use highly effective, medically accepted contraception, will not have pregnancy and fertility plan, and refrain from donating ovum until one month after the end of the study
Who cannot join
- Diabetes mellitus
- Known to be allergic to 3 or more kinds of foods or medications, or allergic to GLP-1 agonist, or have a severe allergic disease (asthma, urticaria, eczematous dermatitis, etc.) at screening
- Has been treated with GLP-1 receptor agonists or similar drugs containing the same target, or drugs used for weight control in the three months prior to screening
- Secondary disease or drug-induced obesity, including : elevated cortisol (e.g. Cushing's syndrome), obesity due to pituitary and hypothalamic damage, obesity due to diet drug reduction/discontinuation, etc.;
- History of pancreatitis
- Have the currently uncontrolled thyroid diseases with stable treatment dose and clinically significant abnormal results of thyroid function test occurred at screening
- Previous history of moderate or severe depression, or PHQ-9 score ≥15, or history of other serious mental illness, or Any lifetime history of a suicide attempt
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 Multicenter, Randomized, Double-blind, Placebo-parallel Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of BGM0504 Injection in Chinese Non-diabetes Participants With Overweight or Obese
This is a multicenter, randomized, double-blind, placebo-controlled phase III validation clinical study in Chinese adult non-diabetic overweight or obese Participants. The main purpose is to evaluate the clinical efficacy of BGM0504 injection for 36 weeks of administration as an adjunct to diet, exercise, and behavioral interventions in overweight or obese non-diabetic adults in China for weight management, and to evaluate the clinical efficacy and safety of BGM0504 injection for 52 weeks of administration.
- Conditions
- Overweight or Obesity
- Being tested
- 5 mg BGM0504 injection, 10 mg BGM0504 injection administered subcutaneously (SC) once a week, 15 mg BGM0504 injection, 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.
5 mg BGM0504 injectionDrug
5mg BGM0504 injection administered subcutaneously (SC) once a week.
10 mg BGM0504 injection administered subcutaneously (SC) once a weekDrug
10mg BGM0504 injection administered subcutaneously (SC) once a week.
15 mg BGM0504 injectionDrug
15mg BGM0504 injection administered subcutaneously (SC) once a week.
BGM0504 placeboDrug
BGM0504 placebo administered SC once a week.
| Study group | Role | What they receive |
|---|---|---|
| 5 mg BGM0504 injection | Experimental | Not described Receives: Drug: 5 mg BGM0504 injection |
| 10 mg BGM0504 injection | Experimental | Not described Receives: Drug: 10 mg BGM0504 injection administered subcutaneously (SC) once a week |
| 15 mg BGM0504 injection | Experimental | Not described Receives: Drug: 15 mg BGM0504 injection |
| BGM0504 placebo | Placebo comparator | Not described Receives: Drug: BGM0504 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change from Baseline in Body Weight
Change from baseline in body weight after 36 weeks of treatment
Measured: Baseline,Week 36
Percentage of Participants Who Achieve≥5% Body Weight Reduction
Percentage of Participants Who Achieve≥5% Body Weight Reduction
Measured: Baseline,Week 36
Secondary outcomes (10)
Percent Change From Baseline in Body Weight
Percent Change from Baseline in Body Weight after 52weeks of treatment
Measured: Baseline, Week 52
Change From Baseline in Body Weight
Change from baseline in body weight
Measured: Baseline, Week36 and 52
Percentage of Participants Who Achieve≥5% Body Weight Reduction
Percentage of Participants Who Achieve≥5% Body Weight Reduction
Measured: Baseline, Week 36 and 52
Percentage of Participants Who Achieve≥10% Body Weight Reduction
Percentage of Participants Who Achieve≥10% Body Weight Reduction
Measured: Baseline, Week 36 and 52
Percentage of Participants Who Achieve≥15%Body Weight Reduction
Percentage of Participants Who Achieve≥15%Body Weight Reduction
Measured: Baseline, Week 36 and 52
Percentage of Participants Who Achieve≥20% Body Weight Reduction
Percentage of Participants Who Achieve≥20% Body Weight Reduction.
Measured: Baseline, Week 36 and 52
Change From Baseline in Waist Circumference
Change From Baseline in Waist Circumference after 52weeks of treatment.
Measured: Baseline, Week 36 and 52
Change From Baseline in Body Mass Index (BMI)
Change From Baseline in Body Mass Index (BMI) after 52weeks of treatment
Measured: Baseline, Week 36 and 52
Change From Baseline in Fasting Glucose
Change From Baseline in Fasting Glucose after 52weeks of treatment
Measured: Baseline, Week 36 and 52
Change From Baseline in Hemoglobin A1c (HbA1c)
Change From Baseline in Hemoglobin A1c (HbA1c) after 52weeks of treatment.
Measured: Baseline, Week 36 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start29 Oct 2024
- Primary completion17 Mar 2026
- Study completion17 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 652 participants (actual)
Sponsor and investigators
- Lead sponsor
- BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704581
- Sponsor's protocol ID
- BGM0504-Ⅲ-WL
- Status last verified
- Oct 2026
- First submitted
- 7 Nov 2024
- Last updated
- 15 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 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-parallel Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of BGM0504 Injection in Chinese Non-diabetes Participants With Overweight or Obese
- ClinicalTrials.gov ID
- NCT06704581
- Acronym / sponsor ID
- BGM0504-Ⅲ-WL
- Conditions
- Overweight or Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 652 participants (actual)
- Lead sponsor
- BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- 17 Mar 2026 (actual)
- Study completion
- 17 Mar 2026 (actual)
- First posted
- 26 Nov 2024 (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 multicenter, randomized, double-blind, placebo-controlled phase III validation clinical study in Chinese adult non-diabetic overweight or obese Participants. The main purpose is to evaluate the clinical efficacy of BGM0504 injection for 36 weeks of administration as an adjunct to diet, exercise, and behavioral interventions in overweight or obese non-diabetic adults in China for weight management, and to evaluate the clinical efficacy and safety of BGM0504 injection for 52 weeks of administration.
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 injection | Experimental | Drug: 5 mg BGM0504 injection |
| 10 mg BGM0504 injection | Experimental | Drug: 10 mg BGM0504 injection administered subcutaneously (SC) once a week |
| 15 mg BGM0504 injection | Experimental | Drug: 15 mg BGM0504 injection |
| BGM0504 placebo | Placebo comparator | Drug: BGM0504 placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A male or female aged 18 to 65 years inclusive at screening
- BMI≥28 kg/m², or 24.0≤BMI<28.0 kg/m² and previous diagnosis with at least one of the following comorbidities: i. Prediabetes (impaired fasting blood glucose and/or impaired glucose tolerance), hypertension, nonalcoholic fatty liver disease, or one or more of these; ii. Joint pain with weight bearing; iii. Dyspnea caused by obesity or obstructive sleep apnea syndrome
- Weight change < 5.0% (chief complaint) after diet and exercise control for at least 12 weeks before screening
- Female participants who are not pregnant or lactating. Female participants with childbearing potential and their partners should use highly effective, medically accepted contraception, will not have pregnancy and fertility plan, and refrain from donating ovum until one month after the end of the study
Key exclusion criteria (7 listed)
- Diabetes mellitus
- Known to be allergic to 3 or more kinds of foods or medications, or allergic to GLP-1 agonist, or have a severe allergic disease (asthma, urticaria, eczematous dermatitis, etc.) at screening
- Has been treated with GLP-1 receptor agonists or similar drugs containing the same target, or drugs used for weight control in the three months prior to screening
- Secondary disease or drug-induced obesity, including : elevated cortisol (e.g. Cushing's syndrome), obesity due to pituitary and hypothalamic damage, obesity due to diet drug reduction/discontinuation, etc.;
- History of 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 |
|---|---|---|
| 5 mg BGM0504 injection5mg BGM0504 injection administered subcutaneously (SC) once a week. | Drug | 5 mg BGM0504 injection |
| 10 mg BGM0504 injection administered subcutaneously (SC) once a week10mg BGM0504 injection administered subcutaneously (SC) once a week. | Drug | 10 mg BGM0504 injection |
| 15 mg BGM0504 injection15mg BGM0504 injection administered subcutaneously (SC) once a week. | Drug | 15 mg BGM0504 injection |
| BGM0504 placeboBGM0504 placebo administered SC once a week. | Drug | BGM0504 placebo |
Primary outcome
Percent Change from Baseline in Body Weight
Time frame: Baseline,Week 36
Change from baseline in body weight after 36 weeks of treatment
Percentage of Participants Who Achieve≥5% Body Weight Reduction
Time frame: Baseline,Week 36
Percentage of Participants Who Achieve≥5% Body Weight Reduction
10 secondary outcomes
Percent Change From Baseline in Body Weight
Time frame: Baseline, Week 52
Change From Baseline in Body Weight
Time frame: Baseline, Week36 and 52
Percentage of Participants Who Achieve≥5% Body Weight Reduction
Time frame: Baseline, Week 36 and 52
Percentage of Participants Who Achieve≥10% Body Weight Reduction
Time frame: Baseline, Week 36 and 52
Percentage of Participants Who Achieve≥15%Body Weight Reduction
Time frame: Baseline, Week 36 and 52
Percentage of Participants Who Achieve≥20% Body Weight Reduction
Time frame: Baseline, Week 36 and 52
Change From Baseline in Waist Circumference
Time frame: Baseline, Week 36 and 52
Change From Baseline in Body Mass Index (BMI)
Time frame: Baseline, Week 36 and 52
Change From Baseline in Fasting Glucose
Time frame: Baseline, Week 36 and 52
Change From Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline, Week 36 and 52
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 15 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 3 study testing 5 mg BGM0504 injection, 10 mg BGM0504 injection administered subcutaneously (SC) once a week and 15 mg BGM0504 injection in people with Overweight or Obesity, run by BrightGene New Bio-Medical Technology(Wuxi) 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 7 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 15 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Percent Change from Baseline in Body Weight (time frame: Baseline,Week 36). 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 15 Oct 2026.