Type 2 Diabetes (T2DM)Phase 3NCT07743983
A Study of BGM0504 in Early T2DM With Obesity
A Phase 3 study testing BGM0504 and semaglutide in people with Type 2 Diabetes (T2DM), run by BrightGene Bio-Medical Technology Co., Ltd. at 1 site in China.
Trial summary
This trial is conducted in China. The aim is to compare BGM0504 Injection 15 mg with semaglutide 1.0 mg in Chinese T2DM patients with obesity and inadequate control despite diet and exercise. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes (T2DM)
- What is being tested?
- BGM0504 and semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 372 participants
- Where
- 1 siteChina
- Study dates
- 17 Sep 2026to 30 Nov 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ○ Have been diagnosed with type 2 diabetes mellitus (T2DM)， disease duration ≤5 years, treatment naïve with ≥8 weeks diet/exercise, or off antidiabetic therapy ≥8 weeks prior to screening.
- BMI 28.0-35.0 kg/m² at screening, with stable weight (±5%) for 3 months prior to screening.
- Have HbA1c between ≥7.5% and ≤10.5% at screening.
- FPG ≤15.0 mmol/L at screening.
- If hypertensive: SBP <180 mmHg and DBP <110 mmHg at enrollment, on stable (≥2 weeks) ≤2 antihypertensives, or no medication with diet/exercise ≥4 weeks.
- Willing to comply with protocol, use effective contraception, and provide informed consent.
Who cannot join
- ● Previous diagnosis of type 1 diabetes, special type diabetes or gestational diabetes.
- Prior use of antidiabetics or systemic glucocorticoids within 8 weeks, prior GLP-1/GIP/GCG receptor agonists with intolerance/poor response, or weight-loss drugs within 3 months.
- History of acute/chronic pancreatitis.
- Medullary thyroid carcinoma, MEN 2A/2B, or family history.
- Malignancy within 5 years (except treated BCC/SCC, cervical/PSC/thyroid papillary carcinoma in situ with no recurrence).
- Severe cardiac conditions within 6 months: NYHA III/IV HF, unstable angina, MI, CABG/stent, severe arrhythmias.
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- Hemorrhagic or ischemic stroke within 6 months.
- Severe renal disease or eGFR ≤60 mL/min/1.73 m² (CKD-EPI).
- Pregnant or lactating woman.
- Prior clinical trial participation with investigational drug or device within 3 months.
- Other situations that are deemed as inappropriate for participation by investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanjing Drum Tower Hospital（The Affiliated Hospital of Nanjing University Medical School）
Nanjing, Jiangsu, 210008
About this study
Official title: A Randomized, Open-Label, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety, and Diabetes Remission of BGM0504 Injection Compared With Semaglutide Injection in Early-Stage Chinese Type 2 Diabetes Mellitus Patients With Obesity and Inadequate Glycemic and Weight Control Despite Diet and Exercise Intervention（BRIGHT-1）
This trial is conducted in China. The aim is to compare BGM0504 Injection 15 mg with semaglutide 1.0 mg in Chinese T2DM patients with obesity and inadequate control despite diet and exercise. Over 52 weeks of once weekly treatment, efficacy and safety are evaluated, including the rate of diabetes remission at 12 weeks after treatment discontinuation.
- Conditions
- Type 2 Diabetes (T2DM)
- Being tested
- BGM0504, semaglutide
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGM0504Drug
Administered as a subcutaneous injection once weekly for 52 weeks.
semaglutideDrug
Administered as a subcutaneous injection once weekly for 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| BGM0504 Injection 15 mg | Experimental | Not described Receives: Drug: BGM0504 |
| Semaglutide Injection 1.0 mg | Active comparator | Not described Receives: Drug: semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Achieving HbA1c < 7.0% and Body Weight Reduction ≥ 10% from Baseline
Composite endpoint assessing both glycemic control and weight loss.
Measured: Week 52
Secondary outcomes (16)
Proportion of Participants Achieving Diabetes Remission
Defined as HbA1c < 6.5% without use of glucose-lowering medications.
Measured: Week 64 (12 weeks off treatment)
Proportion of Participants Achieving HbA1c < 7.0% with Weight Reduction ≥10% from Baseline
Composite endpoint assessing combined glycemic and weight outcomes at multiple thresholds.
Measured: Weeks 12, 24, 36, 44
Proportion of Participants Achieving HbA1c < 7.0% with Weight Reduction ≥ 5%, or 15% from Baseline
Composite endpoint assessing combined glycemic and weight outcomes at multiple thresholds.
Measured: Weeks 12, 24, 36, 44, 52
Proportion of Participants Achieving HbA1c Targets (< 7.0%, ≤ 6.5%, < 5.7%)
Glycemic control assessed at each visit.
Measured: Weeks 12, 24, 36, 44, 52
Proportion of Participants Achieving HbA1c ≤ 6.5% or < 5.7% with Weight Reduction ≥ 5%, 10%, or 15% from Baseline
Composite endpoint assessing stricter glycemic targets combined with weight loss.
Measured: Weeks 12, 24, 36, 44, 52
Proportion of Participants Achieving Glycemic and Weight Targets at 12 Weeks Off Treatment
Composite of HbA1c < 5.7% or < 6.5% with weight reduction ≥ 5% or ≥ 10%, assessing durability of response after treatment withdrawal.
Measured: Week 64
Change from Baseline in HbA1c
Absolute change in glycated hemoglobin from baseline.
Measured: Weeks 12, 24, 36, 44, 52
Change from Baseline in Fasting Plasma Glucose (FPG)
Absolute change in fasting glucose from baseline.
Measured: Weeks 12, 24, 36, 44, 52
Change from Baseline in 2-Hour Postprandial Glucose
Glucose measured 2 hours after a standard meal, absolute change from baseline.
Measured: Week 52
Change from Baseline in Body Weight
Absolute and percentage change in body weight
Measured: Weeks 12, 24, 36, 44, 52
Change from Baseline in BMI
Absolute and percentage change in BMI (kg/m²).
Measured: Weeks 12, 24, 36, 44, 52
Change from Baseline in Waist Circumference and Hip Circumference
Absolute change in waist and hip circumference from baseline.
Measured: Weeks 12, 24, 36, 44, 52
Proportion of Participants Achieving Weight Reduction ≥ 5%, 10%, 15%, and 20% from Baseline
Categorical weight loss responders at multiple thresholds.
Measured: Weeks 12, 24, 36, 44, 52
Percentage Change from Baseline in Lipid Profile (TC, TG, LDL-C, HDL-C)
Percentage change in total cholesterol, triglycerides, LDL-C, and HDL-C from baseline.
Measured: Weeks 12, 24, 36, 44, 52
Change from Baseline in Systolic and Diastolic Blood Pressure (SBP/DBP)
Absolute change in seated SBP and DBP from baseline.
Measured: Weeks 12, 24, 36, 44, 52
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Includes adverse events, serious adverse events, and hypoglycemic events.
Measured: Baseline to 64 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start17 Sep 2026
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 372 participants (estimated)
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
- NCT07743983
- Sponsor's protocol ID
- BGM0504-Ⅲ -T2DM-03
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- 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 Randomized, Open-Label, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety, and Diabetes Remission of BGM0504 Injection Compared With Semaglutide Injection in Early-Stage Chinese Type 2 Diabetes Mellitus Patients With Obesity and Inadequate Glycemic and Weight Control Despite Diet and Exercise Intervention（BRIGHT-1）
- ClinicalTrials.gov ID
- NCT07743983
- Acronym / sponsor ID
- BGM0504-Ⅲ -T2DM-03
- Conditions
- Type 2 Diabetes (T2DM)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 372 participants (estimated)
- Lead sponsor
- BrightGene Bio-Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Sep 2026 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 4 Aug 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 trial is conducted in China. The aim is to compare BGM0504 Injection 15 mg with semaglutide 1.0 mg in Chinese T2DM patients with obesity and inadequate control despite diet and exercise. Over 52 weeks of once weekly treatment, efficacy and safety are evaluated, including the rate of diabetes remission at 12 weeks after treatment discontinuation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BGM0504 Injection 15 mg | Experimental | Drug: BGM0504 |
| Semaglutide Injection 1.0 mg | Active comparator | Drug: semaglutide |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ○ Have been diagnosed with type 2 diabetes mellitus (T2DM)， disease duration ≤5 years, treatment naïve with ≥8 weeks diet/exercise, or off antidiabetic therapy ≥8 weeks prior to screening.
Key exclusion criteria (11 listed)
- ● Previous diagnosis of type 1 diabetes, special type diabetes or gestational diabetes.
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 as a subcutaneous injection once weekly for 52 weeks. | Drug | BGM0504 Injection 15 mg |
| semaglutideAdministered as a subcutaneous injection once weekly for 52 weeks. | Drug | Semaglutide Injection 1.0 mg |
Primary outcome
Proportion of Participants Achieving HbA1c < 7.0% and Body Weight Reduction ≥ 10% from Baseline
Time frame: Week 52
Composite endpoint assessing both glycemic control and weight loss.
16 secondary outcomes
Proportion of Participants Achieving Diabetes Remission
Time frame: Week 64 (12 weeks off treatment)
Proportion of Participants Achieving HbA1c < 7.0% with Weight Reduction ≥10% from Baseline
Time frame: Weeks 12, 24, 36, 44
Proportion of Participants Achieving HbA1c < 7.0% with Weight Reduction ≥ 5%, or 15% from Baseline
Time frame: Weeks 12, 24, 36, 44, 52
Proportion of Participants Achieving HbA1c Targets (< 7.0%, ≤ 6.5%, < 5.7%)
Time frame: Weeks 12, 24, 36, 44, 52
Proportion of Participants Achieving HbA1c ≤ 6.5% or < 5.7% with Weight Reduction ≥ 5%, 10%, or 15% from Baseline
Time frame: Weeks 12, 24, 36, 44, 52
Proportion of Participants Achieving Glycemic and Weight Targets at 12 Weeks Off Treatment
Time frame: Week 64
Change from Baseline in HbA1c
Time frame: Weeks 12, 24, 36, 44, 52
Change from Baseline in Fasting Plasma Glucose (FPG)
Time frame: Weeks 12, 24, 36, 44, 52
Change from Baseline in 2-Hour Postprandial Glucose
Time frame: Week 52
Change from Baseline in Body Weight
Time frame: Weeks 12, 24, 36, 44, 52
Change from Baseline in BMI
Time frame: Weeks 12, 24, 36, 44, 52
Change from Baseline in Waist Circumference and Hip Circumference
Time frame: Weeks 12, 24, 36, 44, 52
Proportion of Participants Achieving Weight Reduction ≥ 5%, 10%, 15%, and 20% from Baseline
Time frame: Weeks 12, 24, 36, 44, 52
Percentage Change from Baseline in Lipid Profile (TC, TG, LDL-C, HDL-C)
Time frame: Weeks 12, 24, 36, 44, 52
Change from Baseline in Systolic and Diastolic Blood Pressure (SBP/DBP)
Time frame: Weeks 12, 24, 36, 44, 52
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Baseline to 64 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
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.
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 BGM0504 and semaglutide in people with Type 2 Diabetes (T2DM), 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 6 inclusion and 11 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: looking for participants now, 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhu (+86025-68182432, zhudalong@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Achieving HbA1c < 7.0% and Body Weight Reduction ≥ 10% from Baseline (time frame: Week 52). 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.