Type 2 Diabetes Mellitus (T2DM)Phase 3NCT06716203
A Study of BGM0504 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise
A Phase 3 study testing Drug: 5 mg BGM0504 Administered SC and Drug: : 10 mg BGM0504 Administered SC in people with Type 2 Diabetes Mellitus (T2DM), run by BrightGene Bio-Medical Technology Co., Ltd. at 1 site in China.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of BGM0504 in patients with type 2 diabetes (T2D) with poor glycemic control only through 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 Mellitus (T2DM)
- What is being tested?
- Drug: 5 mg BGM0504 Administered SC and Drug: : 10 mg BGM0504 Administered SC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 207 participants
- Where
- 1 siteChina
- Study dates
- 3 Jan 2025to 14 Nov 2026
- 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);
- Have a BMI ≥23 kilograms per meter squared (kg/m²) at screening;
- Be of stable weight (± 5%) for at least 3 months before screening;
- Have HbA1c between ≥7.5% and ≤11.0%；
- Fasting Plasma Glucose (FPG) ≤ 15.0 mmoL/L.
Who cannot join
- ■ Previous diagnosis of type 1 diabetes, special type diabetes ;
- There are malignant tumors within 5 years before screening, or patients are in latent of clinical malignant tumors (except patients with skin basal cell carcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ or papillary thyroid carcinoma who have no recurrence after surgery).
- Have had chronic or acute pancreatitis any time prior to study entry;
- Known allergic constitution (allergy to 3 or more kinds of food or drugs), or allergy to GLP-1 receptor agonists, or severe allergic diseases (asthma, urticaria, eczematous dermatitis, etc.) at screening;
- Mentally incapacitated or speech-impaired;
- Suspected or confirmed history of alcohol or drug abuse;
- Pregnant or lactating woman;
- The investigator considers that there are any other conditions that make it inappropriate to participate in this study.
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 Randomized, Double-blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of BGM0504 Versus Placebo in Patients With Type 2 Diabetes, Inadequately Controlled With Diet and Exercise Alone
This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of BGM0504 in patients with type 2 diabetes (T2D) with poor glycemic control only through diet and exercise.
The main purpose is to evaluate the clinical efficacy of BGM0504 injection monotherapy for 32 weeks compared with placebo in Chinese patients with type 2 diabetes with poor glycemic control only through diet and exercise, and to evaluate the clinical efficacy and safety of BGM0504 injection for 52 weeks of administration.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- Drug: 5 mg BGM0504 Administered SC, Drug: : 10 mg BGM0504 Administered SC, Drug: Placebo Administered SC
- 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.
Drug: 5 mg BGM0504 Administered SCDrug
Drug: BGM0504 Administered SC
Drug: : 10 mg BGM0504 Administered SCDrug
Drug: BGM0504 Administered SC
Drug: Placebo Administered SCDrug
Drug: Placebo Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Experimental: 5 mg BGM0504 | Experimental | Experimental: 5 mg BGM0504 5 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week. |
| Experimental: 10 mg BGM0504 | Experimental | Experimental: 10 mg BGM0504 10 mg BGM0504 administered SC once a week. Receives: Drug: Drug: : 10 mg BGM0504 Administered SC |
| Placebo Comparator: Placebo | Placebo comparator | Placebo Comparator: Placebo Placebo administered subcutaneously (SC) once a week. Receives: Drug: Drug: Placebo Administered SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Hemoglobin A1c (HbA1c)
Change from baseline in HbA1c after 32 weeks of treatment.
Measured: Week 0 to Week 32
Secondary outcomes (5)
Change From Baseline in Body Weight
Change from baseline in body weight after 52 weeks of treatment.
Measured: Week 0 to Week 52
Change From Baseline in Hemoglobin A1c (HbA1c)
Change from baseline in HbA1c after 52weeks of treatment.
Measured: Week 0 to Week 52
Percentage of Participants With HbA1c Target Value of <7%
Percentage of Participants With HbA1c Target Value of <7% after 52weeks of treatment.
Measured: Week 0 to Week 52
Percentage of Participants With HbA1c Target Value of <5.7%
Percentage of Participants With HbA1c Target Value of <5.7%after 52weeks of treatment.
Measured: Week 0 to Week 52
Change From Baseline in Fasting Serum Glucose
Change from baseline in FPG after 52 weeks of treatment.
Measured: Week 0 to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start3 Jan 2025
- Primary completion14 Nov 2026 (estimated)
- Study completion14 Nov 2026 (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 Mellitus (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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 207 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BrightGene Bio-Medical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716203
- Sponsor's protocol ID
- BGM0504-Ⅲ -T2DM-01
- Status last verified
- Oct 2026
- First submitted
- 29 Nov 2024
- Last updated
- 15 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 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of BGM0504 Versus Placebo in Patients With Type 2 Diabetes, Inadequately Controlled With Diet and Exercise Alone
- ClinicalTrials.gov ID
- NCT06716203
- Acronym / sponsor ID
- BGM0504-Ⅲ -T2DM-01
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 207 participants (estimated)
- Lead sponsor
- BrightGene Bio-Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd.
- Study start
- 3 Jan 2025 (actual)
- Primary completion
- 14 Nov 2026 (estimated)
- Study completion
- 14 Nov 2026 (estimated)
- First posted
- 4 Dec 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 clinical study to evaluate the efficacy and safety of BGM0504 in patients with type 2 diabetes (T2D) with poor glycemic control only through diet and exercise.
The main purpose is to evaluate the clinical efficacy of BGM0504 injection monotherapy for 32 weeks compared with placebo in Chinese patients with type 2 diabetes with poor glycemic control only through diet and exercise, 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
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: 5 mg BGM0504 | Experimental | –Experimental: 5 mg BGM0504 5 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week. |
| Experimental: 10 mg BGM0504 | Experimental | Drug: Drug: : 10 mg BGM0504 Administered SCExperimental: 10 mg BGM0504 10 mg BGM0504 administered SC once a week. |
| Placebo Comparator: Placebo | Placebo comparator | Drug: Drug: Placebo Administered SCPlacebo Comparator: Placebo Placebo administered subcutaneously (SC) once a week. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ☑ Have been diagnosed with type 2 diabetes mellitus (T2DM);
Key exclusion criteria (8 listed)
- ■ Previous diagnosis of type 1 diabetes, special type 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 |
|---|---|---|
| Drug: 5 mg BGM0504 Administered SCDrug: BGM0504 Administered SC | Drug | – |
| Drug: : 10 mg BGM0504 Administered SCDrug: BGM0504 Administered SC | Drug | Experimental: 10 mg BGM0504 |
| Drug: Placebo Administered SCDrug: Placebo Administered SC | Drug | Placebo Comparator: Placebo |
Primary outcome
Change From Baseline in Hemoglobin A1c (HbA1c)
Time frame: Week 0 to Week 32
Change from baseline in HbA1c after 32 weeks of treatment.
5 secondary outcomes
Change From Baseline in Body Weight
Time frame: Week 0 to Week 52
Change From Baseline in Hemoglobin A1c (HbA1c)
Time frame: Week 0 to Week 52
Percentage of Participants With HbA1c Target Value of <7%
Time frame: Week 0 to Week 52
Percentage of Participants With HbA1c Target Value of <5.7%
Time frame: Week 0 to Week 52
Change From Baseline in Fasting Serum Glucose
Time frame: Week 0 to Week 52
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 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 Drug: 5 mg BGM0504 Administered SC and Drug: : 10 mg BGM0504 Administered SC in people with Type 2 Diabetes Mellitus (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 5 inclusion and 8 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: under way, not looking for participants, 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?
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?
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 Hemoglobin A1c (HbA1c) (time frame: Week 0 to Week 32). 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.