Type 2 Diabetes (T2DM)Phase 3NCT07064486

A Study of BGM0504 in Participants With Type 2 Diabetes in Indonesia

A Phase 3 study testing BGM0504 and Semaglutide in people with Type 2 Diabetes (T2DM), run by BrightGene Bio-Medical Technology Co., Ltd. at 4 sites in Indonesia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This trial is conducted in Indonesia. The aim of the trial is to evaluate the efficacy and safety of BGM0504 versus semaglutide as add-on to metformin in patients with type 2 diabetes 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: 152 participants
Where: 4 sitesIndonesia
Study dates: 4 Jul 2025to 30 Apr 2027
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);
Be on stable treatment with unchanged dose of metformin ≥1500 mg/day or <1500 mg/day but ≥1000 mg/day (the maximum tolerated dose) for at least 8 weeks prior to screening
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% at screening

Who cannot join

○ Previous diagnosis of type 1 diabetes, special type diabetes;
Have suffered the malignancy within the past 5 years (except cured basal cell carcinoma of the skin, cervical carcinoma in situ), or being evaluated for an underlying malignancy;
Have the acute or chronic pancreatitis;
Known to be allergic to 3 or more kinds of foods or medications, or allergic to GLP-1 agonist or metformin, or have a severe allergic disease (asthma, urticaria, eczematous dermatitis, etc.) at screening;
Have a serious mental illness or speech impediment and be unable to fully understand the study;
Suspected or confirmed history of alcohol or drug abuse;
Have had a history of ≥2 severe hypoglycemic episodes in the past 1 year;
Other conditions that may impact the assessment of investigational products, as determined by the Investigator.

Trial locations and contacts

4 sites in 1 country.

Indonesia4 sites

RS Universitas Indonesia
Depok, West Java
RSUP Fatmawati
Jakarta
RSUP Persahabatan
Jakarta
RSUPN Dr. Cipto Mangunkusumo
Jakarta

Other trials in Indonesia

About this study

Official title: A Phase 3, Randomized, Open Label Trial Comparing Efficacy and Safety of BGM0504 Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Patients With Type 2 Diabetes

This trial is conducted in Indonesia. The aim of the trial is to evaluate the efficacy and safety of BGM0504 versus semaglutide as add-on to metformin in patients with type 2 diabetes

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 SC
BGM0504Drug
Administered SC
SemaglutideDrug
Administered SC

Study groups in NCT07064486
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
1 mg Semaglutide	Active comparator	1 mg semaglutide administered SC once a week Receives: Drug: Semaglutide

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 24 weeks of treatment.
Measured: Week 0 to Week 24

Secondary outcomes (5)

Change From Baseline in Hemoglobin A1c (HbA1c)
Change from baseline in HbA1c after 12 weeks of treatment.
Measured: Week 0 to Week 12
Change From Baseline in Body Weight
Change from baseline in body weight after 24 weeks of treatment.
Measured: Week 0 to Week 24
Percentage of Participants With HbA1c Target Value of <7%
Percentage of Participants With HbA1c Target Value of <7% after 24 weeks of treatment.
Measured: Week 0 to Week 24
Percentage of Participants With HbA1c Target Value of <5.7%
Percentage of Participants With HbA1c Target Value of <5.7%after 24 weeks of treatment.
Measured: Week 0 to Week 24
Change From Baseline in Fasting Serum Glucose
Change from baseline in 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.

4 Jul 202530 Apr 2027

First posted14 Jul 2025
Study start4 Jul 2025
Primary completion30 Apr 2027 (estimated)
Study completion30 Apr 2027 (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: 152 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07064486
Sponsor's protocol ID: BGM0504-Ⅲ-T2DM-02-IDN
Status last verified: Oct 2026
First submitted: 11 Jul 2025
Last updated: 13 Oct 2026
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes (T2DM) trials

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 3, Randomized, Open Label Trial Comparing Efficacy and Safety of BGM0504 Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
ClinicalTrials.gov ID: NCT07064486
Acronym / sponsor ID: BGM0504-Ⅲ-T2DM-02-IDN
Conditions: Type 2 Diabetes (T2DM)
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 152 participants (actual)
Lead sponsor: BrightGene Bio-Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
Study start: 4 Jul 2025 (actual)
Primary completion: 30 Apr 2027 (estimated)
Study completion: 30 Apr 2027 (estimated)
First posted: 14 Jul 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.

This trial is conducted in Indonesia. The aim of the trial is to evaluate the efficacy and safety of BGM0504 versus semaglutide as add-on to metformin in patients with type 2 diabetes

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

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.
1 mg Semaglutide	Active comparator	Drug: Semaglutide1 mg semaglutide administered 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
BGM0504Administered SC	Drug	5 mg BGM0504
BGM0504Administered SC	Drug	10 mg BGM0504
SemaglutideAdministered SC	Drug	1 mg Semaglutide

Primary outcome

Change From Baseline in Hemoglobin A1c (HbA1c)
Time frame: Week 0 to Week 24
Change from baseline in HbA1c after 24 weeks of treatment.

5 secondary outcomes

Change From Baseline in Hemoglobin A1c (HbA1c)
Time frame: Week 0 to Week 12
Change From Baseline in Body Weight
Time frame: Week 0 to Week 24
Percentage of Participants With HbA1c Target Value of <7%
Time frame: Week 0 to Week 24
Percentage of Participants With HbA1c Target Value of <5.7%
Time frame: Week 0 to Week 24
Change From Baseline in Fasting Serum Glucose
Time frame: Week 0 to Week 24

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.

Related trials for Type 2 Diabetes (T2DM)

Recruiting
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Not yet recruitingPhase 2
A Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SAL0150 Tablets in Subjects With Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus (T2DM), Type 2 Diabetes
RecruitingPhase 3
A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes
Obesity, Overweight
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An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
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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.

4 sites 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 4 sites in Indonesia.

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 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 4 sites in Indonesia. 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?

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 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 NCT07064486.

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.