Type2 Diabetes MellitusPhase 3NCT06257966
A Phase 3 Study to Evaluate the Efficacy of JY09 Compared With Dulaglutide in Combination Therapy Diabetes Mellitus Type 2 Patients With Metformin
A Phase 3 study testing Exendin-4 Fc fusion protein injection(1.2mg）, Exendin-4 Fc fusion protein injection（2.4mg） and Dulaglutide in people with Type2 Diabetes Mellitus, run by Beijing Dongfang Biotech Co., Ltd. at 1 site in China.
Trial summary
The aim of the study is to compare the efficacy and safety of two JY09 doses versus dulaglutide as add-on therapy to metformin in participants with type 2 diabetes mellitus (T2DM) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type2 Diabetes Mellitus
- What is being tested?
- Exendin-4 Fc fusion protein injection(1.2mg）, Exendin-4 Fc fusion protein injection（2.4mg） and Dulaglutide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 17 Jul 2024to 30 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
- Male or female subjects ≥18 years of age and ≤75 years of age at the time of signing the informed consent form.
- Those who meet the World Health Organization（WHO）1999 diagnostic criteria for type 2 diabetes mellitus and the WHO Recommendations for the Use of Glycosylated Haemoglobin (HbA1c) for Diagnosis (2011) supplemental diagnostic criteria for a diagnosis of T2DM for ≥ 12 weeks.
- Received a stable dose of metformin monotherapy with a metformin dose ≥1500 mg/day or a maximally tolerated dose (<1500 mg/day but ≥1000 mg/day) on the basis of dietary and exercise interventions during the 8 weeks prior to screening.
- HbA1c ≥7.5% and ≤11.0% at screening (local laboratory) and HbA1c ≥7.0% and ≤10.5% before randomization (V3) (central laboratory).
- FPG 13.9 mmol/L at screening (local laboratory) and FPG 13.9 mmol/L before randomization (V3) (central laboratory).
- Body mass index (BMI) ≥18.5 kg/m2 and ≤35.0 kg/m2 at screening and before randomization (V4).
- Able to understand and willing to sign a written informed consent form (ICF) and comply with the study protocol.
Who cannot join
- People diagnosed with type 1 diabetes or other types of diabetes.
- Those who have used glucose-lowering drugs other than metformin within 8 weeks prior to screening or prior to randomization (V4), or those who have used drugs that may affect glucose metabolism, such as systemic glucocorticosteroids (except for inhalation or topical topical use) and growth hormone.
- Those who have used glucose-dependent insulinotropic polypeptide (GIP) and/or glucagon-like peptide-1 (GLP-1) receptor agonists (including single-target, multi-target agonists, and insulin-containing GLP-1 combinations) within 3 months prior to screening.
- More than 14 days of continuous insulin use in the 6 months prior to screening.
- Acute complications of diabetes such as diabetic ketoacidosis or hyperglycemic hyperosmolar state within 6 months prior to screening or prior to randomization .
- Severe chronic complications of diabetes mellitus (e.g., proliferative diabetic retinopathy, severe diabetic neuropathy, diabetic foot, etc.) within 6 months prior to screening, which are assessed by the investigator to be unsuitable for participation in this clinical study.
- Individuals who have had severe gastrointestinal disease (e.g., active ulcer, gastroparesis, pyloric obstruction, inflammatory bowel disease, etc.) or have undergone gastrointestinal surgery within 6 months prior to screening or prior to randomization or who have been using long-term medications for chronic gastrointestinal disease that have a direct effect on gastrointestinal motility are not suitable for participation in this clinical study, as assessed by the investigator.
- Other conditions that, in the judgment of the investigator, make the subject unsuitable for participation in this clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: A Phase 3, Multi-center, Open-label, Randomized Study to Evaluate the Efficacy and Safety of JY09 Versus Dulaglutide in Patients With T2DM Inadequately Controlled by Metformin
The aim of the study is to compare the efficacy and safety of two JY09 doses versus dulaglutide as add-on therapy to metformin in participants with type 2 diabetes mellitus (T2DM)
Read the detailed description
This study was designed as a multicenter, randomized, open, parallel, positively controlled Phase III clinical study to evaluate the efficacy and safety of Exendin-4Fc fusion protein (JY09) injection in adult subjects with type 2 diabetes mellitus who have poor glycemic control after metformin treatment only.
The proposed plan is to enroll 600 subjects with T2DM, using stratified block group randomization with the stratification factor being baseline HbA1c (≤8.5% or >8.5%), and randomly assign them to the 1.2 mg JY09 injection group (n=200 subjects), 2.4 mg JY09 injection group (n=200 subjects) and dulaglutide injection group (n=200 subjects) in a 1:1:1 ratio.
The trial was divided into 4 phases, i.e., a screening period of 2 weeks, an introduction period of 4 weeks, a treatment period of 54 weeks (26 weeks for the core treatment period and 28 weeks for the extended treatment period), and a safety follow-up period of 4 weeks. A total of 64 weeks.
- Conditions
- Type2 Diabetes Mellitus
- Being tested
- Exendin-4 Fc fusion protein injection(1.2mg）, Exendin-4 Fc fusion protein injection（2.4mg）, Dulaglutide, Metformin
- Keywords
- T2DM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exendin-4 Fc fusion protein injection(1.2mg）Drug
Also called JY09(1.2mg)
1.2mg, subcutaneous injection in the abdomen, biweekly, 54 weeks of treatment.
Exendin-4 Fc fusion protein injection（2.4mg）Drug
Also called JY09(2.4mg)
The first dose of 1.2 mg was administered subcutaneously in the abdomen, and after two weeks, the dose was adjusted to 2.4 mg, followed by a continuation of treatment for 52 weeks.
DulaglutideDrug
1.5 mg dulaglutide injection subcutaneously once a week for 54 weeks.
MetforminDrug
Metformin hydrochloride tablets, oral administration, 54 weeks of treatment
| Study group | Role | What they receive |
|---|---|---|
| Exendin-4 Fc fusion protein injection(1.2mg）+Metformin | Experimental | 1.2mg,Subcutaneous injection in the abdomen,Bi-weekly for 54 weeks. Receives: Drug: Exendin-4 Fc fusion protein injection(1.2mg）; Drug: Metformin |
| Exendin-4 Fc fusion protein injection(2.4mg）+Metformin | Experimental | The first dose of 1.2 mg of JY09 injection was administered, the dose was adjusted to 2.4 mg after two weeks, after which 2.4 mg was maintained to continue subcutaneous injection in the abdomen, bi-weekly treatment for 52 weeks. Receives: Drug: Exendin-4 Fc fusion protein injection（2.4mg）; Drug: Metformin |
| Dulaglutide+Metformin | Active comparator | 1.5 mg dulaglutide injection subcutaneously once a week for 26 weeks. Receives: Drug: Dulaglutide; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Change in glycated hemoglobin (HbA1c) values relative to baseline after 26 weeks of treatment
Measured: Baseline, Week 26
Secondary outcomes (7)
The proportion of HbA1c <6.5% and <7%
Proportion of subjects with HbA1c <7% and HbA1c <6.5% after 26 and 54 weeks of treatment
Measured: Baseline, Week 26,Week 54
HbA1c
Change in HbA1c relative to baseline after 6, 10, 14, 20, 38, and 54 weeks of treatment.
Measured: Baseline, Week 6,Week 10,Week 14,Week 20,Week 38,Week 54
fasting plasma glucose (FPG)
Change in fasting plasma glucose (FPG) relative to baseline after 6, 10, 14, 20, 38, and 54 weeks of treatment.
Measured: Baseline, Week 6,Week 10,Week 14,Week 20,Week 38,Week 54
fasting insulin
Change in fasting insulin relative to baseline after 14, 26, and 54 weeks of treatment.
Measured: Baseline, Week 14,Week 26,Week 54
Homeostatic Model Assessment of Insulin Resistance(HOMA-IR)
Change in HOMA-IR relative to baseline after 26 and 54 weeks of treatment.
Measured: Baseline,Week 26,Week 54
Health Survey Short Form (SF-36)
Value of change in Health Survey Short Form (SF-36) scores relative to baseline after 26 and 54 weeks of treatment.
Measured: Baseline,Week 26,Week 54
blood pressure
Change in blood pressure (sitting) relative to baseline after 26 and 54 weeks of treatment.
The blood pressure includes systolic and diastolic blood pressure.
Measured: Baseline,Week 26,Week 54
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start17 Jul 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 Diabetes MellitusStudies 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
- Model description
- Randomized in a 1:1:1 ratio to the 1.2 mg JY09 injection group (n=200 cases), the 2.4 mg JY09 injection group (n=200 cases), and the dulaglutide injection group (n=200 cases).
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Dongfang Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Junqing Zhang, Doctor, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257966
- Sponsor's protocol ID
- DFBT-JY09-DM-302
- Status last verified
- Sep 2025
- First submitted
- 6 Feb 2024
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multi-center, Open-label, Randomized Study to Evaluate the Efficacy and Safety of JY09 Versus Dulaglutide in Patients With T2DM Inadequately Controlled by Metformin
- ClinicalTrials.gov ID
- NCT06257966
- Acronym / sponsor ID
- DFBT-JY09-DM-302
- Conditions
- Type2 Diabetes Mellitus
- Keywords
- T2DM
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Beijing Dongfang Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 14 Feb 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.
The aim of the study is to compare the efficacy and safety of two JY09 doses versus dulaglutide as add-on therapy to metformin in participants with type 2 diabetes mellitus (T2DM)
Detailed description
This study was designed as a multicenter, randomized, open, parallel, positively controlled Phase III clinical study to evaluate the efficacy and safety of Exendin-4Fc fusion protein (JY09) injection in adult subjects with type 2 diabetes mellitus who have poor glycemic control after metformin treatment only.
The proposed plan is to enroll 600 subjects with T2DM, using stratified block group randomization with the stratification factor being baseline HbA1c (≤8.5% or >8.5%), and randomly assign them to the 1.2 mg JY09 injection group (n=200 subjects), 2.4 mg JY09 injection group (n=200 subjects) and dulaglutide injection group (n=200 subjects) in a 1:1:1 ratio.
The trial was divided into 4 phases, i.e., a screening period of 2 weeks, an introduction period of 4 weeks, a treatment period of 54 weeks (26 weeks for the core treatment period and 28 weeks for the extended treatment period), and a safety follow-up period of 4 weeks. A total of 64 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized in a 1:1:1 ratio to the 1.2 mg JY09 injection group (n=200 cases), the 2.4 mg JY09 injection group (n=200 cases), and the dulaglutide injection group (n=200 cases).
| Arm | Type | Receives |
|---|---|---|
| Exendin-4 Fc fusion protein injection(1.2mg）+Metformin | Experimental | Drug: Exendin-4 Fc fusion protein injection(1.2mg）, Drug: Metformin1.2mg,Subcutaneous injection in the abdomen,Bi-weekly for 54 weeks. |
| Exendin-4 Fc fusion protein injection(2.4mg）+Metformin | Experimental | Drug: Exendin-4 Fc fusion protein injection（2.4mg）, Drug: MetforminThe first dose of 1.2 mg of JY09 injection was administered, the dose was adjusted to 2.4 mg after two weeks, after which 2.4 mg was maintained to continue subcutaneous injection in the abdomen, bi-weekly treatment for 52 weeks. |
| Dulaglutide+Metformin | Active comparator | Drug: Dulaglutide, Drug: Metformin1.5 mg dulaglutide injection subcutaneously once a week for 26 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female subjects ≥18 years of age and ≤75 years of age at the time of signing the informed consent form.
- Those who meet the World Health Organization（WHO）1999 diagnostic criteria for type 2 diabetes mellitus and the WHO Recommendations for the Use of Glycosylated Haemoglobin (HbA1c) for Diagnosis (2011) supplemental diagnostic criteria for a diagnosis of T2DM for ≥ 12 weeks.
- Received a stable dose of metformin monotherapy with a metformin dose ≥1500 mg/day or a maximally tolerated dose (<1500 mg/day but ≥1000 mg/day) on the basis of dietary and exercise interventions during the 8 weeks prior to screening.
- HbA1c ≥7.5% and ≤11.0% at screening (local laboratory) and HbA1c ≥7.0% and ≤10.5% before randomization (V3) (central laboratory).
- FPG 13.9 mmol/L at screening (local laboratory) and FPG 13.9 mmol/L before randomization (V3) (central laboratory).
Key exclusion criteria (8 listed)
- People diagnosed with type 1 diabetes or other types of diabetes.
- Those who have used glucose-lowering drugs other than metformin within 8 weeks prior to screening or prior to randomization (V4), or those who have used drugs that may affect glucose metabolism, such as systemic glucocorticosteroids (except for inhalation or topical topical use) and growth hormone.
- Those who have used glucose-dependent insulinotropic polypeptide (GIP) and/or glucagon-like peptide-1 (GLP-1) receptor agonists (including single-target, multi-target agonists, and insulin-containing GLP-1 combinations) within 3 months prior to screening.
- More than 14 days of continuous insulin use in the 6 months prior to screening.
- Acute complications of diabetes such as diabetic ketoacidosis or hyperglycemic hyperosmolar state within 6 months prior to screening or prior to randomization .
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 |
|---|---|---|
| Exendin-4 Fc fusion protein injection(1.2mg）Also: JY09(1.2mg)1.2mg, subcutaneous injection in the abdomen, biweekly, 54 weeks of treatment. | Drug | Exendin-4 Fc fusion protein injection(1.2mg）+Metformin |
| Exendin-4 Fc fusion protein injection（2.4mg）Also: JY09(2.4mg)The first dose of 1.2 mg was administered subcutaneously in the abdomen, and after two weeks, the dose was adjusted to 2.4 mg, followed by a continuation of treatment for 52 weeks. | Drug | Exendin-4 Fc fusion protein injection(2.4mg）+Metformin |
| Dulaglutide1.5 mg dulaglutide injection subcutaneously once a week for 54 weeks. | Drug | Dulaglutide+Metformin |
| MetforminMetformin hydrochloride tablets, oral administration, 54 weeks of treatment | Drug | Dulaglutide+Metformin, Exendin-4 Fc fusion protein injection(1.2mg）+Metformin, Exendin-4 Fc fusion protein injection(2.4mg）+Metformin |
Primary outcome
HbA1c
Time frame: Baseline, Week 26
Change in glycated hemoglobin (HbA1c) values relative to baseline after 26 weeks of treatment
7 secondary outcomes
The proportion of HbA1c <6.5% and <7%
Time frame: Baseline, Week 26,Week 54
HbA1c
Time frame: Baseline, Week 6,Week 10,Week 14,Week 20,Week 38,Week 54
fasting plasma glucose (FPG)
Time frame: Baseline, Week 6,Week 10,Week 14,Week 20,Week 38,Week 54
fasting insulin
Time frame: Baseline, Week 14,Week 26,Week 54
Homeostatic Model Assessment of Insulin Resistance(HOMA-IR)
Time frame: Baseline,Week 26,Week 54
Health Survey Short Form (SF-36)
Time frame: Baseline,Week 26,Week 54
blood pressure
Time frame: Baseline,Week 26,Week 54
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 17 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Junqing Zhang, Doctor principal investigator
Peking University First Hospital
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 Exendin-4 Fc fusion protein injection(1.2mg）, Exendin-4 Fc fusion protein injection（2.4mg） and Dulaglutide in people with Type2 Diabetes Mellitus, run by Beijing Dongfang Biotech 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 7 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 17 Sep 2025. 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?
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?
HbA1c (time frame: Baseline, Week 26). 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 17 Sep 2025.