Type 2 Diabetes MellitusPhase 3NCT06254014
A Phase 3 Study to Evaluate the Efficacy of JY09 Compared With Placebo in T2DM Patients
A Phase 3 study testing Exendin-4 Fc fusion protein injection in people with Type 2 Diabetes Mellitus, run by Beijing Dongfang Biotech Co., Ltd. at 1 site in China.
Trial summary
The main purpose of this study is to investigate the efficacy and safety of JY09 versus placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled by diet and exercise alone Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Exendin-4 Fc fusion protein injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2024to 30 Jun 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.
- Those who received dietary and exercise interventions for ≥8 weeks prior to screening and who had not received any antidiabetic medications in 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 (V3).
- 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 other hypoglycemic agents within 8 weeks prior to screening or prior to randomization (V4), or those who have used medications that may affect glucose metabolism, such as systemic glucocorticoids (except for inhalation or topical topical use), growth hormones, etc.
- 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.
- Persons who have had a severe trauma or serious infection within 1 month prior to screening or prior to randomization (V4) that may affect glycemic control, and persons who currently have a complicated or refractory urinary or genital tract infection.
- Suffering from any condition at screening or prior to randomization (V4) that may cause hemolysis or red blood cell instability that would interfere with the measurement of HbA1c levels, such as hemolytic anemia.
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- Subjects who have abnormal thyroid function tests at Screening and require medication, or subjects who are being treated with thyroid-related medications whose thyroid function is still not well controlled at Screening.
- Those with any of the following abnormalities on serologic testing at screening:
- 1）Positive human immunodeficiency virus antibodies or syphilis spirochete-specific antibodies; 2）Hepatitis C antibody positive; 3）Hepatitis B virus surface antigen (HBsAg) positive and hepatitis B viral load (HBV-DNA) above the lower limit of laboratory testing (HBV-DNA is added only if HBsAg is positive); 9. The subject has other conditions that, in the judgment of the investigator, make participation in this clinical study inappropriate.
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 Phase 3, Multi-center, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of JY09 in Patients With T2DM Inadequately Controlled by Diet and Exercise Alone
The main purpose of this study is to investigate the efficacy and safety of JY09 versus placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled by diet and exercise alone
Read the detailed description
This study was designed as a multicenter, randomized, double-blind, placebo-parallel 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 (T2DM) who have poor glycemic control after dietary exercise intervention only.
The proposed plan is to enroll 270 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=90 subjects), the 2.4 mg JY09 injection group (n=90 subjects), and the placebo group (n=90 subjects) in a 1:1:1 ratio.
The trial was divided into 4 phases, i.e., a screening period of 2 weeks, a single-blind 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. Total 64 weeks.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Exendin-4 Fc fusion protein injection, Placebo
- Keywords
- T2DM
- 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.
Exendin-4 Fc fusion protein injectionDrug
Also called JY09(1.2mg)
1.2mg, subcutaneous injection in the abdomen, biweekly, 54 weeks of treatment.
Exendin-4 Fc fusion protein injectionDrug
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.
PlaceboDrug
Also called Injection mimetic
0.6 ml, placebo injection, biweekly subcutaneous abdominal injections for 26 weeks (core treatment period), after which placebo was randomized 1:1 to JY09 (1.2 mg) and JY09 (2.4 mg) continued subcutaneous abdominal injections biweekly for 28 weeks (extended treatment period).
| Study group | Role | What they receive |
|---|---|---|
| Exendin-4 Fc fusion protein injection(1.2mg） | Experimental | 1.2mg,Subcutaneous injection in the abdomen,Bi-weekly for 54 weeks. Receives: Drug: Exendin-4 Fc fusion protein injection |
| Exendin-4 Fc fusion protein injection(2.4mg） | 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 |
| placebo(0.6ml） | Placebo comparator | JY09 placebo injection 0.6 ml, biweekly abdominal subcutaneous injection for 26 weeks, followed by randomization in a 1:1 ratio into JY09 (1.2 mg) and JY09 (2.4 mg) for 28 weeks, biweekly subcutaneous injections. Receives: Drug: Placebo |
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.
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 posted12 Feb 2024
- Study start10 Jul 2024
- Primary completion1 May 2026 (estimated)
- Study completion30 Jun 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 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=90 cases), the 2.4 mg JY09 injection group (n=90 cases), and the placebo group (n=90 cases).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Dongfang Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Linong Ji, Doctor, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254014
- Sponsor's protocol ID
- DFBT-JY09-DM-301
- Status last verified
- Sep 2025
- First submitted
- 3 Feb 2024
- Last updated
- 18 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 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multi-center, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of JY09 in Patients With T2DM Inadequately Controlled by Diet and Exercise Alone
- ClinicalTrials.gov ID
- NCT06254014
- Acronym / sponsor ID
- DFBT-JY09-DM-301
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- T2DM
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Beijing Dongfang Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 12 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 main purpose of this study is to investigate the efficacy and safety of JY09 versus placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled by diet and exercise alone
Detailed description
This study was designed as a multicenter, randomized, double-blind, placebo-parallel 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 (T2DM) who have poor glycemic control after dietary exercise intervention only.
The proposed plan is to enroll 270 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=90 subjects), the 2.4 mg JY09 injection group (n=90 subjects), and the placebo group (n=90 subjects) in a 1:1:1 ratio.
The trial was divided into 4 phases, i.e., a screening period of 2 weeks, a single-blind 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. Total 64 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized in a 1:1:1 ratio to the 1.2 mg JY09 injection group (n=90 cases), the 2.4 mg JY09 injection group (n=90 cases), and the placebo group (n=90 cases).
| Arm | Type | Receives |
|---|---|---|
| Exendin-4 Fc fusion protein injection(1.2mg） | Experimental | Drug: Exendin-4 Fc fusion protein injection1.2mg,Subcutaneous injection in the abdomen,Bi-weekly for 54 weeks. |
| Exendin-4 Fc fusion protein injection(2.4mg） | Experimental | Drug: Exendin-4 Fc fusion protein injectionThe 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. |
| placebo(0.6ml） | Placebo comparator | Drug: PlaceboJY09 placebo injection 0.6 ml, biweekly abdominal subcutaneous injection for 26 weeks, followed by randomization in a 1:1 ratio into JY09 (1.2 mg) and JY09 (2.4 mg) for 28 weeks, biweekly subcutaneous injections. |
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.
- Those who received dietary and exercise interventions for ≥8 weeks prior to screening and who had not received any antidiabetic medications in 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 (9 listed)
- People diagnosed with type 1 diabetes or other types of diabetes.
- Those who have used other hypoglycemic agents within 8 weeks prior to screening or prior to randomization (V4), or those who have used medications that may affect glucose metabolism, such as systemic glucocorticoids (except for inhalation or topical topical use), growth hormones, etc.
- 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.
- Persons who have had a severe trauma or serious infection within 1 month prior to screening or prior to randomization (V4) that may affect glycemic control, and persons who currently have a complicated or refractory urinary or genital tract infection.
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 injectionAlso: JY09(1.2mg)1.2mg, subcutaneous injection in the abdomen, biweekly, 54 weeks of treatment. | Drug | Exendin-4 Fc fusion protein injection(1.2mg） |
| Exendin-4 Fc fusion protein injectionAlso: 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） |
| PlaceboAlso: Injection mimetic0.6 ml, placebo injection, biweekly subcutaneous abdominal injections for 26 weeks (core treatment period), after which placebo was randomized 1:1 to JY09 (1.2 mg) and JY09 (2.4 mg) continued subcutaneous abdominal injections biweekly for 28 weeks (extended treatment period). | Drug | placebo(0.6ml） |
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 18 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.
Linong Ji, Doctor principal investigator
Peking University People's 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 in people with Type 2 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 9 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 18 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. 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?
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 18 Sep 2025.