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Active not recruitingPhase 3

A Phase 3 Study to Evaluate the Efficacy of JY09 Compared With Placebo in T2DM Patients

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

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

270

actual

Study population

Type 2 diabetes

Key I/E criterion

BMI 18.5-35

Primary endpoint

HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06254014
Org study IDDFBT-JY09-DM-301

Timeline

Milestones

Study first posted2024-02-12actual
Study start2024-07-10actual
Last update posted2025-09-18actual
Primary completion2026-05-01estimated
Study completion2026-06-30estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Male or female subjects ≥18 years of age and ≤75 years of age at the time of signing the informed consent form.

2. 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.

3. 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.

4. HbA1c ≥7.5% and ≤11.0% at screening (local laboratory) and HbA1c ≥7.0% and ≤10.5% before randomization (V3) (central laboratory).

5. FPG 13.9 mmol/L at screening (local laboratory) and FPG 13.9 mmol/L before randomization (V3) (central laboratory).

6. Body mass index (BMI) ≥18.5 kg/m2 and ≤35.0 kg/m2 at screening and before randomization (V3).

7. Able to understand and willing to sign a written informed consent form (ICF) and comply with the study protocol.

Exclusion criteria

1. People diagnosed with type 1 diabetes or other types of diabetes.

2. 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.

3. Acute complications of diabetes, such as diabetic ketoacidosis or hyperglycemic hyperosmolar state, within 6 months prior to screening or prior to randomization.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
6
Cardiometabolic biomarkers
1
Patient-reported / QoL
1

Glycemic / diabetes

6 endpoints
Primary/protocol endpoint

HbA1c

Time frame:Baseline, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

The proportion of HbA1c <6.5% and <7%

Time frame:Baseline, Week 26,Week 54

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

HbA1c

Time frame:Baseline, Week 6,Week 10,Week 14,Week 20,Week 38,Week 54

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

fasting plasma glucose (FPG)

Time frame:Baseline, Week 6,Week 10,Week 14,Week 20,Week 38,Week 54

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

fasting insulin

Time frame:Baseline, Week 14,Week 26,Week 54

change from baseline, improvement

Secondary/protocol endpoint

Homeostatic Model Assessment of Insulin Resistance(HOMA-IR)

Time frame:Baseline,Week 26,Week 54

HOMA-IR (insulin sensitivity)

percent change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

blood pressure

Time frame:Baseline,Week 26,Week 54

change from baseline, improvement

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Health Survey Short Form (SF-36)

Time frame:Baseline,Week 26,Week 54

SF-36 total

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.