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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
Lead sponsor
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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 endpointsHbA1c
Time frame:Baseline, Week 26
HbA1c, change
change from baseline, improvement
LOINC 4548-4
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
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
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
fasting insulin
Time frame:Baseline, Week 14,Week 26,Week 54
change from baseline, improvement
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 endpointblood pressure
Time frame:Baseline,Week 26,Week 54
change from baseline, improvement
Patient-reported / QoL
1 endpointHealth Survey Short Form (SF-36)
Time frame:Baseline,Week 26,Week 54
SF-36 total
change from baseline, improvement
Provenance
Sources
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.