Evaluating JY09 for Type 2 Diabetes Management

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

This study is testing a new injection called JY09 to see if it can help adults with type 2 diabetes better control their blood sugar when diet and exercise aren't enough.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 270 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beijing Dongfang Biotech Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06254014 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial aims to assess the efficacy and safety of JY09, an Exendin-4Fc fusion protein injection, compared to a placebo in adults with type 2 diabetes mellitus (T2DM) who have not achieved adequate glycemic control through diet and exercise alone. The study will enroll 270 participants and utilize a randomized, double-blind, placebo-controlled design, with subjects assigned to either the JY09 injection groups or the placebo group. The trial consists of a 64-week duration, including screening, treatment, and safety follow-up phases.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with poorly controlled T2DM despite dietary and exercise interventions.

Not a fit: Patients who have recently used antidiabetic medications or have HbA1c levels outside the specified range may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide improved glycemic control for patients with type 2 diabetes who struggle with diet and exercise alone.

How similar studies have performed: Previous studies have shown promise with similar approaches in managing type 2 diabetes, indicating potential for success.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing

• Peking University People's Hospital — Beijing, Beijing, China (Recruiting)

Study contacts

• Principal investigator: Linong Ji, Doctor — Peking University People's Hospital
• Study coordinator: Xuefeng Li, Master

Conditions Type 2 Diabetes Mellitus; T2DM