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

NCT06254014 | Active Not Recruiting Phase 3

• 1 other identifier: DFBT-JY09-DM-301
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Type 2 Diabetes Mellitus

Keywords

T2DM

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Change in glycated hemoglobin (HbA1c) values relative to baseline after 26 weeks of treatment.

  Baseline, Week 26

Secondary Outcomes (7)

• The proportion of HbA1c <6.5% and <7%

  Baseline, Week 26,Week 54

• HbA1c

  Baseline, Week 6,Week 10,Week 14,Week 20,Week 38,Week 54

• fasting plasma glucose (FPG)

  Baseline, Week 6,Week 10,Week 14,Week 20,Week 38,Week 54

• fasting insulin

  Baseline, Week 14,Week 26,Week 54

• Homeostatic Model Assessment of Insulin Resistance(HOMA-IR)

  Baseline,Week 26,Week 54

Study Arms (3)

Exendin-4 Fc fusion protein injection(1.2mg）

EXPERIMENTAL

1.2mg,Subcutaneous injection in the abdomen,Bi-weekly for 54 weeks.

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.

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.

Drug: Placebo

Interventions

Exendin-4 Fc fusion protein injection DRUG

1.2mg, subcutaneous injection in the abdomen, biweekly, 54 weeks of treatment.

Also known as: JY09(1.2mg)

Exendin-4 Fc fusion protein injection(1.2mg）

Placebo DRUG

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).

Also known as: Injection mimetic

placebo(0.6ml）

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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:
• ）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.

Sponsors & Collaborators

• Beijing Dongfang Biotech Co., Ltd.: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Linong Ji, Doctor

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study uses a double-blind technique, which means that neither the investigator nor the subject knows what drug is being used. The sponsor will provide the study drug and the control drug, ensuring that the placebo shape, color, and weight are identical to the study drug.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: February 3, 2024
• First Posted: February 12, 2024
• Study Start: July 10, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)