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Clinical Trials in China / NCT07156539
Starting soon Phase 3

A Phase 3 Study of HS-20094 in Patients With T2DM

NCT07156539 · tracked via the Priya Life Science China tracker
Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Phase
Phase 3
Started
2025-09-30
Last updated
2025-09-05

Condition(s) studied

Type 2 Diabetes

Investigational drug(s) / intervention(s)

HS-20094 InjectionDulaglutide Injection →

HS-20094 Injection: HS-20094 injected subcutaneously once weekly

Dulaglutide Injection: Dulaglutide injected subcutaneously once weekly

Study summary

The study is being conducted to evaluate the efficacy and safety of HS-20094 once weekly (QW) in subjects with type 2 diabetes mellitus not adequately controlled with metformin monotherapy or in combination with SGLT2 inhibitors compared to Dulaglutide QW for 44 weeks and 52 weeks.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Males and females, Age ≥18 years at the time of signing informed consent. 2. Stable daily dose(s) for ≥90 days prior to screening of : 1) Any metformin formulations ≥1500 mg daily or maximum tolerated (≥1000mg daily). 2) Any metformin formulations ≥1500 mg daily or maximum tolerated (≥1000mg daily) with one type of SGLT-2 inhibitors; 3. Glycated hemoglobin was 7.5% ≤HbA1c ≤11.0%; 4. BMI ≥ 23 kg/m2. Exclusion Criteria: 1. Uncontrollable hypertension(with or without antihypertensive treatment) : systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening. 2. Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes. 3. History of significant hematological disorders (e.g., sickle cell disease, hemolytic anemia, myelodysplastic syndrome, etc.) or other conditions causing hemolysis or instability of red blood cells (e.g., malaria, hypersplenism, etc.). 4. Presence of an endocrine disorder or history that may significantly affect bady weight(e.g., Cushing's syndrome, hypothyroidism or hyperthyroidism, except hypothyroidism if thyroid hormone replacement dose has been stable for at least 6 months) ; 5. Severe infection, severe trauma, or moderate-to-major surgery within 4 weeks before screening. 6. Participated in clinical trials of any drug or medical device within 12 weeks prior to screening, and participation in clinical trials is defined as signing informed consent and using investigational drugs (including placebo) or investigational medical devices; Or is still in the trial drug within 5 half-lives (whichever is Longer).

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Shandong Provincial Hospital Jinan Shandong
Tianjin Medical University General Hospital (Zhu Xianyi Memorial Hospital) Tianjin Tianjn

More Jiangsu Hansoh Pharmaceutical Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07156539 on ClinicalTrials.gov ↗ ← All trials in China