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

Not Applicable

Not yet recruiting

• Conditions: Type 2 Diabetes
• Interventions: Drug: HS-20094 Injection; Drug: Dulaglutide Injection

• Registration Number: NCT07156539
• Lead Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-28
• Study First Submitted QC: 2025-08-28
• Last Update Submitted: 2025-08-28
• Study First Posted: 2025-09-05
• Last Update Posted: 2025-09-05
• Study Start: 2025-09-30
• Primary Completion: 2027-03-30
• Study Completion: 2027-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 546

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group A	HS-20094 Injection	HS-20094-low dose
Treatment Group B	HS-20094 Injection	HS-20094-high dose
Treatment Group C	Dulaglutide Injection	Dulaglutide -1.5mg

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	Week 0 to Week 44	Change from baseline in HbA1c after 44 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with HbA1c<7.0% and ≤6.5%	Week 0 to Week 52	Proportion of subjects with HbA1c\<7.0% and ≤6.5% after 52 weeks of treatment
Change in FPG	Week 0 to Week 52	Change from baseline in FPG after 52 weeks of treatment
Change in body weight	Week 0 to Week 52	Change from baseline in Change in body weight after 52 weeks of treatment
Proportion of subjects with weight loss ≥5% and ≥10%	Week 0 to Week 52	Proportion of subjects with weight loss ≥5% and ≥10% after 52 weeks of treatment
Change in HbA1c	Week 0 to Week 52	Change from baseline in HbA1c after 52 weeks of treatment
Incidence and severity of adverse events	Week 0 to Week 52+4 weeks follow-up	Severity (mild, moderate and severe) is assessed by investigator

Trial Locations

Locations (2)

Shandong Provincial Hospital; 🇨🇳 Jinan, Shandong, China

Tianjin Medical University General Hospital (Zhu Xianyi Memorial Hospital); 🇨🇳 Tianjin, Tianjn, China