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

NCT07156539 | Not Yet Recruiting Phase 3

• 1 other identifier: HS-20094-303
• Study Type: interventional
• Target: 546
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  Change from baseline in HbA1c after 44 weeks of treatment

  Week 0 to Week 44

Secondary Outcomes (10)

• Proportion of subjects with HbA1c<7.0% and ≤6.5%

  Week 0 to Week 44

• Change in FPG

  Week 0 to Week 44

• Change in body weight

  Week 0 to Week 44

• Proportion of subjects with weight loss ≥5% and ≥10%

  Week 0 to Week 44.

• Change in HbA1c

  Week 0 to Week 52

Study Arms (3)

Treatment Group A

EXPERIMENTAL

HS-20094-low dose

Drug: HS-20094 Injection

Treatment Group B

EXPERIMENTAL

HS-20094-high dose

Drug: HS-20094 Injection

Treatment Group C

ACTIVE COMPARATOR

Dulaglutide -1.5mg

Drug: Dulaglutide Injection

Interventions

HS-20094 Injection DRUG

HS-20094 injected subcutaneously once weekly

Treatment Group A; Treatment Group B

Dulaglutide Injection DRUG

Dulaglutide injected subcutaneously once weekly

Treatment Group C

Eligibility Criteria

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

You may qualify if:

• Males and females, Age ≥18 years at the time of signing informed consent.
• 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;
• Glycated hemoglobin was 7.5% ≤HbA1c ≤11.0%;
• BMI ≥ 23 kg/m2.

You may not qualify if:

• Uncontrollable hypertension(with or without antihypertensive treatment) : systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening.
• Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
• 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.).
• 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) ；
• Severe infection, severe trauma, or moderate-to-major surgery within 4 weeks before screening.
• 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).

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (2)

Shandong Provincial Hospital

Jinan, Shandong, China

Location

Tianjin Medical University General Hospital (Zhu Xianyi Memorial Hospital)

Tianjin, Tianjn, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dulaglutide

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 5, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: September 5, 2025

Record last verified: 2025-08

Locations

CN (2)