A Study of HS-20094 in Patients With T2DM

NCT ID: NCT06901648

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 275 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-06
• Study Completion Date: 2025-04-09

Brief Summary

This is a 32-week, phase 2, randomized study, HS-20094 and placebo were double-blind, dulaglutide was open-label. Adults with T2D inadequately controlled with diet and exercise alone or with stable metformin, an HbA1c (glycated hemoglobin) ≥53 to ≤91 mmol/mol (≥7.0 % to≤10.5 %) were randomly assigned to receive 5 mg HS-20094, 10 mg HS-20094, 15 mg HS-20094, placebo, or 1.5 mg dulaglutide subcutaneously for 32 weeks. The primary endpoint was change in HbA1C from baseline to 32 weeks, and secondary endpoints included change in fasting glucose, body weight and several additional measures relevant for cardiovascular risks.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

HS-20094 5mg

Group Type: EXPERIMENTAL

HS-20094

Intervention Type: DRUG

Administrated by subcutaneous injection once a week

HS-20094 10mg

Group Type: EXPERIMENTAL

HS-20094

Intervention Type: DRUG

Administrated by subcutaneous injection once a week

HS-20094 15mg

Group Type: EXPERIMENTAL

HS-20094

Intervention Type: DRUG

Administrated by subcutaneous injection once a week

Dulaglutide 1.5mg

Group Type: ACTIVE_COMPARATOR

Dulaglutide

Intervention Type: DRUG

Administrated by subcutaneous injection once a week

Placebo

Group Type: PLACEBO_COMPARATOR

Palcebo

Intervention Type: DRUG

Administrated by subcutaneous injection once a week

Interventions

HS-20094

Administrated by subcutaneous injection once a week

Intervention Type: DRUG

Dulaglutide

Administrated by subcutaneous injection once a week

Intervention Type: DRUG

Palcebo

Administrated by subcutaneous injection once a week

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female patients 18 to 75 years of age, inclusive

2. Patients were diagnosed with T2DM for at least 3 months before screening.

3. Have an HbA1c value at screening of ≥7.0% and ≤10.5% and treated with diet and exercise alone or a stable dose of metformin (either immediate release or extended release, ≥1000mg/day and not more than the locally approved dose) for at least 2 months prior to screening

4. Body mass index (BMI）≥ 22 kg/m2.

Exclusion Criteria

1. Type 1 diabetes, gestational diabetes, monogenic diabetes, secondary diabetes, or undetermined diabetes as assessed by the investigator

2. Acute or chronic pancreatitis at any time before screening, or serum lipase/amylase above the upper limit of normal at screening

3. A history of grade 3 hypoglycemia (hypoglycemia with a serious event of consciousness and/or physical alteration requiring assistance from another person for recovery) within 6 months before screening

4. Occurrence of diabetic ketoacidosis, hyperosmolar coma, or lactic acidosis two or more times within 6 months prior to screening

5. Occurrence of any of the following events within 6 months prior to screening: acute myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention (excluding diagnostic angiography), transient ischemic attack, cerebrovascular accident, decompensated congestive heart failure, or Class III or IV heart failure (NYHA classification)

6. Significant weight change (weight gain or loss ≥5%) within 3 months prior to screening (as reported by the participant)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Hansoh Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tianjin Medical University General Hospital (Zhu Xianyi Memorial Hospital)

Tianjin, Tianjin Municipality, China

Countries

China

Other Identifiers

HS-20094-203

Identifier Type: -

Identifier Source: org_study_id