A Study of HS-20094 in Patients With T2DM

NCT06901648 | Completed Phase 2

• 1 other identifier: HS-20094-203
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The change of HbA1c in the patients

  From baseline to week 32

Secondary Outcomes (7)

• The percentage of patients reaching the HbA1c target of ≤ 6.5%

  From baseline to week 32

• The percentage of patients reaching the HbA1c target of<7.0%

  From baseline to week 32

• The change in fasting blood glucose

  From baseline to week 32

• The change in C peptide

  From baseline to week 32

• The change of fasting insulin in the patients

  From baseline to week 32

Study Arms (5)

HS-20094 5mg

EXPERIMENTAL

Drug: HS-20094

HS-20094 10mg

EXPERIMENTAL

Drug: HS-20094

HS-20094 15mg

EXPERIMENTAL

Drug: HS-20094

Dulaglutide 1.5mg

ACTIVE COMPARATOR

Drug: Dulaglutide

Placebo

PLACEBO COMPARATOR

Drug: Palcebo

Interventions

HS-20094 DRUG

Administrated by subcutaneous injection once a week

HS-20094 10mg; HS-20094 15mg; HS-20094 5mg

Dulaglutide DRUG

Administrated by subcutaneous injection once a week

Dulaglutide 1.5mg

Palcebo DRUG

Administrated by subcutaneous injection once a week

Placebo

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 patients 18 to 75 years of age, inclusive
• Patients were diagnosed with T2DM for at least 3 months before screening.
• 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
• Body mass index (BMI）≥ 22 kg/m2.

You may not qualify if:

• Type 1 diabetes, gestational diabetes, monogenic diabetes, secondary diabetes, or undetermined diabetes as assessed by the investigator
• Acute or chronic pancreatitis at any time before screening, or serum lipase/amylase above the upper limit of normal at screening
• 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
• Occurrence of diabetic ketoacidosis, hyperosmolar coma, or lactic acidosis two or more times within 6 months prior to screening
• 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)
• Significant weight change (weight gain or loss ≥5%) within 3 months prior to screening (as reported by the participant)

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Tianjin Medical University General Hospital (Zhu Xianyi Memorial Hospital)

Tianjin, Tianjin Municipality, 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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 30, 2025
• Study Start: February 6, 2024
• Primary Completion: March 7, 2025
• Study Completion: April 9, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

CN (1)