A Study of HS-20094 in Patients With T2DM

Efficacy and Safety of HS-20094, a Novel Dual GIP and GLP-1 Receptor Agonist, in Patients With Type 2 Diabetes: a Randomized, Placebo-controlled and Active Comparator-controlled Phase 2 Trial

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: HS-20094; Drug: Dulaglutide; Drug: Palcebo

• Study Type: Interventional
• Enrollment (Actual): 275
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China
      • Tianjin Medical University General Hospital (Zhu Xianyi Memorial Hospital)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Palcebo; Administrated by subcutaneous injection once a week
Experimental: HS-20094 5mg	Drug: HS-20094; Administrated by subcutaneous injection once a week
Experimental: HS-20094 10mg	Drug: HS-20094; Administrated by subcutaneous injection once a week
Experimental: HS-20094 15mg	Drug: HS-20094; Administrated by subcutaneous injection once a week
Active Comparator: Dulaglutide 1.5mg	Drug: Dulaglutide; Administrated by subcutaneous injection once a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The change of HbA1c in the patients	From baseline to week 32

Secondary Outcome Measures

Outcome Measure	Time Frame
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
The change in body weight	From baseline to week 32
The percentage of patients with 5% or greater body weight loss	From baseline to week 32

Collaborators and Investigators

• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2024
• Primary Completion (Actual): March 7, 2025
• Study Completion (Actual): April 9, 2025

Study Registration Dates

• First Submitted: February 25, 2025
• First Submitted That Met QC Criteria: March 28, 2025
• First Posted (Actual): March 30, 2025

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucagon-Like Peptide-1 Receptor Agonists; Physiological Effects of Drugs; Hypoglycemic Agents; Dulaglutide
• Other Study ID Numbers: HS-20094-203

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No