A Study of HS-20094 in Patients With T2DM

Phase 2

Recruiting

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

• Registration Number: NCT06901648
• Lead Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-23
• Status Verified: 2025-02
• Study First Submitted: 2025-02-25
• Study First Submitted QC: 2025-03-28
• Last Update Submitted: 2025-03-28
• Study First Posted: 2025-03-30
• Last Update Posted: 2025-03-30
• Primary Completion: 2025-08-14
• Study Completion: 2025-09-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 270

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HS-20094 5mg	HS-20094	-
HS-20094 10mg	HS-20094	-
HS-20094 15mg	HS-20094	-
Dulaglutide 1.5mg	Dulaglutide	-
Placebo	Palcebo	-

Primary Outcome Measures

Name	Time	Method
The change of HbA1c in the patients	From baseline to week 32

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

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