A Study of HS-20094 in Patients With T2DM

Hansoh Pharma

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: HS-20094; Drug: Dulaglutide; Drug: Palcebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06901648

HS-20094-203

Details and patient eligibility

About

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.

Enrollment: 275 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

275 participants in 5 patient groups, including a placebo group

HS-20094 5mg

Experimental group

Treatment:

Drug: HS-20094

HS-20094 10mg

Experimental group

Treatment:

Drug: HS-20094

HS-20094 15mg

Experimental group

Treatment:

Drug: HS-20094

Dulaglutide 1.5mg

Active Comparator group

Treatment:

Drug: Dulaglutide

Placebo

Placebo Comparator group

Treatment:

Drug: Palcebo