A Study of HS-20094 in T2DM Participants

NCT ID: NCT06118008

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-31
• Study Completion Date: 2024-01-04

Brief Summary

This is a randomized, placebo and active-control, multiple-dose, phase IIa trial. Patients were randomly assigned to receive HS-20094 (12 patients), placebo (3 patients), or active control drug Semaglutide injection (3 patients) in a 4:1:1 ratio to each of four dose cohorts of 5 mg, 10 mg, 15 mg, and 20 mg. HS-20094 and placebo were administered in a double-blind design by subcutaneous injection once a week for a total of four times, and the dose was gradually increased weekly (2.5-2.5-5-5 mg, 5-510-10 mg, 5-10-15-15 mg, 5-10-15-20 mg). The active control drug semaglutide was administered by open-label, titrated subcutaneous injection once a week for a total of four times, and the dose was increased gradually every week until 1.0 mg (0.25-0.5-0.5-1.0 mg). The primary study objective was to 1) Evaluate the safety and tolerability of multiple subcutaneous injections of HS-20094 in subjects with type 2 diabetes mellitus (T2DM) with or without overweight or obesity;2) Evaluate the pharmacokinetics, pharmacodynamics and immunogenicity of multiple subcutaneous injections of HS-20094.

Conditions

Type 2 Diabetes

Study Design

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

Study Groups

HS-20094 5mg

Drug: HS-20094 Administrated by subcutaneous injection

Drug: Placebo Administrated by subcutaneous injection

Drug: Semaglutide Administrated by subcutaneous injection

Group Type: EXPERIMENTAL

HS-20094 5mg

Intervention Type: DRUG

Administrated by subcutaneous injection

HS-20094 10mg

Drug: HS-20094 Administrated by subcutaneous injection

Drug: Placebo Administrated by subcutaneous injection

Drug: Semaglutide Administrated by subcutaneous injection

Group Type: EXPERIMENTAL

HS-20094 10mg

Intervention Type: DRUG

Administrated by subcutaneous injection

HS-20094 15mg

Drug: HS-20094 Administrated by subcutaneous injection

Drug: Placebo Administrated by subcutaneous injection

Drug: Semaglutide Administrated by subcutaneous injection

Group Type: EXPERIMENTAL

HS-20094 15mg

Intervention Type: DRUG

Administrated by subcutaneous injection

HS-20094 20mg

Drug: HS-20094 Administrated by subcutaneous injection

Drug: Placebo Administrated by subcutaneous injection

Drug: Semaglutide Administrated by subcutaneous injection

Group Type: EXPERIMENTAL

HS-20094 20mg

Intervention Type: DRUG

Administrated by subcutaneous injection

Interventions

HS-20094 5mg

Administrated by subcutaneous injection

Intervention Type: DRUG

HS-20094 10mg

Administrated by subcutaneous injection

Intervention Type: DRUG

HS-20094 15mg

Administrated by subcutaneous injection

Intervention Type: DRUG

HS-20094 20mg

Administrated by subcutaneous injection

Intervention Type: DRUG

Other Intervention Names

HS-20094 injection 5mg; HS-20094 injection 10mg; HS-20094 injection 15mg; HS-20094 injection 20mg

Eligibility Criteria

Inclusion Criteria

• Male or female subjects,20-65 years of age at the time of signing informed consent.
• Type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit.
• Treated with conventional lifestyle intervention and stable treatment with metformin ( ≥ 1000 mg/day) at least 3 months prior to screening HbA1c 7.5-10%(both inclusive)at screening visit.

Exclusion Criteria

• A history of type 1 diabetes, specific diabetes, or secondary diabetes.
• Presence of-clinically significant lab or ECG results that may affect the evaluation of the efficacy or safety of the study drug at screening visit.
• 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 2 hypoglycemia(blood glucose 3.0 mmol/L)or 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.
• Diabetid ketoacidosis or hyperosmolar coma or lactic acidosis requiring hospitalization occurred within 6 months before screening.
• Severe infection such as diabetic foot infection, pneumonia, or sepsis within 30 days before screening.
• Uncontrollable hypertension.
• History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening.
• Any organ-system malignancies developed within 5 years except for cured local basal cell carcinoma of the skin and carcinoma in situ of the cervix.
• Pregnant or lactating woman.
• In the investigator's judgment, there were circumstances that affected subject safety or otherwise interfered with the evaluation of results.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Hansoh Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University First Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

HS-20094-201

Identifier Type: -

Identifier Source: org_study_id