A Study of HS-20094 in T2DM Participants

A Multiple-dose, Randomized, Double-blind, Placebo and Positive Controlled Phase IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HS-20094 in Subjects With Type 2 Diabetes.

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: HS-20094 5mg; Drug: HS-20094 10mg; Drug: HS-20094 15mg; Drug: HS-20094 20mg

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yimin Cui, Doctor; Phone Number: 010 66110802; Email: cuiymzy@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Peking University First Hospital

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HS-20094 5mg; Drug: HS-20094 Administrated by subcutaneous injection Drug: Placebo Administrated by subcutaneous injection Drug: Semaglutide Administrated by subcutaneous injection	Drug: HS-20094 5mg; Administrated by subcutaneous injection; Other Names: HS-20094 injection 5mg
Experimental: HS-20094 10mg; Drug: HS-20094 Administrated by subcutaneous injection Drug: Placebo Administrated by subcutaneous injection Drug: Semaglutide Administrated by subcutaneous injection	Drug: HS-20094 10mg; Administrated by subcutaneous injection; Other Names: HS-20094 injection 10mg
Experimental: HS-20094 15mg; Drug: HS-20094 Administrated by subcutaneous injection Drug: Placebo Administrated by subcutaneous injection Drug: Semaglutide Administrated by subcutaneous injection	Drug: HS-20094 15mg; Administrated by subcutaneous injection; Other Names: HS-20094 injection 15mg
Experimental: HS-20094 20mg; Drug: HS-20094 Administrated by subcutaneous injection Drug: Placebo Administrated by subcutaneous injection Drug: Semaglutide Administrated by subcutaneous injection	Drug: HS-20094 20mg; Administrated by subcutaneous injection; Other Names: HS-20094 injection 20mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse event (AE), serious adverse event (SAE), AE leading to study discontinuation, AE severity and relation with study drug	A summary of AEs and SAEs, AE leading to study discontinuation, AE severity and relation with study drug will be reported in the reported adverse events module	From Baseline to Day 57.
The number of participants with changes of laboratory tests blood routine, urine routine, blood biochemistry, coagulation function		From Baseline to Day 57
The changes ECG examination assessed by PR, R-R, QRS and QTcF	12-lead electrocardiogram (ECG) parameters	From Baseline to Day 57
The changes in Blood pressure	Vital signs	From Baseline to Day 57
Pulse rate	Vital signs	From Baseline to Day 57
Respiratory rate	Vital signs	From Baseline to Day 57
Temperature	Vital signs	From Baseline to Day 57

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Cmax of HS-20094	PK: Cmax of HS-20094	Baseline to Day 57
Pharmacokinetics (PK): Tmax of HS-20094	PK: Tmax of HS-20094	Baseline to Day 57
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of HS-20094	PK: AUC of HS-20094	Baseline to Day 57
Pharmacodynamics (PD): HbA1c	PD: change of HbA1c	Baseline to Day 29

Collaborators and Investigators

• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2023
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: May 25, 2023
• First Submitted That Met QC Criteria: November 3, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: HS-20094-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No