A Study of HS-20094 in T2DM Participants

Type 2 Diabetes Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06118008
• Other study ID #: HS-20094-201
• Status: Recruiting
• Phase: Phase 2
• Start date: May 30, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: May 2023
• Source: Jiangsu Hansoh Pharmaceutical Co., Ltd.
• Contact: Yimin Cui, Doctor
• Phone: 66110802
• Email: cuiymzy[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• HS-20094 5mg
Administrated by subcutaneous injection
• HS-20094 10mg
Administrated by subcutaneous injection
• HS-20094 15mg
Administrated by subcutaneous injection
• HS-20094 20mg
Administrated by subcutaneous injection

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Hansoh Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	The number of participants with changes of laboratory tests blood routine, urine routine, blood biochemistry, coagulation function		From Baseline to Day 57
Primary	The changes ECG examination assessed by PR, R-R, QRS and QTcF	12-lead electrocardiogram (ECG) parameters	From Baseline to Day 57
Primary	The changes in Blood pressure	Vital signs	From Baseline to Day 57
Primary	Pulse rate	Vital signs	From Baseline to Day 57
Primary	Respiratory rate	Vital signs	From Baseline to Day 57
Primary	Temperature	Vital signs	From Baseline to Day 57
Secondary	Pharmacokinetics (PK): Cmax of HS-20094	PK: Cmax of HS-20094	Baseline to Day 57
Secondary	Pharmacokinetics (PK): Tmax of HS-20094	PK: Tmax of HS-20094	Baseline to Day 57
Secondary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of HS-20094	PK: AUC of HS-20094	Baseline to Day 57
Secondary	Pharmacodynamics (PD): HbA1c	PD: change of HbA1c	Baseline to Day 29