A Study of HS-20094 in T2DM Participants

Phase 2

Recruiting

• Conditions: Type 2 Diabetes
• Interventions: Drug: HS-20094 10mg; Drug: HS-20094 5mg; Drug: HS-20094 20mg; Drug: HS-20094 15mg

• Registration Number: NCT06118008
• Lead Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-25
• Study Start: 2023-05-30
• Study First Submitted QC: 2023-11-03
• Last Update Submitted: 2023-11-03
• Study First Posted: 2023-11-07
• Last Update Posted: 2023-11-07
• Primary Completion: 2024-02-01
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HS-20094 10mg	HS-20094 10mg	Drug: HS-20094 Administrated by subcutaneous injection Drug: Placebo Administrated by subcutaneous injection Drug: Semaglutide Administrated by subcutaneous injection
HS-20094 5mg	HS-20094 5mg	Drug: HS-20094 Administrated by subcutaneous injection Drug: Placebo Administrated by subcutaneous injection Drug: Semaglutide Administrated by subcutaneous injection
HS-20094 20mg	HS-20094 20mg	Drug: HS-20094 Administrated by subcutaneous injection Drug: Placebo Administrated by subcutaneous injection Drug: Semaglutide Administrated by subcutaneous injection
HS-20094 15mg	HS-20094 15mg	Drug: HS-20094 Administrated by subcutaneous injection Drug: Placebo Administrated by subcutaneous injection Drug: Semaglutide Administrated by subcutaneous injection

Primary Outcome Measures

Name	Time	Method
Pulse rate	From Baseline to Day 57	Vital signs
The changes in Blood pressure	From Baseline to Day 57	Vital signs
Respiratory rate	From Baseline to Day 57	Vital signs
Incidence of adverse event (AE), serious adverse event (SAE), AE leading to study discontinuation, AE severity and relation with study drug	From Baseline to Day 57.	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
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	From Baseline to Day 57	12-lead electrocardiogram (ECG) parameters
Temperature	From Baseline to Day 57	Vital signs

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China