A Study of HS-20094 in T2DM Participants
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| 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:
|
| 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:
|
| 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:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- 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
- The changes in Blood pressure [From Baseline to Day 57]
Vital signs
- Pulse rate [From Baseline to Day 57]
Vital signs
- Respiratory rate [From Baseline to Day 57]
Vital signs
- Temperature [From Baseline to Day 57]
Vital signs
Secondary Outcome Measures
- Pharmacokinetics (PK): Cmax of HS-20094 [Baseline to Day 57]
PK: Cmax of HS-20094
- 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
Eligibility Criteria
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.
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Severe infection such as diabetic foot infection, pneumonia, or sepsis within 30 days before screening.
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Uncontrollable hypertension.
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History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening.
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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.
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Pregnant or lactating woman.
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In the investigator's judgment, there were circumstances that affected subject safety or otherwise interfered with the evaluation of results.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking University First Hospital | Beijing | Beijing | China |
Sponsors and Collaborators
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HS-20094-201