Clinical trial NCT06118008: A Study of HS-20094 in T2DM Participants
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Type 2 Diabetes
Lead sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-11-07
Enrollment: 96
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Incidence of adverse event (AE), serious adverse event (SAE), AE leading to study discontinuation, AE severity and relation with study drug
timeFrame: From Baseline to Day 57.
measure: The number of participants with changes of laboratory tests blood routine, urine routine, blood biochemistry, coagulation function
timeFrame: From Baseline to Day 57
measure: The changes ECG examination assessed by PR, R-R, QRS and QTcF
timeFrame: From Baseline to Day 57
measure: The changes in Blood pressure
timeFrame: From Baseline to Day 57
measure: Pulse rate
timeFrame: From Baseline to Day 57
measure: Respiratory rate
timeFrame: From Baseline to Day 57
measure: Temperature
timeFrame: From Baseline to Day 57
Secondary outcomes:
measure: Pharmacokinetics (PK): Cmax of HS-20094
timeFrame: Baseline to Day 57
measure: Pharmacokinetics (PK): Tmax of HS-20094
timeFrame: Baseline to Day 57
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of HS-20094
timeFrame: Baseline to Day 57
measure: Pharmacodynamics (PD): HbA1c
timeFrame: Baseline to Day 29
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
References: