Peking University First Hospital
Beijing, Beijing Municipality, China
NCT Number: NCT06118008
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.
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Notify Me20 year–65 year
All sexes
Interventional
Phase 2
Beijing, Beijing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administrated by subcutaneous injection
Other names: HS-20094 injection 5mg
Administrated by subcutaneous injection
Other names: HS-20094 injection 10mg
Administrated by subcutaneous injection
Other names: HS-20094 injection 15mg
Administrated by subcutaneous injection
Other names: HS-20094 injection 20mg
Time frame: 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
Time frame: From Baseline to Day 57
Time frame: From Baseline to Day 57
12-lead electrocardiogram (ECG) parameters
Time frame: From Baseline to Day 57
Vital signs
Time frame: From Baseline to Day 57
Vital signs
Time frame: From Baseline to Day 57
Vital signs
Time frame: From Baseline to Day 57
Vital signs
Time frame: Baseline to Day 57
PK: Cmax of HS-20094
Time frame: Baseline to Day 57
PK: Tmax of HS-20094
Time frame: Baseline to Day 57
PK: AUC of HS-20094
Time frame: Baseline to Day 29
PD: change of HbA1c
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Industry
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.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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