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Completed

NCT Number: NCT06118008

A Study of HS-20094 in T2DM Participants

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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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HS-20094 5mg

Drug

Administrated by subcutaneous injection

Other names: HS-20094 injection 5mg

HS-20094 10mg

Drug

Administrated by subcutaneous injection

Other names: HS-20094 injection 10mg

HS-20094 15mg

Drug

Administrated by subcutaneous injection

Other names: HS-20094 injection 15mg

HS-20094 20mg

Drug

Administrated by subcutaneous injection

Other names: HS-20094 injection 20mg

Primary outcomes

  1. Incidence of adverse event (AE), serious adverse event (SAE), AE leading to study discontinuation, AE severity and relation with study drug

    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

  2. The number of participants with changes of laboratory tests blood routine, urine routine, blood biochemistry, coagulation function

    Time frame: From Baseline to Day 57

  3. The changes ECG examination assessed by PR, R-R, QRS and QTcF

    Time frame: From Baseline to Day 57

    12-lead electrocardiogram (ECG) parameters

  4. The changes in Blood pressure

    Time frame: From Baseline to Day 57

    Vital signs

  5. Pulse rate

    Time frame: From Baseline to Day 57

    Vital signs

  6. Respiratory rate

    Time frame: From Baseline to Day 57

    Vital signs

  7. Temperature

    Time frame: From Baseline to Day 57

    Vital signs

Secondary outcomes

  1. Pharmacokinetics (PK): Cmax of HS-20094

    Time frame: Baseline to Day 57

    PK: Cmax of HS-20094

  2. Pharmacokinetics (PK): Tmax of HS-20094

    Time frame: Baseline to Day 57

    PK: Tmax of HS-20094

  3. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of HS-20094

    Time frame: Baseline to Day 57

    PK: AUC of HS-20094

  4. Pharmacodynamics (PD): HbA1c

    Time frame: Baseline to Day 29

    PD: change of HbA1c

Sponsors and collaborators

Lead sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 7, 2023
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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