Skip to main content
OpenTrials
Completed

NCT Number: NCT06901648

A Study of HS-20094 in Patients With T2DM

This is a 32-week, phase 2, randomized study, HS-20094 and placebo were double-blind, dulaglutide was open-label. Adults with T2D inadequately controlled with diet and exercise alone or with stable metformin, an HbA1c (glycated hemoglobin) ≥53 to ≤91 mmol/mol (≥7.0 % to≤10.5 %) were randomly assigned to receive 5 mg HS-20094, 10 mg HS-20094, 15 mg HS-20094, placebo, or 1.5 mg dulaglutide subcutaneously for 32 weeks. The primary endpoint was change in HbA1C from baseline to 32 weeks, and secondary endpoints included change in fasting glucose, body weight and several additional measures relevant for cardiovascular risks.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tianjin Medical University General Hospital (Zhu Xianyi Memorial Hospital)

Tianjin, Tianjin 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 patients 18 to 75 years of age, inclusive
  • Patients were diagnosed with T2DM for at least 3 months before screening.
  • Have an HbA1c value at screening of ≥7.0% and ≤10.5% and treated with diet and exercise alone or a stable dose of metformin (either immediate release or extended release, ≥1000mg/day and not more than the locally approved dose) for at least 2 months prior to screening
  • Body mass index (BMI)≥ 22 kg/m2.

Exclusion criteria

  • Type 1 diabetes, gestational diabetes, monogenic diabetes, secondary diabetes, or undetermined diabetes as assessed by the investigator
  • 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 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
  • Occurrence of diabetic ketoacidosis, hyperosmolar coma, or lactic acidosis two or more times within 6 months prior to screening
  • Occurrence of any of the following events within 6 months prior to screening: acute myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention (excluding diagnostic angiography), transient ischemic attack, cerebrovascular accident, decompensated congestive heart failure, or Class III or IV heart failure (NYHA classification)
  • Significant weight change (weight gain or loss ≥5%) within 3 months prior to screening (as reported by the participant)

Treatment and study plan

HS-20094

Drug

Administrated by subcutaneous injection once a week

Dulaglutide

Drug

Administrated by subcutaneous injection once a week

Palcebo

Drug

Administrated by subcutaneous injection once a week

Primary outcomes

  1. The change of HbA1c in the patients

    Time frame: From baseline to week 32

Secondary outcomes

  1. The percentage of patients reaching the HbA1c target of ≤ 6.5%

    Time frame: From baseline to week 32

  2. The percentage of patients reaching the HbA1c target of<7.0%

    Time frame: From baseline to week 32

  3. The change in fasting blood glucose

    Time frame: From baseline to week 32

  4. The change in C peptide

    Time frame: From baseline to week 32

  5. The change of fasting insulin in the patients

    Time frame: From baseline to week 32

  6. The change in body weight

    Time frame: From baseline to week 32

  7. The percentage of patients with 5% or greater body weight loss

    Time frame: From baseline to week 32

Sponsors and collaborators

Lead sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

Efficacy and Safety of HS-20094, a Novel Dual GIP and GLP-1 Receptor Agonist, in Patients With Type 2 Diabetes: a Randomized, Placebo-controlled and Active Comparator-controlled Phase 2 Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 30, 2025
Registry last updated
Aug 1, 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.

Published trials that share one or more normalized conditions with this study.