A Study of HS-20094 in Patients With T2DM

July 30, 2025 updated by: Jiangsu Hansoh Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
275

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China
        • Tianjin Medical University General Hospital (Zhu Xianyi Memorial Hospital)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female patients 18 to 75 years of age, inclusive
  2. Patients were diagnosed with T2DM for at least 3 months before screening.
  3. 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
  4. Body mass index (BMI）≥ 22 kg/m2.

Exclusion Criteria:

  1. Type 1 diabetes, gestational diabetes, monogenic diabetes, secondary diabetes, or undetermined diabetes as assessed by the investigator
  2. Acute or chronic pancreatitis at any time before screening, or serum lipase/amylase above the upper limit of normal at screening
  3. 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
  4. Occurrence of diabetic ketoacidosis, hyperosmolar coma, or lactic acidosis two or more times within 6 months prior to screening
  5. 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)
  6. Significant weight change (weight gain or loss ≥5%) within 3 months prior to screening (as reported by the participant)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Palcebo
Administrated by subcutaneous injection once a week
Experimental: HS-20094 5mg
Drug: HS-20094
Administrated by subcutaneous injection once a week
Experimental: HS-20094 10mg
Drug: HS-20094
Administrated by subcutaneous injection once a week
Experimental: HS-20094 15mg
Drug: HS-20094
Administrated by subcutaneous injection once a week
Active Comparator: Dulaglutide 1.5mg
Drug: Dulaglutide
Administrated by subcutaneous injection once a week

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The change of HbA1c in the patients
Time Frame: From baseline to week 32
From baseline to week 32

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The percentage of patients reaching the HbA1c target of ≤ 6.5%
Time Frame: From baseline to week 32
From baseline to week 32
The percentage of patients reaching the HbA1c target of<7.0%
Time Frame: From baseline to week 32
From baseline to week 32
The change in fasting blood glucose
Time Frame: From baseline to week 32
From baseline to week 32
The change in C peptide
Time Frame: From baseline to week 32
From baseline to week 32
The change of fasting insulin in the patients
Time Frame: From baseline to week 32
From baseline to week 32
The change in body weight
Time Frame: From baseline to week 32
From baseline to week 32
The percentage of patients with 5% or greater body weight loss
Time Frame: From baseline to week 32
From baseline to week 32

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu Hansoh Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 6, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 7, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 9, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HS-20094-203

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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