Type 2 DiabetesPhase 2NCT06901648
A Study of HS-20094 in Patients With T2DM
A Phase 2 study testing HS-20094, Dulaglutide and Palcebo in people with Type 2 Diabetes, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- HS-20094, Dulaglutide and Palcebo
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 275 participants
- Where
- 1 siteChina
- Study dates
- 6 Feb 2024to 9 Apr 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University General Hospital (Zhu Xianyi Memorial Hospital)
Tianjin, Tianjin Municipality
About this study
Official 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
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.
- Conditions
- Type 2 Diabetes
- Being tested
- HS-20094, Dulaglutide, Palcebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-20094Drug
Administrated by subcutaneous injection once a week
DulaglutideDrug
Administrated by subcutaneous injection once a week
PalceboDrug
Administrated by subcutaneous injection once a week
| Study group | Role | What they receive |
|---|---|---|
| HS-20094 5mg | Experimental | Not described Receives: Drug: HS-20094 |
| HS-20094 10mg | Experimental | Not described Receives: Drug: HS-20094 |
| HS-20094 15mg | Experimental | Not described Receives: Drug: HS-20094 |
| Dulaglutide 1.5mg | Active comparator | Not described Receives: Drug: Dulaglutide |
| Placebo | Placebo comparator | Not described Receives: Drug: Palcebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of HbA1c in the patients
Measured: From baseline to week 32
Secondary outcomes (7)
The percentage of patients reaching the HbA1c target of ≤ 6.5%
Measured: From baseline to week 32
The percentage of patients reaching the HbA1c target of<7.0%
Measured: From baseline to week 32
The change in fasting blood glucose
Measured: From baseline to week 32
The change in C peptide
Measured: From baseline to week 32
The change of fasting insulin in the patients
Measured: From baseline to week 32
The change in body weight
Measured: From baseline to week 32
The percentage of patients with 5% or greater body weight loss
Measured: From baseline to week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start6 Feb 2024
- Primary completion7 Mar 2025
- Study completion9 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06901648
- Sponsor's protocol ID
- HS-20094-203
- Status last verified
- Jul 2025
- First submitted
- 25 Feb 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06901648
- Acronym / sponsor ID
- HS-20094-203
- Conditions
- Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 7 Mar 2025 (actual)
- Study completion
- 9 Apr 2025 (actual)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| HS-20094 5mg | Experimental | Drug: HS-20094 |
| HS-20094 10mg | Experimental | Drug: HS-20094 |
| HS-20094 15mg | Experimental | Drug: HS-20094 |
| Dulaglutide 1.5mg | Active comparator | Drug: Dulaglutide |
| Placebo | Placebo comparator | Drug: Palcebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-20094Administrated by subcutaneous injection once a week | Drug | HS-20094 10mg, HS-20094 15mg, HS-20094 5mg |
| DulaglutideAdministrated by subcutaneous injection once a week | Drug | Dulaglutide 1.5mg |
| PalceboAdministrated by subcutaneous injection once a week | Drug | Placebo |
Primary outcome
The change of HbA1c in the patients
Time frame: From baseline to week 32
7 secondary outcomes
The percentage of patients reaching the HbA1c target of ≤ 6.5%
Time frame: From baseline to week 32
The percentage of patients reaching the HbA1c target of<7.0%
Time frame: From baseline to week 32
The change in fasting blood glucose
Time frame: From baseline to week 32
The change in C peptide
Time frame: From baseline to week 32
The change of fasting insulin in the patients
Time frame: From baseline to week 32
The change in body weight
Time frame: From baseline to week 32
The percentage of patients with 5% or greater body weight loss
Time frame: From baseline to week 32
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HS-20094, Dulaglutide and Palcebo in people with Type 2 Diabetes, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of HbA1c in the patients (time frame: From baseline to week 32). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.