Type 2 DiabetesPhase 3NCT07156500
A Phase 3 Study of HS-20094 in Patients With T2DM Inadequately Controlled With Diet and Exercise Alone
A Phase 3 study testing HS-20094 Injection in people with Type 2 Diabetes, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of HS-20094 injection in subjects with type 2 diabetes who have inadequate glycemic control with diet and exercise alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- HS-20094 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2025to 30 May 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, Age ≥18 years at the time of signing informed consent.
- Diagnosed with type 2 diabetes mellitus (T2DM) for at least 90 days prior to day of screening.
- Treatment with Diet and Exercise alone at least 90 days prior to day of screening.
- 7.5% ≤ HbA1c ≤10.5% at screening.
Who cannot join
- Uncontrollable hypertension(with or without antihypertensive treatment) : systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening.
- Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
- History of significant hematological disorders (e.g., sickle cell disease, hemolytic anemia, myelodysplastic syndrome, etc.) or other conditions causing hemolysis or instability of red blood cells (e.g., malaria, hypersplenism, etc.).
- Presence of an endocrine disorder or history that may significantly affect bady weight(e.g., Cushing's syndrome, hypothyroidism or hyperthyroidism, except hypothyroidism if thyroid hormone replacement dose has been stable for at least 6 months) ；
- Severe infection, severe trauma, or moderate-to-major surgery within 4 weeks before screening.
- Participated in clinical trials of any drug or medical device within 12 weeks prior to screening, and participation in clinical trials is defined as signing informed consent and using investigational drugs (including placebo) or investigational medical devices; Or is still in the trial drug within 5 half-lives (whichever is Longer).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Hospital
Beijing, Beijing Municipality
Lixin Guo, 13901317569, glx1218@163.com
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo- Parallel Controlled, Phase III Study to Evaluate the Efficacy and Safety of HS-20094 Injection in Subjects With Type 2 Diabetes, Inadequately Controlled With Diet and Exercise Alone
This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of HS-20094 injection in subjects with type 2 diabetes who have inadequate glycemic control with diet and exercise alone. The primary objective of this study is to evaluate the effectiveness of HS-20094 compared to placebo in controlling blood glucose levels after 44 weeks and 52 weeks treatment.
- Conditions
- Type 2 Diabetes
- Being tested
- HS-20094 Injection, HS-20094 Placebo Injection
- 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-20094 InjectionDrug
HS-20094 injected subcutaneously once weekly
HS-20094 Placebo InjectionDrug
HS-20094 Placebo injected subcutaneously once weekly
HS-20094 InjectionDrug
HS-20094 injected subcutaneously once weekly
HS-20094 Placebo InjectionDrug
HS-20094 Placebo injected subcutaneously once weekly
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Drug: HS-20094 Injection |
| Group B | Placebo comparator | Not described Receives: Drug: HS-20094 Placebo Injection |
| Group C | Experimental | Not described Receives: Drug: HS-20094 Injection |
| Group D | Placebo comparator | Not described Receives: Drug: HS-20094 Placebo Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Change from baseline in HbA1c after 44 weeks of treatment
Measured: Week 0 to Week 44
Secondary outcomes (10)
Proportion of subjects with HbA1c<7.0% and ≤6.5%
Proportion of subjects with HbA1c<7.0% and ≤6.5% after 44 weeks of treatment
Measured: Week 0 to Week 44
Change in FPG
Change from baseline in FPG after 44 weeks of treatment
Measured: Week 0 to Week 44
Change in body weight
Change from baseline in Change in body weight after 44 weeks of treatment
Measured: Week 0 to Week 44
Proportion of subjects with weight loss ≥5% and ≥10%
Proportion of subjects with weight loss ≥5% and ≥10% after 44 weeks of treatment
Measured: Week 0 to Week 44
Change in HbA1c
Change from baseline in HbA1c after 52 weeks of treatment
Measured: Week 0 to Week 52
Proportion of subjects with HbA1c<7.0% and ≤6.5%
Proportion of subjects with HbA1c<7.0% and ≤6.5% after 52 weeks of treatment
Measured: Week 0 to Week 52
Change in FPG
Change from baseline in FPG after 52 weeks of treatment
Measured: Week 0 to Week 52
Change in body weight
Change from baseline in Change in body weight after 52 weeks of treatment
Measured: Week 0 to Week 52
Proportion of subjects with weight loss ≥5% and ≥10%
Proportion of subjects with weight loss ≥5% and ≥10% after 52 weeks of treatment
Measured: Week 0 to Week 52
Incidence and severity of adverse events
Severity (mild, moderate and severe) is assessed by investigator
Measured: Week 0 to Week 52+4 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start30 Sep 2025 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion30 May 2027 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 204 participants (estimated)
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
- NCT07156500
- Sponsor's protocol ID
- HS-20094-302
- Status last verified
- Aug 2025
- First submitted
- 28 Aug 2025
- Last updated
- 5 Sep 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 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo- Parallel Controlled, Phase III Study to Evaluate the Efficacy and Safety of HS-20094 Injection in Subjects With Type 2 Diabetes, Inadequately Controlled With Diet and Exercise Alone
- ClinicalTrials.gov ID
- NCT07156500
- Acronym / sponsor ID
- HS-20094-302
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 5 Sep 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 multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of HS-20094 injection in subjects with type 2 diabetes who have inadequate glycemic control with diet and exercise alone. The primary objective of this study is to evaluate the effectiveness of HS-20094 compared to placebo in controlling blood glucose levels after 44 weeks and 52 weeks treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: HS-20094 Injection |
| Group B | Placebo comparator | Drug: HS-20094 Placebo Injection |
| Group C | Experimental | Drug: HS-20094 Injection |
| Group D | Placebo comparator | Drug: HS-20094 Placebo Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females, Age ≥18 years at the time of signing informed consent.
- Diagnosed with type 2 diabetes mellitus (T2DM) for at least 90 days prior to day of screening.
- Treatment with Diet and Exercise alone at least 90 days prior to day of screening.
- 7.5% ≤ HbA1c ≤10.5% at screening.
Key exclusion criteria (6 listed)
- Uncontrollable hypertension(with or without antihypertensive treatment) : systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening.
- Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
- History of significant hematological disorders (e.g., sickle cell disease, hemolytic anemia, myelodysplastic syndrome, etc.) or other conditions causing hemolysis or instability of red blood cells (e.g., malaria, hypersplenism, etc.).
- Presence of an endocrine disorder or history that may significantly affect bady weight(e.g., Cushing's syndrome, hypothyroidism or hyperthyroidism, except hypothyroidism if thyroid hormone replacement dose has been stable for at least 6 months) ；
- Severe infection, severe trauma, or moderate-to-major surgery within 4 weeks before screening.
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-20094 InjectionHS-20094 injected subcutaneously once weekly | Drug | Group A |
| HS-20094 Placebo InjectionHS-20094 Placebo injected subcutaneously once weekly | Drug | Group B |
| HS-20094 InjectionHS-20094 injected subcutaneously once weekly | Drug | Group C |
| HS-20094 Placebo InjectionHS-20094 Placebo injected subcutaneously once weekly | Drug | Group D |
Primary outcome
Change in HbA1c
Time frame: Week 0 to Week 44
Change from baseline in HbA1c after 44 weeks of treatment
10 secondary outcomes
Proportion of subjects with HbA1c<7.0% and ≤6.5%
Time frame: Week 0 to Week 44
Change in FPG
Time frame: Week 0 to Week 44
Change in body weight
Time frame: Week 0 to Week 44
Proportion of subjects with weight loss ≥5% and ≥10%
Time frame: Week 0 to Week 44
Change in HbA1c
Time frame: Week 0 to Week 52
Proportion of subjects with HbA1c<7.0% and ≤6.5%
Time frame: Week 0 to Week 52
Change in FPG
Time frame: Week 0 to Week 52
Change in body weight
Time frame: Week 0 to Week 52
Proportion of subjects with weight loss ≥5% and ≥10%
Time frame: Week 0 to Week 52
Incidence and severity of adverse events
Time frame: Week 0 to Week 52+4 weeks follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HS-20094 Injection 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: opening soon, as of the sponsor's last update on 5 Sep 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (time frame: Week 0 to Week 44). 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 5 Sep 2025.