Diabetes Mellitus, Type 2Phase 2NCT07472725
A Study Comparing Safety and Efficacy of SHR-3167 Fixed-Dose Titration and Individualized-Dose Titration in Adults With Type 2 Diabetes Inadequately Controlled With Oral Antihyperglycemic Agents
A Phase 2 study testing SHR-3167 Injection in people with Diabetes Mellitus, Type 2, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.
Trial summary
The purpose of this study is to evaluate the safety and glycemic control of SHR-3167 fixed-dose titration and individualized-dose titration in adults with Type 2 Diabetes inadequately controlled with oral antihyperglycemic agents. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- SHR-3167 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 2 sitesChina
- Study dates
- 11 Apr 2026to Feb 2027
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, 18-65 years old at the time of signing informed consent.
- Diagnosed with type 2 diabetes mellitus (T2DM) for at least 6 months prior to day of screening.
- During the screening process, at least one of the oral antihyperglycemic agents must be used (no more than 3 types), and the treatment must be stable for at least 2 months.
- Female participants of childbearing potential and their partners are male participants of childbearing potential, who have no fertility plan and agree to take high-efficiency contraceptive measures within 4 months after signing the informed consent form and have no plans to donate eggs/sperm; Female participants of childbearing potential have a negative pregnancy test during the screening period and are not lactating.
Who cannot join
- Uncontrollable hypertension: systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening.
- Diagnosed or suspected with type 1 diabetes mellitus, latent autoimmune diabetes mellitus in adult (LADA), other special types of diabetes or secondary diabetes.
- Known or suspected allergy or intolerance to the test drug or excipient.
- There was a history of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the previous 6 months.
- There is acute or chronic hepatitis, liver cirrhosis, or a history of other serious liver diseases.
- Malignancy within 5 years prior to screening or high risk of recurrence.
- Those who have a history of severe cardiovascular and cerebrovascular diseases within 6 months before screening.
- Participated in clinical trials of any drug or medical device within 3 months prior to screening.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210003
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518000
About this study
Official title: A Randomized, Open-Label, Treat-to-Target, Parallel-Controlled Phase II Clinical Study to Evaluate the Safety and Efficacy of Fixed-Dose Titration and Individualized-Dose Titration of SHR-3167 in Adults With Type 2 Diabetes Inadequately Controlled With Oral Antihyperglycemic Agents
The purpose of this study is to evaluate the safety and glycemic control of SHR-3167 fixed-dose titration and individualized-dose titration in adults with Type 2 Diabetes inadequately controlled with oral antihyperglycemic agents.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- SHR-3167 Injection, SHR-3167 Injection Placebo
- 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.
SHR-3167 InjectionDrug
SHR-3167 injection.
SHR-3167 Injection PlaceboDrug
SHR-3167 injection placebo.
| Study group | Role | What they receive |
|---|---|---|
| SHR-3167 fixed-dose titration group | Experimental | Not described Receives: Drug: SHR-3167 Injection; Drug: SHR-3167 Injection Placebo |
| SHR-3167 individualized-dose titration group | Experimental | Not described Receives: Drug: SHR-3167 Injection; Drug: SHR-3167 Injection Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of participants who experienced at least one hypoglycemic event.
Measured: From the baseline to 20-weeks treatment.
Secondary outcomes (4)
The event rate of hypoglycemic events.
Measured: From the baseline to 20-weeks treatment.
Change in glycosylated hemoglobin (HbA1c) from baseline.
Measured: From the baseline to 20-weeks treatment.
Change in fasting plasma glucose (FPG) from baseline.
Measured: From the baseline to 20-weeks treatment.
The relative change in HbA1c after 20-weeks treatment compared to the baseline level.
Measured: From the baseline to 20-weeks treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start11 Apr 2026
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine 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
- Model description
- The study is a Phase II clinical trial to evaluate the safety and efficacy of SHR-3167 fixed-dose titration and individualized-dose titration in adults with Type 2 Diabetes inadequately controlled with oral antihyperglycemic agents.
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472725
- Sponsor's protocol ID
- SHR-3167-203
- Status last verified
- Jun 2026
- First submitted
- 11 Mar 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Treat-to-Target, Parallel-Controlled Phase II Clinical Study to Evaluate the Safety and Efficacy of Fixed-Dose Titration and Individualized-Dose Titration of SHR-3167 in Adults With Type 2 Diabetes Inadequately Controlled With Oral Antihyperglycemic Agents
- ClinicalTrials.gov ID
- NCT07472725
- Acronym / sponsor ID
- SHR-3167-203
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Apr 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 16 Mar 2026 (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.
The purpose of this study is to evaluate the safety and glycemic control of SHR-3167 fixed-dose titration and individualized-dose titration in adults with Type 2 Diabetes inadequately controlled with oral antihyperglycemic agents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a Phase II clinical trial to evaluate the safety and efficacy of SHR-3167 fixed-dose titration and individualized-dose titration in adults with Type 2 Diabetes inadequately controlled with oral antihyperglycemic agents.
| Arm | Type | Receives |
|---|---|---|
| SHR-3167 fixed-dose titration group | Experimental | Drug: SHR-3167 Injection, Drug: SHR-3167 Injection Placebo |
| SHR-3167 individualized-dose titration group | Experimental | Drug: SHR-3167 Injection, Drug: SHR-3167 Injection Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females, 18-65 years old at the time of signing informed consent.
- Diagnosed with type 2 diabetes mellitus (T2DM) for at least 6 months prior to day of screening.
- During the screening process, at least one of the oral antihyperglycemic agents must be used (no more than 3 types), and the treatment must be stable for at least 2 months.
- Female participants of childbearing potential and their partners are male participants of childbearing potential, who have no fertility plan and agree to take high-efficiency contraceptive measures within 4 months after signing the informed consent form and have no plans to donate eggs/sperm; Female participants of childbearing potential have a negative pregnancy test during the screening period and are not lactating.
Key exclusion criteria (8 listed)
- Uncontrollable hypertension: systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening.
- Diagnosed or suspected with type 1 diabetes mellitus, latent autoimmune diabetes mellitus in adult (LADA), other special types of diabetes or secondary diabetes.
- Known or suspected allergy or intolerance to the test drug or excipient.
- There was a history of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the previous 6 months.
- There is acute or chronic hepatitis, liver cirrhosis, or a history of other serious liver diseases.
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 |
|---|---|---|
| SHR-3167 InjectionSHR-3167 injection. | Drug | SHR-3167 fixed-dose titration group, SHR-3167 individualized-dose titration group |
| SHR-3167 Injection PlaceboSHR-3167 injection placebo. | Drug | SHR-3167 fixed-dose titration group, SHR-3167 individualized-dose titration group |
Primary outcome
The percentage of participants who experienced at least one hypoglycemic event.
Time frame: From the baseline to 20-weeks treatment.
4 secondary outcomes
The event rate of hypoglycemic events.
Time frame: From the baseline to 20-weeks treatment.
Change in glycosylated hemoglobin (HbA1c) from baseline.
Time frame: From the baseline to 20-weeks treatment.
Change in fasting plasma glucose (FPG) from baseline.
Time frame: From the baseline to 20-weeks treatment.
The relative change in HbA1c after 20-weeks treatment compared to the baseline level.
Time frame: From the baseline to 20-weeks treatment.
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 4 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-3167 Injection in people with Diabetes Mellitus, Type 2, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites 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 8 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: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
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?
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 percentage of participants who experienced at least one hypoglycemic event. (time frame: From the baseline to 20-weeks treatment.). 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 4 Jun 2026.