Type 2 DiabetesPhase 1NCT07032688
A Clinical Study to Evaluate the Pharmacokinetic and Pharmacodynamics Properties of of SHR-3167 in Subjects With Type 2 Diabetes
A Phase 1 study testing SHR-3167 Injection and Insulin Degludec Injection in people with Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The objective of this study is to evaluate the pharmacokinetics and pharmacodynamics of SHR-3167 at steady state in subjects with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- SHR-3167 Injection and Insulin Degludec Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 11 Aug 2025to Apr 2027
- Phase
- Phase 1
- 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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Informed consent obtained before any trial-related activities.
- Age 18~59 years at screening (including cut-off values at both ends).
- Confirmed diagnosis of type 2 diabetes mellitus ≥ 6 months before screening.
- Female subjects of childbearing potential and their partners are male subjects of childbearing potential, who have no fertility plan and agree to take high-efficiency contraceptive measures within 3 months after signing the informed consent form and have no plans to donate eggs/sperm; Female subjects of childbearing potential have a negative pregnancy test during the screening period and are not lactating.
Who cannot join
- Poor blood pressure control at screening.
- Known or suspected allergy to investigational drug products or related products; or a history of multiple and/or severe allergies to drugs or foods.
- Serious cardiovascular and cerebrovascular diseases within 6 months prior to screening.
- Positive test for hepatitis B surface antigen (HBsAg), HIV antibody, treponema pallidum specific antibody, or hepatitis C virus antibody; or the investigator judges that the subject is in the incubation or active phase of the above infection.
- Malignancy or history of malignancy within 5 years prior to screening.
- Participation in any clinical trial of an approved or unapproved investigational drug/medical device within 90 days prior to screening.
- Any other condition judged by the investigator to be likely to affect the subject's safety or interfere with the evaluation of trial results.
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, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 200433
Yerong Yu, +86-028-85422982, yerongyu@scu.edu.cn
Yerong Yu
About this study
Official title: A Clinical Study to Evaluate the Pharmacokinetic and Pharmacodynamics Properties of of SHR-3167 Injection at Steady State in Subjects With Type 2 Diabetes
The objective of this study is to evaluate the pharmacokinetics and pharmacodynamics of SHR-3167 at steady state in subjects with type 2 diabetes.
- Conditions
- Type 2 Diabetes
- Being tested
- SHR-3167 Injection, Insulin Degludec 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.
SHR-3167 InjectionDrug
SHR-3167 injection.
Insulin Degludec InjectionDrug
Insulin Degludec injection.
| Study group | Role | What they receive |
|---|---|---|
| SHR-3167 Group | Experimental | Not described Receives: Drug: SHR-3167 Injection; Drug: Insulin Degludec Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the SHR-3167 concentration-time curve (AUC SHR-3167, tau, ss).
Measured: From 0 to 168 hours after SHR-3167 administration.
Secondary outcomes (3)
Maximum observed SHR-3167 concentration (Cmax, ss).
Measured: From 0 to 168 hours after SHR-3167 administration.
Adverse events (AEs).
Measured: 21 weeks to 43 weeks.
Hypoglycemic events.
Measured: 21 weeks to 43 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start11 Aug 2025
- Primary completionMar 2027 (estimated)
- Study completionApr 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 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
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
- NCT07032688
- Sponsor's protocol ID
- SHR-3167-103
- Status last verified
- Apr 2026
- First submitted
- 16 Jun 2025
- Last updated
- 17 Apr 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 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Pharmacokinetic and Pharmacodynamics Properties of of SHR-3167 Injection at Steady State in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07032688
- Acronym / sponsor ID
- SHR-3167-103
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 24 Jun 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.
The objective of this study is to evaluate the pharmacokinetics and pharmacodynamics of SHR-3167 at steady state in subjects with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-3167 Group | Experimental | Drug: SHR-3167 Injection, Drug: Insulin Degludec Injection |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Informed consent obtained before any trial-related activities.
- Age 18~59 years at screening (including cut-off values at both ends).
- Confirmed diagnosis of type 2 diabetes mellitus ≥ 6 months before screening.
- Female subjects of childbearing potential and their partners are male subjects of childbearing potential, who have no fertility plan and agree to take high-efficiency contraceptive measures within 3 months after signing the informed consent form and have no plans to donate eggs/sperm; Female subjects of childbearing potential have a negative pregnancy test during the screening period and are not lactating.
Key exclusion criteria (7 listed)
- Poor blood pressure control at screening.
- Known or suspected allergy to investigational drug products or related products; or a history of multiple and/or severe allergies to drugs or foods.
- Serious cardiovascular and cerebrovascular diseases within 6 months prior to screening.
- Positive test for hepatitis B surface antigen (HBsAg), HIV antibody, treponema pallidum specific antibody, or hepatitis C virus antibody; or the investigator judges that the subject is in the incubation or active phase of the above infection.
- Malignancy or history of malignancy within 5 years prior to 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 |
|---|---|---|
| SHR-3167 InjectionSHR-3167 injection. | Drug | SHR-3167 Group |
| Insulin Degludec InjectionInsulin Degludec injection. | Drug | SHR-3167 Group |
Primary outcome
Area under the SHR-3167 concentration-time curve (AUC SHR-3167, tau, ss).
Time frame: From 0 to 168 hours after SHR-3167 administration.
3 secondary outcomes
Maximum observed SHR-3167 concentration (Cmax, ss).
Time frame: From 0 to 168 hours after SHR-3167 administration.
Adverse events (AEs).
Time frame: 21 weeks to 43 weeks.
Hypoglycemic events.
Time frame: 21 weeks to 43 weeks.
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 17 Apr 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR-3167 Injection and Insulin Degludec Injection in people with Type 2 Diabetes, run by Jiangsu HengRui Medicine 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 7 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: looking for participants now, as of the sponsor's last update on 17 Apr 2026. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Han Jianting (+86-0518-82342973, jianting.han.jh27@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the SHR-3167 concentration-time curve (AUC SHR-3167, tau, ss). (time frame: From 0 to 168 hours after SHR-3167 administration.). 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 17 Apr 2026.