Improved Glycemic Control in Patients With Type 2 DiabetesPhase 1NCT05292495
A Trial of HR17031 Injection With Renal Insufficiency
A Phase 1 study testing HR17031 injection in people with Improved Glycemic Control in Patients With Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This study used a single-dose, open design to compare the pharmacokinetics of subjects with mild, moderate and severe renal insufficiency and end-stage renal disease and subjects with normal renal function. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Improved Glycemic Control in Patients With Type 2 Diabetes
- What is being tested?
- HR17031 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 12 Oct 2022to 10 Apr 2024
- Phase
- Phase 1
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Renal impairment subjects Inclusion Criteria:
- Signed the informed consent before the test, and fully understood the test content, process and possible adverse reactions; And able to complete the research according to the requirements of the test protocol.
- Age 18-70 (including threshold), male and female.
- Body mass index (BMI): 18~30 kg/m2 (including critical value).
- Creatinine clearance (CLcr, calculated by the Cockcroft-Gault formula) must meet the following criteria: Subjects with mild renal insufficiency: 60-89 mL/min (including cutoffs); Subjects with moderate renal impairment: 30-59 mL/min (including cutoffs); Subjects with severe renal impairment: 15-29 mL/min (including cutoffs); Subjects with end-stage renal insufficiency: <15 mL/min.
- The renal function status is stable, and the CLcr results of the two tests before administration (the two tests need to be separated by at least 3 days, but within 14 days) should be within ±25%. If the second result is not within ±25%, a third test can be performed (at least 3 days from the second test, but within 14 days). The third test result needs to be within ±25% of the second test result. Calculation formula: (third result - second result)/second result. The test results within 24 hours before administration will be used for the final trial grouping and subsequent PK analysis.
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- Females of childbearing age must take reliable contraceptive measures and be willing to use appropriate methods of contraception during the trial and within 10 weeks after the last administration of the test drug; male subjects are willing to have no reproductive plans during the trial and within 10 weeks after the last administration of the test drug and Voluntary use of effective contraception, or surgical sterilization.
- For patients with other underlying diseases requiring drug treatment, the dose needs to be kept stable during this study.
- Healthy subjects Inclusion Criteria:
- Signed the informed consent before the test, and fully understood the test content, process and possible adverse reactions; And able to complete the research according to the requirements of the test protocol.
- Able to complete the research in accordance with the requirements of the experimental protocol.
- Age 18-70 (including threshold), male and female.
- Body mass index (BMI): 18~30 kg/m2 (including critical value).
- Creatinine clearance rate (CLcr, calculated by Cockcroft-Gault formula) ≥ 90mL/min.
- The renal function status is stable, and the CLcr results of the two tests before administration (the two tests need to be separated by at least 3 days, but within 14 days) should be within ±25%. Calculation formula: (second result - first result)/first result. The test results within 24 hours before administration will be used for the final trial grouping and subsequent PK analysis.
- Females of childbearing age must take reliable contraceptive measures and be willing to use appropriate methods of contraception during the trial and within 10 weeks after the last administration of the test drug; male subjects are willing to have no reproductive plans during the trial and within 10 weeks after the last administration of the test drug and Voluntary use of effective contraception, or surgical sterilization.
Who cannot join
- Exclusion Criteria for subjects with mild, moderate and severe renal impairment:
- Have done kidney transplantation.
- Renal dialysis is required during the study.
- Those with allergic constitution, including those with a history of severe drug allergy or drug allergy, or known or suspected to be allergic to any component in the study drug.
- Urinary incontinence or anuria (eg <100ml/d).
- Those who have a history of drug and/or alcohol abuse, who are positive for alcohol and drug screening, or who have a history of drug abuse in the past five years or who have used drugs in the 3 months before the test; and who cannot smoke or abstain from alcohol during the test.
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- Pregnant or lactating women, or those with a positive blood pregnancy result.
- Those who donated blood or participated in any clinical trial drugs within 3 months before screening.
- Those who have taken other prescription drugs, over-the-counter drugs, Chinese herbal medicines or food supplements other than those used to treat renal insufficiency and other concomitant diseases within 14 days before administration.
- Combined with other viral infections (anti-HCV, anti-HIV positive, HBsAg positive or combined with positive syphilis serology).
- Major surgery or surgical incision was not fully healed within 6 months before screening.
- History or clinical symptoms of deep vein thrombosis or other thromboembolic events suggest thrombophilia.
- Active heart disease within 6 months before the first administration of the study drug, including: severe/unstable angina pectoris, myocardial infarction, symptomatic congestive heart failure and ventricular arrhythmia requiring drug treatment.
- Have a history of epilepsy, or a disease that can induce epileptic seizures within 12 months before the first administration of the study drug (including a history of transient ischemic attack, cerebral apoplexy (except for cerebral ischemic lesions found by simple imaging examination), Brain trauma with disturbance of consciousness requires hospitalization).
- Malignant tumors, or a history of malignant tumors within 5 years before screening (except for skin non-melanoma that has been treated and has no signs of recurrence, and excised cervical intraepithelial neoplasia).
- In addition to renal insufficiency and other concomitant diseases, the researcher makes judgments based on medical history inquiry, comprehensive physical examination, routine laboratory tests (blood routine, blood biochemistry, urine routine, etc.), X-chest X-ray, abdominal B-ultrasound, etc. Abnormal clinical significance.
- 12-ECG abnormality with clinical significance and uncontrollable by drugs (if uncontrolled tachycardia/bradycardia, II-III degree atrioventricular block or prolongation of QTcF interval (male ≥ 470 ms, female ≥ 470 ms) 480 ms) (corrected by Fridericia's formula) or other clinically significant abnormalities judged by the clinician).
- 48 hours before taking the study drug until the end of the study, the subject refuses to stop any beverages containing methylxanthine, such as caffeine (coffee, tea, cola, chocolate, etc.) or alcoholic beverages or any fruit juice.
- Vigorous exercise within 48 hours before administration, or other factors affecting drug distribution, metabolism, excretion, etc..
- Those with a history of fainting, fainting of blood, difficult to collect blood or unable to tolerate venipuncture for blood collection.
- Those who have used insulin or glucagon-like polypeptide-1 receptor agonist (GLP-1) hypoglycemic drugs within 3 months before screening.
- Those who have been vaccinated or exposed to other live vaccines or live attenuated vaccines within 3 months before screening; or those who plan to receive live vaccines or live attenuated vaccines during the study period.
- According to the judgment of the researcher, there are concomitant diseases (such as poorly controlled hypertension, severe diabetes, thyroid disease and mental illness, etc.) or any other conditions that seriously endanger the safety of patients, or affect the completion of the study.
- Exclusion Criteria for ESRD:
- Have done kidney transplantation.
- Those with allergic constitution, including those with a history of severe drug allergy or drug allergy, or known or suspected to be allergic to any component of the study drug.
- Urinary incontinence or anuria (eg <100ml/d).
- Those who have a history of drug and/or alcohol abuse, who are positive for alcohol and drug screening, or who have a history of drug abuse in the past five years or who have used drugs in the 3 months before the test; and who cannot smoke and abstain during the test.
- Pregnant or lactating women, or those with a positive blood pregnancy result.
- Those who donated blood or participated in any clinical trial drug within 3 months before screening.
- Those who have taken other prescription drugs, over-the-counter drugs, Chinese herbal medicines or food supplements other than those used to treat renal insufficiency and other concomitant diseases within 14 days before administration.
- Combined with other viral infections (anti-HCV, anti-HIV positive, HBsAg positive or combined with positive syphilis serology).
- Received major surgery within 6 months before screening or the surgical incision was not completely healed.
- History or clinical symptoms of deep vein thrombosis or other thromboembolic events suggest thrombophilia.
- Active heart disease within 6 months before the first administration of the study drug, including: severe/unstable angina, myocardial infarction, symptomatic congestive heart failure and ventricular arrhythmia requiring drug treatment.
- Have a history of epilepsy, or a disease that can induce epileptic seizures within 12 months before the first administration of the study drug (including a history of transient ischemic attack, cerebral apoplexy (except for cerebral ischemic lesions found by simple imaging examination), Brain trauma with disturbance of consciousness requires hospitalization).
- Suffering from malignant tumor, or a history of malignant tumor within 5 years before screening (except for skin non-melanoma that has been treated and has no signs of recurrence, and excised cervical intraepithelial neoplasia).
- In addition to renal insufficiency and other concomitant diseases, the researcher makes judgments based on medical history inquiry, comprehensive physical examination, routine laboratory tests (blood routine, blood biochemistry, urine routine, etc.), X-chest X-ray, abdominal B-ultrasound, etc. Abnormal clinical significance.
- 12-ECG abnormality is clinically significant and uncontrollable by drugs (if uncontrolled tachycardia/bradycardia, II-III degree atrioventricular block or prolongation of QTcF interval (men ≥ 470 ms, women ≥ 470 ms) 480 ms) (corrected by Fridericia's formula) or other clinically significant abnormalities judged by the clinician).
- 48 hours before taking the study drug until the end of the study, the subject refuses to stop any beverages containing methylxanthine, such as caffeine (coffee, tea, cola, chocolate, etc.) or alcoholic beverages or any fruit juice.
- Vigorous exercise within 48 hours before administration, or other factors affecting drug distribution, metabolism, excretion, etc..
- Those with a history of fainting of needles, fainting of blood, difficulty in blood collection or intolerance of venipuncture for blood collection.
- Those who have used insulin or glucagon-like polypeptide-1 receptor agonist (GLP-1) hypoglycemic drugs within 3 months before screening.
- Those who have been vaccinated or exposed to other live vaccines or live attenuated vaccines within 3 months before screening; or those who plan to receive live vaccines or live attenuated vaccines during the study period.
- According to the judgment of the researcher, there are concomitant diseases (such as poorly controlled hypertension, severe diabetes, thyroid disease and mental illness, etc.) or any other conditions that seriously endanger the safety of patients, or affect the completion of the study.
- Exclusion Criteria for Healthy subject:
- Chronic kidney disease damage and kidney transplantation.
- Those with allergic constitution, including those with a history of severe drug allergy or drug allergy, or known or suspected to be allergic to any component of the study drug.
- Those who have a history of drug and/or alcohol abuse, who are positive for alcohol and drug screening, or who have a history of drug abuse in the past five years or who have used drugs in the 3 months before the test; and who cannot smoke or abstain from alcohol during the test.
- Pregnant or breastfeeding women, or those with a positive blood pregnancy result.
- Those who donated blood or took any clinical trial drugs within 3 months before screening.
- Those who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or food supplements within 14 days before administration.
- Combined with other viral infections (anti-HCV, anti-HIV positive, HBsAg positive or combined with positive syphilis serology).
- Those who have undergone any surgery within 6 months before screening.
- History or clinical symptoms of deep vein thrombosis or other thromboembolic events suggest thrombophilia.
- Active heart disease within 6 months before the first administration of the study drug, including: severe/unstable angina, myocardial infarction, symptomatic congestive heart failure and ventricular arrhythmia requiring drug treatment.
- Have a history of epilepsy, or a disease that can induce epileptic seizures within 12 months before the first administration of the study drug (including history of transient ischemic attack, cerebral apoplexy (except for cerebral ischemic foci found by simple imaging examination), Brain trauma with disturbance of consciousness requires hospitalization).
- Suffering from malignant tumor, or a history of malignant tumor within 5 years before screening (except for skin non-melanoma that has been treated and has no signs of recurrence, and excised cervical intraepithelial neoplasia).
- Comprehensive physical examination (vital signs, physical examination), routine laboratory examinations (blood routine, blood biochemistry, urine routine, thrombin function, etc.), X-chest X-ray, abdominal B-ultrasound and other abnormal examinations with clinical significance.
- 12-ECG abnormalities with clinical significance and uncontrollable by drugs (if uncontrolled tachycardia/bradycardia, II-III degree atrioventricular block or prolongation of QTcF interval (≥470 ms in males, ≥470 ms in females) 480 ms) (corrected by Fridericia's formula) or other clinically significant abnormalities judged by the clinician).
- 48 hours before taking the study drug until the end of the study, the subject refuses to stop any beverages containing methylxanthine, such as caffeine (coffee, tea, cola, chocolate, etc.) or alcoholic beverages or any fruit juice.
- Vigorous exercise within 48 hours before administration, or other factors affecting drug distribution, metabolism, excretion, etc..
- Those with a history of needle fainting, haemorrhage, difficulty in blood collection or intolerance of venipuncture for blood collection.
- Those who have used insulin or glucagon-like polypeptide-1 receptor agonist (GLP-1) hypoglycemic drugs within 3 months before screening.
- Those who have been vaccinated or exposed to other live vaccines or live attenuated vaccines within 3 months before screening; or those who plan to receive live vaccines or live attenuated vaccines during the study period.
- According to the judgment of the investigator, there are concomitant diseases (such as poorly controlled hypertension, severe diabetes, thyroid disease and mental illness, etc.) or any other conditions that seriously endanger the safety of patients, or affect the completion of the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100009
About this study
Official title: A Single-dose, Open Design Study to Evaluate The Pharmacokinetics of HR17031 Injection With Renal Insufficiency
This study used a single-dose, open design to compare the pharmacokinetics of subjects with mild, moderate and severe renal insufficiency and end-stage renal disease and subjects with normal renal function.
- Being tested
- HR17031 injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR17031 injectionDrug
HR17031 injection; administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Cohort one: mild renal insufficiency | Experimental | Not described Receives: Drug: HR17031 injection |
| Cohort two: moderate renal insufficiency | Experimental | Not described Receives: Drug: HR17031 injection |
| Cohort three: severe renal insufficiency | Experimental | Not described Receives: Drug: HR17031 injection |
| Cohort four: end-stage renal disease | Experimental | Not described Receives: Drug: HR17031 injection |
| Cohort five: normal renal function | Experimental | Not described Receives: Drug: HR17031 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics parameters of INS068 and SHR20004: Cmax
Measured: Based on pre-dose, 2-96 hours post-dose sampling times
Pharmacokinetics parameters of INS068 and SHR20004: AUC0-t
Measured: Based on pre-dose, 2-96 hours post-dose sampling times
Pharmacokinetics parameters of INS068 and SHR20004: AUC0-inf
Measured: Based on pre-dose, 2-96 hours post-dose sampling times
Secondary outcomes (13)
Pharmacokinetics parameters of INS068 and SHR20004: Tmax
Measured: Based on pre-dose, 2-96 hours post-dose sampling times
Pharmacokinetics parameters of INS068 and SHR20004: T1/2
Measured: Based on pre-dose, 2-96 hours post-dose sampling times
Pharmacokinetics parameters of INS068 and SHR20004: CL/F
Measured: Based on pre-dose, 2-96 hours post-dose sampling times
Pharmacokinetics parameters of INS068 and SHR20004: Vz/F
Measured: Based on pre-dose, 2-96 hours post-dose sampling times
Pharmacokinetics parameters of INS068 and SHR20004: Ae
Measured: Based on pre-dose, 2-96 hours post-dose sampling times
Pharmacokinetics parameters of INS068 and SHR20004: fe
Measured: Based on pre-dose, 2-96 hours post-dose sampling times
Pharmacokinetics parameters of INS068 and SHR20004: CLr
Measured: Based on pre-dose, 2-96 hours post-dose sampling times
Average concentrations of INS068 and SHR20004 in dialysate of ESRD
Measured: 0- 4 hours post-dose sampling times
Cumulative collection amount of INS068 and SHR20004 in dialysate of ESRD
Measured: 0- 4 hours post-dose sampling times
Dialysis clearance of INS068 and SHR20004 in dialysate of ESRD
Measured: 0- 4 hours post-dose sampling times
Binding rate of plasma protein of INS068 in serum and SHR20004 in plasma(fu)
Measured: Based on pre-dose, 2-96 hours post-dose sampling times
The incidence and severity of adverse events/serious adverse events
Measured: Based on pre-dose, 2-96 hours post-dose sampling times
ADA：anti-drug antibody
Measured: Based on pre-dose、Day 5、Day14、Day 24 or early termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start12 Oct 2022
- Primary completion10 Apr 2024
- Study completion10 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Improved Glycemic Control in Patients With 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Compare the pharmacokinetics of HR17031 injection in subjects with mild, moderate, severe renal insufficiency and end-stage renal disease and subjects with normal renal function.
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT05292495
- Sponsor's protocol ID
- HR17031-105
- Status last verified
- May 2026
- First submitted
- 15 Mar 2022
- Last updated
- 22 May 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-dose, Open Design Study to Evaluate The Pharmacokinetics of HR17031 Injection With Renal Insufficiency
- ClinicalTrials.gov ID
- NCT05292495
- Acronym / sponsor ID
- HR17031-105
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 10 Apr 2024 (actual)
- Study completion
- 10 Apr 2024 (actual)
- First posted
- 23 Mar 2022 (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 study used a single-dose, open design to compare the pharmacokinetics of subjects with mild, moderate and severe renal insufficiency and end-stage renal disease and subjects with normal renal function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Compare the pharmacokinetics of HR17031 injection in subjects with mild, moderate, severe renal insufficiency and end-stage renal disease and subjects with normal renal function.
| Arm | Type | Receives |
|---|---|---|
| Cohort one: mild renal insufficiency | Experimental | Drug: HR17031 injection |
| Cohort two: moderate renal insufficiency | Experimental | Drug: HR17031 injection |
| Cohort three: severe renal insufficiency | Experimental | Drug: HR17031 injection |
| Cohort four: end-stage renal disease | Experimental | Drug: HR17031 injection |
| Cohort five: normal renal function | Experimental | Drug: HR17031 injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Renal impairment subjects Inclusion Criteria:
- Signed the informed consent before the test, and fully understood the test content, process and possible adverse reactions; And able to complete the research according to the requirements of the test protocol.
- Age 18-70 (including threshold), male and female.
- Body mass index (BMI): 18~30 kg/m2 (including critical value).
- Creatinine clearance (CLcr, calculated by the Cockcroft-Gault formula) must meet the following criteria: Subjects with mild renal insufficiency: 60-89 mL/min (including cutoffs); Subjects with moderate renal impairment: 30-59 mL/min (including cutoffs); Subjects with severe renal impairment: 15-29 mL/min (including cutoffs); Subjects with end-stage renal insufficiency: <15 mL/min.
Key exclusion criteria (66 listed)
- Exclusion Criteria for subjects with mild, moderate and severe renal impairment:
- Have done kidney transplantation.
- Renal dialysis is required during the study.
- Those with allergic constitution, including those with a history of severe drug allergy or drug allergy, or known or suspected to be allergic to any component in the study drug.
- Urinary incontinence or anuria (eg <100ml/d).
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 |
|---|---|---|
| HR17031 injectionHR17031 injection; administered subcutaneously. | Drug | Cohort five: normal renal function, Cohort four: end-stage renal disease, Cohort one: mild renal insufficiency, Cohort three: severe renal insufficiency, Cohort two: moderate renal insufficiency |
Primary outcome
Pharmacokinetics parameters of INS068 and SHR20004: Cmax
Time frame: Based on pre-dose, 2-96 hours post-dose sampling times
Pharmacokinetics parameters of INS068 and SHR20004: AUC0-t
Time frame: Based on pre-dose, 2-96 hours post-dose sampling times
Pharmacokinetics parameters of INS068 and SHR20004: AUC0-inf
Time frame: Based on pre-dose, 2-96 hours post-dose sampling times
13 secondary outcomes
Pharmacokinetics parameters of INS068 and SHR20004: Tmax
Time frame: Based on pre-dose, 2-96 hours post-dose sampling times
Pharmacokinetics parameters of INS068 and SHR20004: T1/2
Time frame: Based on pre-dose, 2-96 hours post-dose sampling times
Pharmacokinetics parameters of INS068 and SHR20004: CL/F
Time frame: Based on pre-dose, 2-96 hours post-dose sampling times
Pharmacokinetics parameters of INS068 and SHR20004: Vz/F
Time frame: Based on pre-dose, 2-96 hours post-dose sampling times
Pharmacokinetics parameters of INS068 and SHR20004: Ae
Time frame: Based on pre-dose, 2-96 hours post-dose sampling times
Pharmacokinetics parameters of INS068 and SHR20004: fe
Time frame: Based on pre-dose, 2-96 hours post-dose sampling times
Pharmacokinetics parameters of INS068 and SHR20004: CLr
Time frame: Based on pre-dose, 2-96 hours post-dose sampling times
Average concentrations of INS068 and SHR20004 in dialysate of ESRD
Time frame: 0- 4 hours post-dose sampling times
Cumulative collection amount of INS068 and SHR20004 in dialysate of ESRD
Time frame: 0- 4 hours post-dose sampling times
Dialysis clearance of INS068 and SHR20004 in dialysate of ESRD
Time frame: 0- 4 hours post-dose sampling times
Binding rate of plasma protein of INS068 in serum and SHR20004 in plasma(fu)
Time frame: Based on pre-dose, 2-96 hours post-dose sampling times
The incidence and severity of adverse events/serious adverse events
Time frame: Based on pre-dose, 2-96 hours post-dose sampling times
ADA：anti-drug antibody
Time frame: Based on pre-dose、Day 5、Day14、Day 24 or early termination
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 22 May 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.
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 HR17031 injection in people with Improved Glycemic Control in Patients 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 16 inclusion and 66 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 22 May 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?
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?
Pharmacokinetics parameters of INS068 and SHR20004: Cmax (time frame: Based on pre-dose, 2-96 hours post-dose sampling times). The study lists 3 primary outcomes in all. 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 22 May 2026.