Diabetes Mellitus, Type 2Phase 1NCT05427682
A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Pyroglutamate Rongliflozin Capsules in Subjects With Mild and Moderate Liver Damage
A Phase 1 study testing pyroglutamate rongliflozin capsules in people with Diabetes Mellitus, Type 2, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
Trial summary
To evaluate the pharmacokinetic characteristics of pyroglutamate rongliflozin capsules in subjects with mild and moderate liver damage and healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- pyroglutamate rongliflozin capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 19 Apr 2022to 10 Nov 2023
- 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
- Sign the informed consent form before the experiment, understand and abide by the research process, and participate voluntarily;
- Adult subjects between the ages of 18 and 70 (including boundary values), both male and female;
- Female subjects or male subjects with potential fertility must agree to use effective contraceptive methods (see Appendix 2 for specific contraceptive methods) from signing informed consent to taking the trial drug within 4 weeks to avoid pregnancy or make their partners pregnant.
- The following selection criteria are only applicable to healthy subjects with normal liver function (groups A and C): the gender and age (+ or - 5 years) of subjects in groups A and C are matched with subjects in groups B and D respectively;
- The following selection criteria are only applicable to healthy subjects with normal liver function (groups A and C): body mass index (BMI): 18-30kg/m2 (including cut-off value) [BMI=weight (kg)/height 2 (m2) )] (BMI matching between groups A and C and groups B and D is + or - 15%);
- The following selection criteria are only applicable to healthy subjects with normal liver function (groups A and C): medical history, physical examination, vital signs monitoring, electrocardiogram, laboratory tests (blood routine, urine routine, blood biochemistry, coagulation) Function), alpha-fetoprotein (AFP), abdominal B-ultrasound (liver, spleen, gallbladder, pancreas, kidneys), and chest radiographs have normal or abnormal results, but the investigator judges them to be of no clinical significance.
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- The following selection criteria are only applicable to subjects with liver dysfunction (groups B and D): for subjects with liver dysfunction without ascites, subclinical ascites, clinically mild and moderate ascites detected only by ultrasound or other imaging , Allow the body mass index (BMI) to be between 18-30 kg/m2 (including the critical value) [BMI= weight (kg) / height 2 (m2)];
- The following selection criteria are only applicable to subjects with liver dysfunction (groups B and D): according to the Child-Pugh classification (see Appendix 3) at the time of screening to evaluate the severity of patients with liver dysfunction in accordance with: (Grade A/Mild: Child -Pugh score 5 or 6 points; B grade/moderate: Child Pugh score 7-9 points);
- The following selection criteria are only applicable to subjects with liver dysfunction (groups B and D): combined with previous medical history, physical examination results, serological indicators (such as albumin, ALT, AST, bilirubin, prothrombin time, INR, etc.) ) And one of the following tests performed with standard diagnostic and treatment methods that meets the diagnostic basis for chronic liver disease: liver biopsy, computed tomography, magnetic resonance imaging, ultrasound, radioactive liver/spleen scan, laparoscopy;
- The following selection criteria are only applicable to subjects with liver damage (groups B and D): within 1 month before taking the test drug or 5 half-lives of the concomitant drug (whichever is longer) to the end of the study Those who have stable medication regimens for the treatment of liver dysfunction, liver disease complications and other concomitant diseases without adjustment (including the type of medication, dosage, or frequency of medication) or those who have not taken medication before enrollment; however, the study doctor's judgment does not affect Except for the adjustment of subject safety and pharmacokinetic endpoints;
- The following selection criteria are only applicable to subjects with liver dysfunction (groups B and D): the investigator judges that the liver function status of the subjects is stable and will not deteriorate significantly during the period from 1 month before taking the test drug to the end of the study By.
Who cannot join
- The subject has a history of severe allergies or allergies to the test drug and any of its components or related excipients;
- People with history of gastrointestinal or kidney disease or surgery (except for uncomplicated appendicitis resection and hernia repair) that may potentially affect the absorption, distribution, metabolism, and excretion of the test drug in the 6 months prior to screening, or the presence can make compliance People with reduced disease;
- The researcher judged that he currently has bleeding disorders, such as gastric and duodenal ulcers;
- People with a history of liver cancer or other malignant tumors before signing the informed consent form [exceptions: specific cancers (basal cell carcinoma of the skin, squamous cell carcinoma, or cervical carcinoma in situ, etc.) that are surgically removed and completely cured can be selected] or are currently assessed for existence People with potential malignant tumors;
- Patients with a history of repeated urinary tract infections or/and genital infections within 6 months before screening (recurrent urinary tract infection is defined as: repeated urinary tract infections > or = 2 times within 6 months, or repeated urinary tract infections in the past 12 months Infection > or =3 times);
- People with a history of recurring severe unconscious hypoglycemia (repeated severe hypoglycemia is defined as: 2 severe neurological symptoms in 4 weeks, hypoglycemia requiring the assistance of others to treat, or 2 blood glucose in 4 weeks< 3.0 mmol/L, or blood glucose < or = 3.9 mmol/L > or =3 times detected within 1 week);
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- People with a history of alcoholism (alcoholism is defined as: drinking 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine) or those who have a positive alcohol breath test during the screening period;
- Those who have a history of drug abuse or have used drugs within 2 years before screening or those who have a positive urine drug screening during the screening period;
- Those who smoked more than 5 cigarettes a day in the 3 months before screening or who could not give up smoking from signing informed consent to leaving the group;
- Treponema pallidum antibody and/or human immunodeficiency virus (HIV) antibody test results are positive;
- Have taken food or drinks that affect CYP3A4 metabolic enzymes, such as grapefruit or drinks containing grapefruit within 7 days before the first medication;
- Consume chocolate, any food or drink that contains caffeine or is rich in xanthine within 72 hours before the first medication;
- Have taken any alcohol-containing products within 48 hours before the first medication;
- Those who donated blood > or = 400 mL or a large amount of blood loss within 3 months before screening, or who have a history of blood transfusion within 1 month before screening, or who plan to donate blood within 1 month after the end of the test;
- Have taken similar SGLT-2 inhibitor drugs within 14 days before screening or participated in other clinical trials within 3 months before screening (if the subject withdrew from the study before treatment, that is, not randomized or received treatment, they can be included in the group Research);
- The subject is breastfeeding or the result of serum pregnancy is positive;
- Take the prohibited concomitant medications within 1 month before taking the trial drug or within the 5 half-life period of the concomitant medication (whichever is the longer) to the end of the study (see Chapter 5.5.1 for details);
- The investigator believes that there are other subjects who are not suitable for participating in this trial (such as inability to tolerate oral drugs, poor peripheral venous access conditions, or significant risks to the subjects, etc.).
- The following exclusion criteria are only applicable to healthy subjects with normal liver function (groups A and C): hepatitis B surface antigen (HBsAg) and hepatitis C virus (HCV) antibody test results are positive;
- The following exclusion criteria are only applicable to healthy subjects with normal liver function (groups A and C): the subjects have the following clinically significant diseases before screening, including but not limited to gastrointestinal tract, kidney, liver, nerve, blood , Endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases;
- The following exclusion criteria are only applicable to healthy subjects with normal liver function (groups A and C): any prescription drugs, non-prescription drugs, any vitamin products or Chinese herbal medicines have been taken within 2 weeks before the first medication.
- The following exclusion criteria are only applicable to subjects with liver dysfunction (groups B and D): the laboratory test results at the time of screening meet any of the following: a) ALT>10×ULN; b) absolute value of neutrophils <0.75 ×109/L; c) platelets <50×109/L (except for cases in a stable state as judged by the investigator); d) hemoglobin <60 g/L; e) AFP>100 ng/mL; if 20 ng/ mL=AFP=100 ng/mL, liver ultrasonography or other imaging examinations (CT, MRI, etc.) are required to exclude subjects suspected of hepatocellular carcinoma; f) Estimated using the modified dietary test for kidney disease (MDRD) formula Glomerular filtration rate (eGFR) <60 mL/min/1.73m2 (for eGFR estimation formula, please refer to Appendix 4).
- The following exclusion criteria are only applicable to subjects with liver dysfunction (groups B and D): those with cardiovascular and cerebrovascular events within 6 months before screening, including stroke (except for lacunar infarction), acute myocardial infarction, cardiac Dysfunction (New York College of Cardiology [NYHA] Grade III or IV, see Appendix 6), transient ischemic attack, coronary intervention (including stent thrombosis), peripheral vascular intervention, unstable angina, etc.;
- The following exclusion criteria are only applicable to subjects with liver dysfunction (groups B and D): subjects who have severe esophageal and gastric varices or have undergone portal venous shunt, including transjugular intrahepatic portosystemic shunt Surgery (TIPS);
- The following exclusion criteria are only applicable to subjects with liver dysfunction (groups B and D): subjects suffering from biliary obstruction and other diseases that affect bile excretion or drug-induced liver injury;
- The following exclusion criteria are only applicable to subjects with liver damage (groups B and D): subjects suffering from liver failure or severe complications of liver cirrhosis (such as spontaneous bacterial peritonitis, bleeding from esophageal and gastric fundus veins, liver and kidney Syndrome, etc.);
- The following exclusion criteria are only applicable to subjects with liver damage (groups B and D): a history of liver transplantation;
- The following exclusion criteria are only applicable to subjects with liver damage (groups B and D): any prescription drugs, over-the-counter drugs, and any vitamins other than those used to treat liver damage or their comorbidities have been used within 2 weeks before the first medication Products or Chinese herbal medicine;
- The following exclusion criteria are only applicable to subjects with liver dysfunction (groups B and D): the investigator is based on the subject's medical history, physical examination, vital signs, laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function) , AFP, 12-lead electrocardiogram, EEG, and judge that the subject has other clinically significant abnormalities (except for abnormal indexes related to liver function, HBsAg and HCV antibody positive), such as uncontrolled heart, breathing, gastrointestinal Tract, blood, nerve, or other diseases that may interfere with the subject's treatment, evaluation, or compliance with the research protocol, and those who are not suitable for inclusion in this study will also be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Non-randomized, Open, Single-dose Clinical Trial to Evaluate the Pharmacokinetics and Safety of Pyroglutamate Rongliflozin Capsules in Subjects With Mild and Moderate Liver Damage
To evaluate the pharmacokinetic characteristics of pyroglutamate rongliflozin capsules in subjects with mild and moderate liver damage and healthy subjects
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- pyroglutamate rongliflozin capsules
- 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.
pyroglutamate rongliflozin capsulesDrug
Subjects will receive one 50mg capsule on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Group A (normal liver function) | Experimental | Each subject will receive a single dose of rongliflozin on Day 1 Receives: Drug: pyroglutamate rongliflozin capsules |
| Group B (mild liver damage) | Experimental | Each subject will receive a single dose of rongliflozin on Day 1 Receives: Drug: pyroglutamate rongliflozin capsules |
| Group C (normal liver function) | Experimental | Each subject will receive a single dose of rongliflozin on Day 1 Receives: Drug: pyroglutamate rongliflozin capsules |
| Group D (moderate liver damage) | Experimental | Each subject will receive a single dose of rongliflozin on Day 1 Receives: Drug: pyroglutamate rongliflozin capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum plasma concentration of study drugs
Measured: 0 hour（pre-dose） to 96 hours after administration
AUC
Maximum plasma concentration of study drugs
Measured: 0 hour（pre-dose） to 96 hours after administration
Adverse Events
Incidence of adverse events
Measured: Day -1 (Baseline) to Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start19 Apr 2022
- Primary completion10 Nov 2023
- Study completion10 Nov 2023
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 Sunshine Lake Pharma 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
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427682
- Sponsor's protocol ID
- DJT1116PG-DM-105
- Status last verified
- Jun 2022
- First submitted
- 17 Jun 2022
- Last updated
- 5 May 2026
- 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 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Non-randomized, Open, Single-dose Clinical Trial to Evaluate the Pharmacokinetics and Safety of Pyroglutamate Rongliflozin Capsules in Subjects With Mild and Moderate Liver Damage
- ClinicalTrials.gov ID
- NCT05427682
- Acronym / sponsor ID
- DJT1116PG-DM-105
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 10 Nov 2023 (actual)
- Study completion
- 10 Nov 2023 (actual)
- First posted
- 22 Jun 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.
To evaluate the pharmacokinetic characteristics of pyroglutamate rongliflozin capsules in subjects with mild and moderate liver damage and healthy subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A (normal liver function) | Experimental | Drug: pyroglutamate rongliflozin capsulesEach subject will receive a single dose of rongliflozin on Day 1 |
| Group B (mild liver damage) | Experimental | Drug: pyroglutamate rongliflozin capsulesEach subject will receive a single dose of rongliflozin on Day 1 |
| Group C (normal liver function) | Experimental | Drug: pyroglutamate rongliflozin capsulesEach subject will receive a single dose of rongliflozin on Day 1 |
| Group D (moderate liver damage) | Experimental | Drug: pyroglutamate rongliflozin capsulesEach subject will receive a single dose of rongliflozin on Day 1 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Sign the informed consent form before the experiment, understand and abide by the research process, and participate voluntarily;
- Adult subjects between the ages of 18 and 70 (including boundary values), both male and female;
- Female subjects or male subjects with potential fertility must agree to use effective contraceptive methods (see Appendix 2 for specific contraceptive methods) from signing informed consent to taking the trial drug within 4 weeks to avoid pregnancy or make their partners pregnant.
- The following selection criteria are only applicable to healthy subjects with normal liver function (groups A and C): the gender and age (+ or - 5 years) of subjects in groups A and C are matched with subjects in groups B and D respectively;
- The following selection criteria are only applicable to healthy subjects with normal liver function (groups A and C): body mass index (BMI): 18-30kg/m2 (including cut-off value) [BMI=weight (kg)/height 2 (m2) )] (BMI matching between groups A and C and groups B and D is + or - 15%);
Key exclusion criteria (29 listed)
- The subject has a history of severe allergies or allergies to the test drug and any of its components or related excipients;
- People with history of gastrointestinal or kidney disease or surgery (except for uncomplicated appendicitis resection and hernia repair) that may potentially affect the absorption, distribution, metabolism, and excretion of the test drug in the 6 months prior to screening, or the presence can make compliance People with reduced disease;
- The researcher judged that he currently has bleeding disorders, such as gastric and duodenal ulcers;
- People with a history of liver cancer or other malignant tumors before signing the informed consent form [exceptions: specific cancers (basal cell carcinoma of the skin, squamous cell carcinoma, or cervical carcinoma in situ, etc.) that are surgically removed and completely cured can be selected] or are currently assessed for existence People with potential malignant tumors;
- Patients with a history of repeated urinary tract infections or/and genital infections within 6 months before screening (recurrent urinary tract infection is defined as: repeated urinary tract infections > or = 2 times within 6 months, or repeated urinary tract infections in the past 12 months Infection > or =3 times);
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 |
|---|---|---|
| pyroglutamate rongliflozin capsulesSubjects will receive one 50mg capsule on Day 1 | Drug | Group A (normal liver function), Group B (mild liver damage), Group C (normal liver function), Group D (moderate liver damage) |
Primary outcome
Cmax
Time frame: 0 hour（pre-dose） to 96 hours after administration
Maximum plasma concentration of study drugs
AUC
Time frame: 0 hour（pre-dose） to 96 hours after administration
Maximum plasma concentration of study drugs
Adverse Events
Time frame: Day -1 (Baseline) to Day 5
Incidence of adverse events
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 5 May 2026.
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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 pyroglutamate rongliflozin capsules in people with Diabetes Mellitus, Type 2, run by Sunshine Lake Pharma 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 11 inclusion and 29 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 5 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?
Cmax (time frame: 0 hour（pre-dose） to 96 hours after administration). 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 5 May 2026.