T2DMPhase 2NegentropyNCT07496177
A Mechanistic Study on the Effect of HTD1801 Versus Placebo on Kidney Function in Patients With Type 2 Diabetes and Chronic Kidney Disease.
A Phase 2 study testing HTD1801 in people with T2DM and CKD, run by Institute of Medicinal Biotechnology, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
Goal: The goal of this clinical trial is to learn if the investigational drug HTD1801 can slow the progression of kidney damage in adults diagnosed with both Type 2 Diabetes (T2DM) and Chronic Kidney Disease (CKD). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- HTD1801
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 9 Jul 2026to 30 Jun 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
- Subjects must meet all of the following criteria to be eligible for the study:
- Male or female, aged between 18 and 75 years (inclusive) at the time of signing the informed consent form.
- Clinically diagnosed with Type 2 Diabetes (T2DM) and Chronic Kidney Disease (CKD) before screening, evidenced by:
- A urine albumin-to-creatinine ratio (UACR) >200 mg/g on at least two separate occasions before screening.
- A clinical diagnosis of CKD (KDIGO stage G1 to G3b) for at least 3 months, and an estimated glomerular filtration rate (eGFR) between 30 and 120 ml/min/1.73 m² at screening (using the CKD-EPI creatinine-cystatin C formula).
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- Confirmed diagnosis of T2DM. If on medication for T2DM, the dose must have been stable for at least 3 months before enrollment. At screening, HbA1c must be ≤9%.
- At screening, on a stable, maximum tolerated or recommended dose of a RAAS inhibitor (e.g., valsartan, irbesartan) for at least 4 weeks. If not on a RAAS inhibitor, must be on at least one other stable, guideline-recommended kidney-protective drug (e.g., GLP-1RA, SGLT-2i, or non-steroidal MRA like finerenone) for at least 4 weeks.
- Body Mass Index (BMI) at screening between 18.5 kg/m² and 40 kg/m². Weight must be stable (no loss >10% in the 3 months before baseline) with no major lifestyle changes in the 3 months before screening.
- For women of childbearing potential and sexually active men with partners of childbearing potential: agreement to use highly effective contraception or practice abstinence throughout the study and for 30 days after the last dose.
- Able to understand, sign the informed consent form, and comply with the study protocol.
Who cannot join
- Exclusion Criteria Subjects who meet any of the following criteria are excluded from participation in the study. Exclusion criteria based on lab values refer to the most recent results obtained prior to randomization.
- Kidney Disease:
- Congenital or hereditary kidney diseases, including polycystic kidney disease, autoimmune kidney diseases (e.g., glomerulonephritis), or congenital urinary tract malformations.
- Currently receiving (or within the past 90 days) chronic or intermittent hemodialysis or peritoneal dialysis.
- Liver Disease:
- Clinically or histologically confirmed liver cirrhosis (Fibrosis Stage 4).
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- History of hepatic decompensation (e.g., ascites, hepatic encephalopathy, or variceal bleeding).
- Presence of the following acute or chronic liver diseases at screening: autoimmune hepatitis, primary biliary cholangitis, alcoholic liver disease, Wilson's disease, or drug-induced liver injury.
- Gastrointestinal Disease:
- History of gastric bypass surgery.
- History of peptic or gastrointestinal ulcer within 12 months prior to randomization.
- History of clinically active inflammatory bowel disease within 12 months prior to randomization.
- Severe gastrointestinal disease at screening that affects drug absorption, distribution, metabolism, or excretion, including chronic conditions causing recurrent diarrhea (e.g., irritable bowel syndrome, ulcerative colitis, Crohn's disease).
- Cardiovascular Disease:
- History of myocardial infarction, stroke, uncontrolled arrhythmia, unstable angina, coronary artery bypass grafting, or percutaneous coronary intervention within 6 months prior to screening.
- Current or previous history of New York Heart Association (NYHA) Class IV congestive heart failure.
- Planned coronary, carotid, or peripheral arterial revascularization.
- Uncontrolled hypertension despite antihypertensive therapy, defined as sustained SBP >150 mmHg and/or DBP >100 mmHg.
- Hematologic Disease:
- Hematologic disorders or any condition causing hemolysis or red blood cell instability at screening, including but not limited to: glucose-6-phosphate dehydrogenase (G-6-PD) deficiency, hemolytic anemia, iron deficiency anemia, aplastic anemia, chronic malaria, splenectomy, reticulocytopenia.
- Oncology:
- History of or current malignancy within the past 2 years, except for basal cell carcinoma or excised non-invasive squamous cell carcinoma of the skin.
- Current, planned, or anticipated treatment with radiotherapy, cytotoxic chemotherapy, or immunomodulators (e.g., interleukins, interferons). Long-term stable use of immunosuppressants is permitted if approved by the investigator.
- Diagnostic Assessments:
- Clinically significant laboratory abnormalities or ECG changes at screening, including but not limited to:
- Platelet count <150,000/mm³.
- International Normalized Ratio (INR) >1.3.
- Alkaline Phosphatase (ALP) >2 × Upper Limit of Normal (ULN).
- Total bilirubin >1.3 × ULN, unless the subject has Gilbert's syndrome.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥5 × ULN.
- Corrected QT interval (QTc) >450 ms for males or >470 ms for females (Fridericia's formula).
- Active severe infection requiring parenteral antibiotic or antifungal therapy within 30 days prior to or at screening.
- Evidence of the following viral infections at screening:
- Human Immunodeficiency Virus (HIV) infection: defined as positive HIV antibody.
- Syphilis infection: defined as positive Treponema pallidum antibody (TP-Ab).
- Active Hepatitis B Virus (HBV) infection: defined as positive Hepatitis B surface antigen (HBsAg) OR positive Hepatitis B core antibody (HBcAb) with HBV-DNA >500 IU/mL or >2000 copies/mL.
- Active Hepatitis C Virus (HCV) infection: defined as positive HCV antibody (HCV-Ab) with HCV-RNA above the ULN.
- Other:
- Major surgery within 30 days prior to screening.
- History of solid organ transplantation or being on a waiting list for such transplantation.
- Blood donation or blood loss ≥400 mL within 3 months prior to screening, or anticipated need for blood transfusion within 12 weeks after randomization.
- Known exposure to UDCA（Ursodeoxycholic Acid） or BBR（Berberine） within 3 months prior to screening, or known allergy to UDCA or BBR.
- History or evidence of Type 1 diabetes.
- Female subjects who are pregnant, breastfeeding, planning pregnancy, or of childbearing potential and not using highly effective contraception.
- Participation in any clinical study of an approved or investigational product within 30 days prior to screening.
- Any condition that, in the investigator's judgment, may jeopardize the subject's safety or compliance with the study protocol.
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
Weifang People's Hospital
Weifang, Shandong, 261000
Xingpeng Shi, 86-536-8192261, shixingpeng11@163.com
Haixia Liu
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Mechanistic Study to Evaluate the Effect of HTD1801 in Delaying the Progression of Renal Impairment in Patients With Type 2 Diabetes and Chronic Kidney Disease.
Goal: The goal of this clinical trial is to learn if the investigational drug HTD1801 can slow the progression of kidney damage in adults diagnosed with both Type 2 Diabetes (T2DM) and Chronic Kidney Disease (CKD).
Main Question it Aims to Answer:
Read more
▪ Does HTD1801 result in a greater reduction (or a smaller increase) in urine albumin-to-creatinine ratio (UACR) compared to a placebo?
Researchers will compare the group receiving HTD1801 to the group receiving a placebo to see if HTD1801 is more effective in slowing kidney function decline.
Participants will:
- Undergo screening tests to determine eligibility.
- Be randomly assigned to receive either HTD1801 capsules or matching placebo capsules twice daily for 12 weeks.
- Take the study medication twice daily for 12 weeks.
- Attend scheduled clinic visits (weekly for the first 4 weeks, then every 4 weeks) for assessments and check-ups.
- Have their safety monitored through reporting of any health changes and routine lab tests.
- Being tested
- HTD1801, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTD1801Drug
1000mg (as 4 capsules), twice a day for 12 weeks
placeboOther
4 placebo capsules, twice a day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| HTD1801 | Experimental | Patients take HTD1801 capsules, 1000mg (as 4 capsules), twice a day for 12 weeks. Receives: Drug: HTD1801 |
| placebo | Placebo comparator | Patients take 4 placebo capsules, twice a day for 12 weeks. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change in urine albumin-to-creatinine ratio (UACR) from baseline
Relative change in urine albumin-to-creatinine ratio (UACR) from baseline at Week 12
Measured: 12 weeks
Secondary outcomes (13)
Proportion of subjects achieving a ≥30% reduction in UACR and a <30% decline in eGFR
The percentage of patients who, at Week 12, had at least a 30% reduction in UACR and less than a 30% decline in eGFR.
Measured: 12 weeks
Change in albumin excretion rate from baseline.
Change in albumin excretion rate from baseline at Week 12.
Measured: 12 weeks
The percentage of patients who achieved at least a 30% and at least a 50% reduction in UACR.
The percentage of patients who, at Week 12, had at least a 30% and at least a 50% reduction in UACR.
Measured: 12 weeks
Change in log-transformed eGFR (based on the CKD-EPI combined creatinine-cystatin C equation) from baseline
Change in log-transformed eGFR (based on the CKD-EPI combined creatinine-cystatin C equation) from baseline at Week 12.
Measured: 12 weeks
Change in log-transformed eGFR (based on the CKD-EPI cystatin C equation) from baseline.
Change in log-transformed eGFR (based on the CKD-EPI cystatin C equation) from baseline at Week 12.
Measured: 12 weeks
Change in log-transformed eGFR (based on the CKD-EPI creatinine equation) from baseline.
Change in log-transformed eGFR (based on the CKD-EPI creatinine equation) from baseline at Week 12.
Measured: 12 weeks
Rate of change in eGFR slope (based on the CKD-EPI creatinine-cystatin C equation) from baseline.
Rate of change in eGFR slope (based on the CKD-EPI creatinine-cystatin C equation) from baseline at Week 12.
Measured: 12 weeks
Rate of change in eGFR slope (based on the CKD-EPI cystatin C equation) from baseline.
Rate of change in eGFR slope (based on the CKD-EPI cystatin C equation) from baseline at Week 12.
Measured: 12 weeks
Rate of change in eGFR slope (based on the CKD-EPI creatinine equation) from baseline.
Rate of change in eGFR slope (based on the CKD-EPI creatinine equation) from baseline at Week 12.
Measured: 12 weeks
Absolute and percent change in C-reactive protein (CRP) from baseline.
Absolute and percent change in C-reactive protein (CRP) from baseline at Week 12.
Measured: 12 weeks
Absolute and percent change in Gamma-glutamyl transferase (GGT) from baseline.
Absolute and percent change in Gamma-glutamyl transferase (GGT) from baseline at Week 12.
Measured: 12 weeks
Absolute and percent change in Hemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) from baseline.
Absolute and percent change in Hemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) from baseline at Week 12.
Measured: 12 weeks
Absolute and percent change in total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and non-high-density lipoprotein cholesterol (non-HDL-C) from baseline.
Absolute and percent change in total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and non-high-density lipoprotein cholesterol (non-HDL-C) from baseline at Week 12.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start9 Jul 2026
- Primary completion31 May 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T2DMStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Medicinal Biotechnology, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Weifang People's Hospital, Shenzhen HighTide Biopharmaceutical Ltd.
- Responsible party
- Sponsor
- Investigators
- Jiandong Jiang, Study director, Institute of Medicinal Biotechnology, Chinese Academy of Medical SciencesLulu Wang, Principal investigator, Institute of Medicinal Biotechnology, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496177
- Sponsor's protocol ID
- IMB-CT-2026-001
- Other IDs
- WFPH-2026-IIT-001
- Acronym
- Negentropy
- Status last verified
- Jul 2026
- First submitted
- 22 Mar 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Mechanistic Study to Evaluate the Effect of HTD1801 in Delaying the Progression of Renal Impairment in Patients With Type 2 Diabetes and Chronic Kidney Disease.
- ClinicalTrials.gov ID
- NCT07496177
- Acronym / sponsor ID
- Negentropy / IMB-CT-2026-001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Institute of Medicinal Biotechnology, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Weifang People's Hospital, Shenzhen HighTide Biopharmaceutical Ltd.
- Study start
- 9 Jul 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 27 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.
Goal: The goal of this clinical trial is to learn if the investigational drug HTD1801 can slow the progression of kidney damage in adults diagnosed with both Type 2 Diabetes (T2DM) and Chronic Kidney Disease (CKD).
Main Question it Aims to Answer:
▪ Does HTD1801 result in a greater reduction (or a smaller increase) in urine albumin-to-creatinine ratio (UACR) compared to a placebo?
Researchers will compare the group receiving HTD1801 to the group receiving a placebo to see if HTD1801 is more effective in slowing kidney function decline.
Participants will:
- Undergo screening tests to determine eligibility.
- Be randomly assigned to receive either HTD1801 capsules or matching placebo capsules twice daily for 12 weeks.
- Take the study medication twice daily for 12 weeks.
- Attend scheduled clinic visits (weekly for the first 4 weeks, then every 4 weeks) for assessments and check-ups.
- Have their safety monitored through reporting of any health changes and routine lab tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HTD1801 | Experimental | Drug: HTD1801Patients take HTD1801 capsules, 1000mg (as 4 capsules), twice a day for 12 weeks. |
| placebo | Placebo comparator | Other: placeboPatients take 4 placebo capsules, twice a day for 12 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- -
- Male or female, aged between 18 and 75 years (inclusive) at the time of signing the informed consent form.
- Clinically diagnosed with Type 2 Diabetes (T2DM) and Chronic Kidney Disease (CKD) before screening, evidenced by:
- Confirmed diagnosis of T2DM. If on medication for T2DM, the dose must have been stable for at least 3 months before enrollment. At screening, HbA1c must be ≤9%.
- At screening, on a stable, maximum tolerated or recommended dose of a RAAS inhibitor (e.g., valsartan, irbesartan) for at least 4 weeks. If not on a RAAS inhibitor, must be on at least one other stable, guideline-recommended kidney-protective drug (e.g., GLP-1RA, SGLT-2i, or non-steroidal MRA like finerenone) for at least 4 weeks.
Key exclusion criteria (46 listed)
- Exclusion Criteria Subjects who meet any of the following criteria are excluded from participation in the study. Exclusion criteria based on lab values refer to the most recent results obtained prior to randomization.
- Congenital or hereditary kidney diseases, including polycystic kidney disease, autoimmune kidney diseases (e.g., glomerulonephritis), or congenital urinary tract malformations.
- Currently receiving (or within the past 90 days) chronic or intermittent hemodialysis or peritoneal dialysis.
- Clinically or histologically confirmed liver cirrhosis (Fibrosis Stage 4).
- History of hepatic decompensation (e.g., ascites, hepatic encephalopathy, or variceal bleeding).
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 |
|---|---|---|
| HTD18011000mg (as 4 capsules), twice a day for 12 weeks | Drug | HTD1801 |
| placebo4 placebo capsules, twice a day for 12 weeks. | Other | placebo |
Primary outcome
Relative change in urine albumin-to-creatinine ratio (UACR) from baseline
Time frame: 12 weeks
Relative change in urine albumin-to-creatinine ratio (UACR) from baseline at Week 12
13 secondary outcomes
Proportion of subjects achieving a ≥30% reduction in UACR and a <30% decline in eGFR
Time frame: 12 weeks
Change in albumin excretion rate from baseline.
Time frame: 12 weeks
The percentage of patients who achieved at least a 30% and at least a 50% reduction in UACR.
Time frame: 12 weeks
Change in log-transformed eGFR (based on the CKD-EPI combined creatinine-cystatin C equation) from baseline
Time frame: 12 weeks
Change in log-transformed eGFR (based on the CKD-EPI cystatin C equation) from baseline.
Time frame: 12 weeks
Change in log-transformed eGFR (based on the CKD-EPI creatinine equation) from baseline.
Time frame: 12 weeks
Rate of change in eGFR slope (based on the CKD-EPI creatinine-cystatin C equation) from baseline.
Time frame: 12 weeks
Rate of change in eGFR slope (based on the CKD-EPI cystatin C equation) from baseline.
Time frame: 12 weeks
Rate of change in eGFR slope (based on the CKD-EPI creatinine equation) from baseline.
Time frame: 12 weeks
Absolute and percent change in C-reactive protein (CRP) from baseline.
Time frame: 12 weeks
Absolute and percent change in Gamma-glutamyl transferase (GGT) from baseline.
Time frame: 12 weeks
Absolute and percent change in Hemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) from baseline.
Time frame: 12 weeks
Absolute and percent change in total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and non-high-density lipoprotein cholesterol (non-HDL-C) from baseline.
Time frame: 12 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 15 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Jiandong Jiang study director
Institute of Medicinal Biotechnology, Chinese Academy of Medical Sciences
Lulu Wang principal investigator
Institute of Medicinal Biotechnology, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HTD1801 in people with T2DM and CKD, run by Institute of Medicinal Biotechnology, Chinese Academy of Medical Sciences 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 46 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 15 Jul 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. 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 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?
Contact Zhen Shen (86-10-63170236, j2025080011@pumc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative change in urine albumin-to-creatinine ratio (UACR) from baseline (time frame: 12 weeks). 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 15 Jul 2026.