NAFLDEarly Phase 1NCT07198516
The Improvement Effect of Henggliejin on Fatty Liver in Type 2 Diabetes Patients With Nonalcoholic Fatty Liver:
A Early Phase 1 study testing Addition of Hengge Liejing treatment for 48 weeks in people with NAFLD and Diabete Type 2, run by Fujian Medical University Union Hospital.
Trial summary
To evaluate the effect and safety of Henggliejin on fatty liver in type 2 diabetes patients with nonalcoholic fatty liver disease Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- NAFLD, Diabete Type 2
- What is being tested?
- Addition of Hengge Liejing treatment for 48 weeks
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2025to 31 Dec 2026
- Phase
- Early 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Type 2 diabetes diagnosed according to WHO diagnostic criteria, age ≥ 18 years old, ≤ 70 years old, gender unlimited (2) Diagnosed with NAFLD according to the criteria of the "Guidelines for the Prevention and Treatment of Non alcoholic Fatty Liver Disease (2018 Updated Edition)" (3) Before screening, patients with type 2 diabetes who were treated with single or combined drugs of stable dose (except TZDs, SGLT2i, GLP-1RA, insulin and GKAs) for ≥ 8 weeks and had poor blood glucose control, 7% ≤ HbA1c ≤ 10% (4)BMI≥24 kg/m2 (5) Can understand the content and methods of this study and voluntarily sign an informed consent form
Who cannot join
- (1) Patients with diabetes other than type 2 diabetes, including type 1 diabetes and gestational diabetes (2) Acute diabetes complications such as diabetes ketosis or ketoacidosis, diabetes hypertonic state, diabetes lactic acidosis or serious chronic diabetes complications (3) Individuals with a history of recurrent urinary tract infections and/or genital infections (as determined by clinical physicians) (4) Alcoholic liver disease (alcohol consumption equivalent to less than 30 g/d for males and less than 20 g/d for females in the past two years) (5) Exclude other liver diseases, such as chronic hepatitis B, chronic hepatitis C, primary cholestatic cirrhosis, ballistic obstructive diseases, drug-induced liver damage, hemochromatosis, hepatolenticular deformation, autoimmune hepatitis (6) Combined cirrhosis, combined liver cancer, HIV positive, drug abuse (7) Drugs (tamoxifen, amiodarone, sodium valproate, methotrexate, glucocorticoid, etc.), total parenteral nutrition, inflammatory bowel disease, celiac disease, hypothyroidism, Cushing's syndrome, β - lipoprotein deficiency, lipoatrophic diabetes, Mauriac syndrome, and other special conditions leading to fatty liver (8) Serious trauma or acute infection that may affect blood glucose control occurred within 4 weeks (9) Individuals who have experienced decompensated heart failure (NYHA grades III and IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, severe arrhythmia, or have undergone cardiac surgery or vascular reconstruction (including coronary artery bypass grafting or percutaneous coronary intervention) within 6 months (10) There are obvious blood system diseases (such as aplastic anemia, myelodysplastic syndrome) or any diseases that cause hemolysis or red blood cell instability (such as malaria, hemolytic anemia) (11) Individuals with severe chronic gastrointestinal diseases, or those who have received treatment that may affect drug absorption (such as gastrointestinal surgery) (12) Uncontrolled hyperthyroidism (13) Individuals with mental or neurological disorders who are unwilling to communicate or unable to fully understand and collaborate (14) Pregnant or lactating women (15) There are any laboratory test indicators that meet the following standards:
- Alanine aminotransferase>2.0 times ULN and/or aspartate aminotransferase>2.0 times ULN and/or total bilirubin>2.0 times ULN
- Blood ketones>ULN
- eGFR <30ml/min/1.73 m2； Note: The formula for calculating eGFR is CKD-EPI (which can be calculated within the WeChat mini program)
- Blood creatine kinase>3 times ULN (16) In addition to the above, the researchers have determined that patients who are not suitable to participate in this clinical trial
About this study
Official title: The Improvement Effect of Henggliejin on Fatty Liver in Type 2 Diabetes Patients With Nonalcoholic Fatty Liver: a Multicenter, Prospective, Single Arm Clinical Study
To evaluate the effect and safety of Henggliejin on fatty liver in type 2 diabetes patients with nonalcoholic fatty liver disease
- Conditions
- NAFLD, Diabete Type 2
- Being tested
- Addition of Hengge Liejing treatment for 48 weeks
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Addition of Hengge Liejing treatment for 48 weeksDrug
Treatment with Hengge Liejing for 48 weeks, drug formulation: tablets. Dosage: 10mg qd, taken orally in the morning, before or after breakfast, for 48 consecutive weeks
| Study group | Role | What they receive |
|---|---|---|
| Add Henggelijing treatment for T2DM patients with NAFLD and oral administration of three or fewer hy | Experimental | Not described Receives: Drug: Addition of Hengge Liejing treatment for 48 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
After 48 weeks of Henggeleijing treatment, FIB-4 index values
Measured: From enrollment to the end of treatment at 48 weeks
Secondary outcomes (15)
Four indicators of liver fibrosis after 48 weeks of Henggelijing treatment
FIB-4 index is a non-invasive liver fibrosis assessment tool based on blood indicators and age, mainly used to evaluate the risk of liver fibrosis progression in patients with chronic liver disease. Calculation formula: FIB-4=(age x AST)/(platelet count x √ ALT). When calculating, please note that the units of AST and ALT should be U/L, and the unit of platelet count should be 10 ^ 9/L。 When FIB-4<1.3, it indicates no significant liver fibrosis When 1.3 ≤ FIB-4 ≤ 3.25, there may be moderate liver fibrosis When FIB-4>3.25, there is a high suspicion of advanced liver fibrosis or cirrhosis
Measured: From enrollment to the end of treatment at 48 weeks"
Improvement rate of FIB-4 index (FIB-4 index improvement defined as a decrease of ≥ 10% from baseline) after 48 weeks of treatment with Henggeleijing
Measured: From enrollment to the end of treatment at 48 weeks"
Changes in visceral fat content compared to baseline after 48 weeks of treatment with Henggelijing
Using DUAL bioimpedance method to identify adipose tissue and subcutaneous fat, and safely and conveniently calculate visceral fat area
Measured: From enrollment to the end of treatment at 48 weeks
The results of glycated hemoglobin after 12, 24, and 48 weeks of Henggeleijing treatment
Measured: From enrollment to the end of treatment at 48 weeks
The proportion of HbA1c<7% and HbA1c<6.5% after 12, 24, and 48 weeks of treatment with Henggeleijing
Measured: From enrollment to the end of treatment at 48 weeks
Changes in fasting plasma glucose levels compared to baseline after 12, 24, 36, and 48 weeks of treatment with Henggeleijing
Measured: From enrollment to the end of treatment at 48 weeks
After 12, 24, 36, and 48 weeks of treatment with Henggeleijing, changes in liver enzyme indicators (including AST, ALT, GGT) compared to baseline were observed
Measured: From enrollment to the end of treatment at 48 weeks
After 48 weeks of Henggeleijing treatment, the fat content of the endocardial fat pad
Cardiac ultrasound detection of fat content in endocardial fat pad
Measured: From enrollment to the end of treatment at 48 weeks
Changes in C-peptide levels compared to baseline after 12, 24, and 48 weeks of treatment with Henggelijing
Measured: From enrollment to the end of treatment at 48 weeks
Changes in fasting insulin levels compared to baseline after 12, 24, and 48 weeks of treatment with Henggelijing
Measured: From enrollment to the end of treatment at 48 weeks
Changes in HOMA-IR index compared to baseline after 12, 24, and 48 weeks of treatment with Henggeleijing
Measured: From enrollment to the end of treatment at 48 weeks
Changes in fasting body weight compared to baseline after 12, 24, 36, and 48 weeks of treatment with Henggeleijing
Measured: From enrollment to the end of treatment at 48 weeks
Blood pressure changes compared to baseline after 12, 24, 36, and 48 weeks of treatment with Henggeleijing
Measured: From enrollment to the end of treatment at 48 weeks
Changes in blood lipid profile (including LDL-C, TG, HDL, TC) compared to baseline after 12, 24, 36, and 48 weeks of treatment with Henggeleijing
Measured: From enrollment to the end of treatment at 48 weeks
FIB-4 index after 12,and 24 weeks of Henggeleijing treatment
Measured: From enrollment to the end of treatment at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start1 Nov 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union HospitalThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 149 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198516
- Sponsor's protocol ID
- 2024XHYG0020
- Status last verified
- Aug 2025
- First submitted
- 17 Aug 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Improvement Effect of Henggliejin on Fatty Liver in Type 2 Diabetes Patients With Nonalcoholic Fatty Liver: a Multicenter, Prospective, Single Arm Clinical Study
- ClinicalTrials.gov ID
- NCT07198516
- Acronym / sponsor ID
- 2024XHYG0020
- Conditions
- NAFLD, Diabete Type 2
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 149 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Sep 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.
To evaluate the effect and safety of Henggliejin on fatty liver in type 2 diabetes patients with nonalcoholic fatty liver disease
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Add Henggelijing treatment for T2DM patients with NAFLD and oral administration of three or fewer hy | Experimental | Drug: Addition of Hengge Liejing treatment for 48 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (1) Type 2 diabetes diagnosed according to WHO diagnostic criteria, age ≥ 18 years old, ≤ 70 years old, gender unlimited (2) Diagnosed with NAFLD according to the criteria of the "Guidelines for the Prevention and Treatment of Non alcoholic Fatty Liver Disease (2018 Updated Edition)" (3) Before screening, patients with type 2 diabetes who were treated with single or combined drugs of stable dose (except TZDs, SGLT2i, GLP-1RA, insulin and GKAs) for ≥ 8 weeks and had poor blood glucose control, 7% ≤ HbA1c ≤ 10% (4)BMI≥24 kg/m2 (5) Can understand the content and methods of this study and voluntarily sign an informed consent form
Key exclusion criteria (5 listed)
- (1) Patients with diabetes other than type 2 diabetes, including type 1 diabetes and gestational diabetes (2) Acute diabetes complications such as diabetes ketosis or ketoacidosis, diabetes hypertonic state, diabetes lactic acidosis or serious chronic diabetes complications (3) Individuals with a history of recurrent urinary tract infections and/or genital infections (as determined by clinical physicians) (4) Alcoholic liver disease (alcohol consumption equivalent to less than 30 g/d for males and less than 20 g/d for females in the past two years) (5) Exclude other liver diseases, such as chronic hepatitis B, chronic hepatitis C, primary cholestatic cirrhosis, ballistic obstructive diseases, drug-induced liver damage, hemochromatosis, hepatolenticular deformation, autoimmune hepatitis (6) Combined cirrhosis, combined liver cancer, HIV positive, drug abuse (7) Drugs (tamoxifen, amiodarone, sodium valproate, methotrexate, glucocorticoid, etc.), total parenteral nutrition, inflammatory bowel disease, celiac disease, hypothyroidism, Cushing's syndrome, β - lipoprotein deficiency, lipoatrophic diabetes, Mauriac syndrome, and other special conditions leading to fatty liver (8) Serious trauma or acute infection that may affect blood glucose control occurred within 4 weeks (9) Individuals who have experienced decompensated heart failure (NYHA grades III and IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, severe arrhythmia, or have undergone cardiac surgery or vascular reconstruction (including coronary artery bypass grafting or percutaneous coronary intervention) within 6 months (10) There are obvious blood system diseases (such as aplastic anemia, myelodysplastic syndrome) or any diseases that cause hemolysis or red blood cell instability (such as malaria, hemolytic anemia) (11) Individuals with severe chronic gastrointestinal diseases, or those who have received treatment that may affect drug absorption (such as gastrointestinal surgery) (12) Uncontrolled hyperthyroidism (13) Individuals with mental or neurological disorders who are unwilling to communicate or unable to fully understand and collaborate (14) Pregnant or lactating women (15) There are any laboratory test indicators that meet the following standards:
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 |
|---|---|---|
| Addition of Hengge Liejing treatment for 48 weeksTreatment with Hengge Liejing for 48 weeks, drug formulation: tablets. Dosage: 10mg qd, taken orally in the morning, before or after breakfast, for 48 consecutive weeks | Drug | Add Henggelijing treatment for T2DM patients with NAFLD and oral administration of three or fewer hy |
Primary outcome
After 48 weeks of Henggeleijing treatment, FIB-4 index values
Time frame: From enrollment to the end of treatment at 48 weeks
15 secondary outcomes
Four indicators of liver fibrosis after 48 weeks of Henggelijing treatment
Time frame: From enrollment to the end of treatment at 48 weeks"
Improvement rate of FIB-4 index (FIB-4 index improvement defined as a decrease of ≥ 10% from baseline) after 48 weeks of treatment with Henggeleijing
Time frame: From enrollment to the end of treatment at 48 weeks"
Changes in visceral fat content compared to baseline after 48 weeks of treatment with Henggelijing
Time frame: From enrollment to the end of treatment at 48 weeks
The results of glycated hemoglobin after 12, 24, and 48 weeks of Henggeleijing treatment
Time frame: From enrollment to the end of treatment at 48 weeks
The proportion of HbA1c<7% and HbA1c<6.5% after 12, 24, and 48 weeks of treatment with Henggeleijing
Time frame: From enrollment to the end of treatment at 48 weeks
Changes in fasting plasma glucose levels compared to baseline after 12, 24, 36, and 48 weeks of treatment with Henggeleijing
Time frame: From enrollment to the end of treatment at 48 weeks
After 12, 24, 36, and 48 weeks of treatment with Henggeleijing, changes in liver enzyme indicators (including AST, ALT, GGT) compared to baseline were observed
Time frame: From enrollment to the end of treatment at 48 weeks
After 48 weeks of Henggeleijing treatment, the fat content of the endocardial fat pad
Time frame: From enrollment to the end of treatment at 48 weeks
Changes in C-peptide levels compared to baseline after 12, 24, and 48 weeks of treatment with Henggelijing
Time frame: From enrollment to the end of treatment at 48 weeks
Changes in fasting insulin levels compared to baseline after 12, 24, and 48 weeks of treatment with Henggelijing
Time frame: From enrollment to the end of treatment at 48 weeks
Changes in HOMA-IR index compared to baseline after 12, 24, and 48 weeks of treatment with Henggeleijing
Time frame: From enrollment to the end of treatment at 48 weeks
Changes in fasting body weight compared to baseline after 12, 24, 36, and 48 weeks of treatment with Henggeleijing
Time frame: From enrollment to the end of treatment at 48 weeks
Blood pressure changes compared to baseline after 12, 24, 36, and 48 weeks of treatment with Henggeleijing
Time frame: From enrollment to the end of treatment at 48 weeks
Changes in blood lipid profile (including LDL-C, TG, HDL, TC) compared to baseline after 12, 24, 36, and 48 weeks of treatment with Henggeleijing
Time frame: From enrollment to the end of treatment at 48 weeks
FIB-4 index after 12,and 24 weeks of Henggeleijing treatment
Time frame: From enrollment to the end of treatment at 24 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 30 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Addition of Hengge Liejing treatment for 48 weeks in people with NAFLD and Diabete Type 2, run by Fujian Medical University Union Hospital.
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 1 inclusion and 5 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: opening soon, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
After 48 weeks of Henggeleijing treatment, FIB-4 index values (time frame: From enrollment to the end of treatment at 48 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 30 Sep 2025.