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The Improvement Effect of Henggliejin on Fatty Liver in Type 2 Diabetes Patients With Nonalcoholic Fatty Liver: | Clinical Trials | Clareo Health

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The Improvement Effect of Henggliejin on Fatty Liver in Type 2 Diabetes Patients With Nonalcoholic Fatty Liver:

The Improvement Effect of Henggliejin on Fatty Liver in Type 2 Diabetes Patients With Nonalcoholic Fatty Liver: a Multicenter, Prospective, Single Arm Clinical Study

NCT07198516•Fujian Medical University Union Hospital

View on ClinicalTrials.gov

Summary

To evaluate the effect and safety of Henggliejin on fatty liver in type 2 diabetes patients with nonalcoholic fatty liver disease

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•(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

Exclusion Criteria

•(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:
•1. Alanine aminotransferase\>2.0 times ULN and/or aspartate aminotransferase\>2.0 times ULN and/or total bilirubin\>2.0 times ULN
•2. Blood ketones\>ULN
•3. eGFR \<30ml/min/1.73 m2； Note: The formula for calculating eGFR is CKD-EPI (which can be calculated within the WeChat mini program)
•4. 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

Key Dates

Start Date

November 1, 2025

Primary Completion Date

September 1, 2026

Completion Date

December 31, 2026

Last Updated

September 30, 2025

Enrollment

149

ESTIMATED participants

Conditions

NAFLDDiabete Type 2

Interventions

Addition of Hengge Liejing treatment for 48 weeks

DRUG

Study of the Efficacy and Safety of Nicotinamide in Patients With Liver Fibrosis (NICOFIB)

NCT06599918

Fatty LiverObesity+4 more

View study

RECRUITINGNA

Non-Invasive Diagnostic Tests for MASLD in Pediatric Population

NCT06218589

Metabolic Dysfunction Associated Steatotic Liver DiseaseNon-Alcoholic Fatty Liver Disease (NAFLD)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Improvement Effect of Henggliejin on Fatty Liver in Type 2 Diabetes Patients With Nonalcoholic Fatty Liver:

Inclusion Criteria

Exclusion Criteria

Study of the Efficacy and Safety of Nicotinamide in Patients With Liver Fibrosis (NICOFIB)

Non-Invasive Diagnostic Tests for MASLD in Pediatric Population

Evaluation of a New Ultrasound System for the Non-invasive Assessment of Liver Steatosis in MASLD/MASH Patients

OneSTOP (One-Stop Telehealth Obesity Program) for Multidisciplinary Weight Management and Related Comorbidities

Prevalence of Non-Alcoholic Fatty Liver Disease in Inflammatory Bowel Disease Patients

Safety, Tolerability and Preliminary Efficacy of Sublingual Liraglutide in Patients With Type 2 Diabetes Mellitus