Skip to content

Efficacy and Safety of Benaglutide on Non-alcoholic Steatohepatitis in T2DM Patients: A Randomised Open Clinical Trial

Efficacy and Safety of Benaglutide on Non-alcoholic Steatohepatitis in T2DM Patients: A Randomised Open Clinical Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023611
Enrollment
Unknown
Registered
2019-06-04
Start date
2018-10-25
Completion date
Unknown
Last updated
2019-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nonalcoholic hepatosteatotis

Interventions

Experimental group:Benaglutide

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Men or woman aged 18 years and over; 2. Subjescts had been diagnosed with type 2 diabetes; 3. Hepatic fat content is >15% by 1H MRS within one month; 4. Elevated serum hepatic enzymes or hepatic fibrosis defined by Fibroscan.

Exclusion criteria

Exclusion criteria: 1. Alcohol excessive drinker defined as greater than 140g/w for men and 70g/w for women in the past 6 months; 2. Other liver diseases defined as alcoholic fatty liver disease, acute viral hepatitis, drug or auto immune hepatitis(AMA, SMA, ANA), cirrosis, liver cancer; 3. Biliary diseases including obstructive biliary diseases; 4. Endocrine disorders including hyperthyroidism, hypothyroidism, Cushing disease; 5. Poorly controlled diabetes defined as HbA1c greater than 9.5% within 3 months or use of anti-diabetic drugs such as pioglitazone, GLP-1RA,DPP-IV inhibitors; 6. Chronic kidney diseases or severe kidney injury defined as serum creatinine greater than 2.0mg/dL; 7. Serum ALT greater than 3 folds of normal range; 8. Poor health state with lifespan less than 5 years; 9. Pregnant women or plan to be pregnant in the near future; 10. Be unable to complete the study; 11. Continuous use of those drugs potentially associated with hepatitis including cortisone, methotrexate; 12. Participating other clinical trials within 4 weeks; 13. Be unable to sign consent forms.

Design outcomes

Primary

MeasureTime frame
The change of intrahepatic triglyceride contents and hepatic stiffness;

Secondary

MeasureTime frame
Body weight, waist circumference, fasting plasma glucose, HOMA-IR;Change of hepatic enzymes;

Countries

China

Contacts

Public ContactXiaoying Li

Zhongshan Hospital, Fudan University

xiaoying_li@hotmail.com+86 13651913857

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026