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Clinical efficacy and safety of simepaglutide in the treatment of T2DM combined with metabolic associated fatty liver disease (MAFLD): a prospective single-arm trial

Clinical efficacy and safety of simepaglutide in the treatment of T2DM combined with metabolic associated fatty liver disease (MAFLD): a prospective single-arm trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075216
Enrollment
Unknown
Registered
2023-08-30
Start date
2023-07-31
Completion date
Unknown
Last updated
2023-09-04

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

Conditions

metabolic associated fatty liver disease

Interventions

Experimental group:Simepaglutide

Sponsors

the Second People's Hospital of Chizhou
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: ? Voluntarily sign the informed consent before the start of the activities related to this trial, and be able to understand the procedures and methods of this trial, and be willing to strictly comply with the clinical trial protocol to complete this trial; ? Meet the diagnosis of T2DM; ? Meet the diagnosis of MAFLD: based on liver biopsy histology, imaging or blood biomarker tests suggesting the presence of fatty liver, and at the same time meet one of the following three conditions: overweight/obesity, type 2 diabetes mellitus, metabolic dysfunction. ? Age > 18 years; ? Renal function (eGFR) > 15 mL/min/1.73 m2 ? Participants need to minimize weight gain or promote weight loss as much as possible.

Exclusion criteria

Exclusion criteria: ? Other forms of diabetes are excluded; ? Subjects who may be allergic or intolerant to the study drug; ? Persons of childbearing age with a requirement for pregnancy (within one year), pregnant women and lactating women; ? Subjects with poor compliance ? Exclusion of viral hepatitis B or C, and excessive alcohol consumption (more than 30 g/day for men and 20 g/day for women); ? Suspected high risk of pancreatitis or previous history of pancreatitis.

Design outcomes

Primary

MeasureTime frame
Liver stiffness;

Secondary

MeasureTime frame
Routine blood test;Urine routine;Fasting blood glucose;HbA1c;2 hours postprandial blood glucose;Fasting C peptide;Fasting insulin (medicine);C-peptide 2 hours postprandial;2 hours postprandial insulin;Liver function;Renal function;Visceral fat index;Lipid accumulation products;Liver fibrosis index;CRP;

Countries

China

Contacts

Public Contactzhufengping; xuyiqi

the Second People's Hospital of Chizhou

zhufengping02@163.com+86 152 5699 1768

Outcome results

None listed

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