Effects of iGlarLixi Versus iGlar on Liver Fat Content in Patients With Type 2 Diabetes Mellitus With Metabolic Dysfunction-associated Steatotic Liver Disease: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Absolute change from baseline to Week 12 in hepatic fat fraction
研究概览
简要总结
This is a single-center, randomized, open-label, controlled clinical trial to compare the effects of a fixed-ratio combination of insulin glargine 100 U/mL plus lixisenatide (iGlarLixi) versus insulin glargine 100 U/mL (iGlar) on liver fat content in patients with Type 2 Diabetes (T2DM) and Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). The study includes a 12-week treatment period.
详细描述
This study is designed as a single-center, randomized, open-label, parallel controlled trial. A total of 36 participants with T2DM and MASLD (defined by MRI-PDFF ≥10%) will be randomized in a 1:1 ratio to receive either once-daily iGlarLixi or iGlar, both in combination with metformin, for 12 weeks. The primary outcome is the change in liver fat content assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF) from baseline to week 12. Key secondary outcomes include changes in liver enzymes, liver inflammation, fibrosis indices (assessed by transient elastography and FIB-4 index), body composition (weight, BMI, waist circumference, waist-to-hip ratio, and visceral fat area), glycemic control (HbA1c, fasting and postprandial glucose), insulin function, lipid profiles, and uric acid. Safety assessments will include monitoring of hypoglycemic events, gastrointestinal adverse events, and other adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Type 2 Diabetes Mellitus.
- •Diagnosis of MASLD with liver fat content defined by MRI-PDFF ≥ 10%.
- •HbA1c ≥ 9.0% at screening.
- •Body Mass Index (BMI) between 25.0 and 35.0 kg/m², with stable weight (change < 10% in the past 3 months).
- •Stable antidiabetic regimen for at least 3 months prior to screening.
排除标准
- •1. History of excessive alcohol consumption (≥210 g/week for men, ≥140 g/week for women).
- •2. Other known causes of chronic liver disease (e.g., viral hepatitis, autoimmune hepatitis, Wilson's disease, hemochromatosis).
- •3. Use of medications known to affect liver fat content (e.g., thiazolidinediones, SGLT2 inhibitors, GLP-1 receptor agonists, systemic corticosteroids) within 3 months prior to screening.
- •4. Presence of acute infections or diabetic acute complications (e.g., ketoacidosis, hyperosmolar state) within 2 weeks prior to screening.
- •5. History of pancreatitis or elevated amylase/lipase > 3 times the upper limit of normal (ULN).
- •6. Significant liver impairment (ALT or AST > 3 × ULN).
- •Moderate to severe renal impairment (eGFR < 60 mL/min/1.73m²).
- •Congestive heart failure (NYHA class III-IV).
- •Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN-2).
- •10. Severe gastrointestinal disease.
- •Contraindications to MRI examination.
- •Pregnancy or lactation.
- •Participation in another investigational drug study within 6 months prior to enrollment.
- •14. Known hypersensitivity to the study drugs or their excipients.
研究组 & 干预措施
iGlar group
Participants receive iGlar once daily at a fixed time for 12 weeks.
干预措施: IGlar U100 (Drug)
iGlarLixi group
Participants receive iGlarLixi once daily before breakfast for 12 weeks.
干预措施: iGlarLixi (Drug)
结局指标
主要结局
Absolute change from baseline to Week 12 in hepatic fat fraction
时间窗: Baseline, Week 12
The absolute change of liver fat content were measured by MRI-PDFF
Changes of liver fat content
时间窗: Baseline, 12 weeks
The changes of liver fat content were measured by MRI-PDFF
次要结局
- Percent change from baseline to Week 12 in hepatic fat fraction(Baseline, Week 12)
- Percentage of participants with at least 30% relative fat reduction at Week 12(week 12)
- Changes of visceral fat area(Baseline, Week 12)
- Changes of percent body fat(Baseline, Week 12)
- Changes of skeletal muscle mass index(Baseline, Week 12)
- Changes of uric acid(Baseline, Week 12)
- Changes of urine albumin to creatinine ratio(Baseline, Week 12)
- Changes of liver transaminase(Baseline, 12 weeks)
- Changes of liver inflammation index(Baseline, 12 weeks)
- Changes of FIB-4 index(Baseline, 12 weeks)
- Changes of body weight(Baseline, 12 weeks)
- Changes of body fat(Baseline, 12 weeks)
- Changes of muscle mass(Baseline, 12 weeks)
- Changes of HbA1c(Baseline, 12 weeks)
- Changes of plasma glucose(Baseline, 12 weeks)
- Changes of C-peptide(Baseline, 12 weeks)
- Changes of lipid metabolism indexes(Baseline, 12 weeks)
- Changes of liver stiffness measurement(Baseline, 12 weeks)
研究者
Yan Bi
Chief Physician
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School