Researching an Effect of GLP-1 Agonist on Liver STeatosis (REALIST)

Who can take part

Inclusion Criteria: * Age \> 18 years, \< 75 years * Patients with moderately controlled type 2 diabetes under oral antidiabetic drugs (OADs) (i.e. biguanides, sulfonylureas, glinides, alpha-glucosidase inhibitors) at a stable dose since at least 3 months. Standard basal insulin treatments for at least 6 months before inclusion are allowed in addition to predefined authorized OADs. * 7.0%≤HbA1c≤ 9.0% confirmed in two assays over the last six months * 25 \<BMI \<40 kg/m2 * Patients carriers of confirmed stable non-alcoholic steatohepatitis diagnosed by liver biopsy dating less than six months, with a NAS score ≥ 4 with at least 1 point in each of the categories (steatosis, ballooning and lobular inflammation) and with a fibrosis score greater than stage 1 fibrosis but less than stage 4 fibrosis * Stable weight during the six months prior to inclusion, i.e. the change in weight must not exceed 5% in the last six months since the last liver puncture biopsy (LPB). * Person volunteered to participate in the study, informed about study organization and having signed the consent form * Person affiliated to or beneficiary of a social security plan * Person undergone the medical examination adapted to research * At randomization: The diagnosis and the stage of non-alcoholic steatohepatitis must be confirmed after centralized reading of the hepatic histology of the liver puncture biopsy (LPB) performed within six months prior to inclusion, by a pathologist designated for the study. Exclusion Criteria: * Patients who received a treatment with a GLP-1 agonist, SGLT2 inhibitors, Thiazolidinediones (TZDs), hepatoprotective drugs such as silymarine (Legalon®) or Ursodeoxycholic acid (Cholurso®, Delursan®, Ursolvan®), vitamin E or Betaine during the six months prior to inclusion (3 months before the reference biopsy). Any treatment with DPP-4 inhibitors should be stopped on inclusion. * Patients receiving rapid or short-acting mealtime insulin or premixed insulin in the last 6 months before screening visit * Type 1 Diabetes * Patients with idiopathic hemochromatosis * Patients carriers of hepatitis B or C * Terminal renal impairment (calculated clearance \< 15 ml/min according to the CKD-EPI formula) * Class III or IV congestive heart failure according to the NYHA classification * Chronic alcoholism. The investigator while interviewing the patient at the baseline visit assesses alcohol consumption. This consumption must be limited to 30g/day of alcohol for men and 20g/day of alcohol for women * Hepatic fibrosis with a Kleiner score ≥ F3 (for a score = F3, patients with a platelet count \> 120,000 and an albumin concentration \> 35 g/l can be included) * Patients with gastrointestinal bleeding * History of acute or chronic pancreatitis * Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC), or personal history of non-familial medullary thyroid carcinoma * Patients who had bariatric surgery * Patients who received drug treatment for obesity, notably Orlistat, during the last 6 months * Patients with eating disorders (anorexia nervosa, bulimia nervosa, binge-eating disorder) which may compromise the achievement of dietary reinforcement goals * Patients with a known allergy or hypersensitivity to the study product or one of its excipients * Any other condition deemed incompatible with the proper conduct of the study as determined by the investigator * Patient having participated in another biomedical research with the taking of an experimental drug within 3 months prior to the screening visit or subject under an exclusion period for other biomedical research. * Woman of childbearing age without effective contraception * Person referred in articles L.1121-5, L.1121-7 and L.1121-8 of the Public Health Code: * Pregnant, parturient or breastfeeding woman * Minor person (non-emancipated) * Adult person under legal protection (any form of public guardianship) * Adult person incapable of giving consent * Person deprived of liberty for judicial or administrative decision, Person under psychiatric care according to articles L. 3212-1 and L. 3213-1.

Registry changes

No changes recorded since the trial was added.