Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Enyo Pharma
This is a phase 2, open-label, two-dose, randomized, parallel arms, single center study where subjects are participating for up to 32 weeks:
* Screening: 4 weeks
* Treatment: 16 weeks
* Follow-up: 12 weeks
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Signed and dated informed consent obtained before any trial-related activities
Male or female subject.
Age between 18 and 75 years, both inclusive.
Overweight or obesity (body mass index BMI ≥ 25.0 kg/m2 and ≤ 45.0 kg/m2) with or without type 2 diabetes mellitus (T2DM with an HbA1c ≤ 9.5%).
eGFR ≥ 30 and \< 90 (mL/min/1.73 m²).
Presumed mild to higher liver fibrosis as shown by a FIBROTEST score ≥ 0.28 and/or FIB-4 score ≥ 1.3.
You may not be if
Known or suspected hypersensitivity to IMP or any of the excipients or to any component of the IMP formulation.
Previous participation in this trial. Participation is defined as randomised.
Receipt of any medicinal product in clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before randomisation in this trial.
History of multiple and/or severe allergies to drugs including contrast media or foods or a history of severe anaphylactic reaction.
Known non-MASH liver disease.
History or presence of cirrhosis (evidenced on imaging or by histology, or liver decompensation, including ascites, hepatic encephalopathy, or presence of esophageal varices).
Total body weight loss of \>5% within 6 months prior to screening.
If female, pregnancy or breast-feeding.
Women of childbearing potential who are not using a highly effective contraceptive method and whose male partner is not using a highly effective contraceptive method for the entire study duration and for at least 6 weeks after last dosing
