Product X Profile

Indication

Approved for patients with Steatosis in patients with NAFLD confirmed by elevated enzyme levels/ ultrasound scan

Efficacy

In Phase III trials conducted against Liraglutide 3 mg as active comparator, Product X caused a statistically significant 10% decrease in plasma aminotransferase levels and 20% reduction in hepatic steatosis (assessed by CT scan, measured as percentage of hepatocytes with fat deposition) compared to the active comparator arm

Safety

Patients in study group did not have any statistically significant differences compared to the control group (liraglutide) in the incidence of adverse effects. Incidence of nausea in the study group was less than 1% (nausea is common with liraglutide)

Tolerability

Statistically similar percentages of patients in both groups dropped off their treatment regimen due to tolerability issues.

Contra indications

Not contra indicated in patients with hepatic insufficiency or renal insufficiency (liraglutide is contraindicated in both patient groups)

Route of administration

Oral (SC injection once daily with Liraglutide)

Frequency of dosing

Once daily (3 times daily with Orlistat)

Doses available

Multiple dosage strengths with dosage based on BMI

Key benefits

Once daily oral tablet with 10% higher efficacy in terms of reducing plasma aminotransferase levels and 20% higher efficacy in reversing Steatosis, with similar safety profile as Saxenda, but no nausea and not contra indicated in patients with renal or hepatic insufficiency