Lipigon Pharmaceuticals AB announces that the Swedish Medical Products Agency and the Swedish Ethical Review Authority, via the European application system CTIS, have approved Lipigon's application to conduct a phase II study. With this approval, Lipigon can now start the phase II study with Lipisense® in patients with severe hypertriglyceridemia. The study will be conducted entirely in Sweden at three to four different trial clinics and will include up to 26 patients with severely elevated blood fats of the triglyceride type and underlying type 2 diabetes.

The patients are treated for one month with four doses of Lipisense® and then followed for six months where safety parameters, blood lipids and other important metabolic factors are studied. Lipigon will begin screening patients for inclusion in the study as soon as possible. The goal is to administrate the last dosage in the second half of 2024.

The phase I study showed that Lipisense® can effectively lower the levels of the target protein ANGPTL4 in plasma, which is believed to significantly contribute to the etiology of metabolic disorders. Focusing on patients with high ANGPTL4 levels, Lipisense® is not only a potential blood lipid lowering agent but may also have a positive effect on blood glucose homeostasis. With the potential to affect several metabolic parameters, Lipisense® is an attractive candidate in a competitive pharmaceutical segment.

Lipigon's phase II study aims to evaluate the safety of Lipisense® in patients, while providing the opportunity to measure important indicators of the drug candidate's effect. The study has been designed in collaboration with leading clinical experts, which strengthens the positioning of Lipisense®.