Study of ELGN-2112 to Treat Intestinal Malabsorption in Preterm Infants Born Between 26 and 32 Weeks Gestation

What this Trial Is About

Researchers are evaluating the effects of ELGN-2112, a human insulin rDNA, on intestinal malabsorption in preterm infants. The study is designed as a multi-center, double-blind, randomized, placebo-controlled phase 3 trial to assess both the safety and efficacy of ELGN-2112 in this vulnerable population. The trial includes two groups one receiving ELGN-2112 and the other receiving a placebo. Participants are preterm infants born between 26 and 32 weeks gestation, with birth weight of at least 500 grams, including singletons and twins. The study uses a quadruple masking approach to ensure unbiased results. Participants will be monitored to measure the number of days it takes to achieve full enteral feeding, either within 28 days or by hospital discharge. The study involves regular assessments to track feeding progress and safety, with the total duration extending until the primary outcome is reached. The study is sponsored by Elgan Pharma Ltd. and is planned to run until May 2029.

Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants