Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05670951

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

The study will evaluate the effect of ELGN-2112 on intestinal malabsorption in preterm infants.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Intestinal Malabsorption Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

1 day–5 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Laniado Hospital

Netanya, 4244916, Israel

Location status: Recruiting

Location contact

Arya Simonds, MD

PRINCIPAL_INVESTIGATOR

Tilly Bernat

CONTACT

[email protected]

972-8609118

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female pre-term infant 26 and up to 32 weeks gestation. Gestational age matching (±2 weeks) between maternal dates and/or early antenatal ultrasound
  • Birth weight ≥ 500g
  • Singleton or twin birth

Exclusion criteria

-

Treatment and study plan

ELGN-2112

Drug

Human insulin [rDNA]

Placebo

Drug

Placebo

Primary outcomes

  1. Numbers of days to achieve full enteral feeding

    Time frame: 28 days or discharge from hospital

Sponsors and collaborators

Lead sponsor

Elgan Pharma Ltd.

Industry

Registry information

Official study title

A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Jan 4, 2023
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.