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NCT Number: NCT05904626

Assess the Safety of ELGN-2112 in Preterm Infants Born Under 26 Weeks GA and IUGR Infants Born 26-32 Weeks GA

To compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA and IUGR infants<3rd percentile* born at 26-32 weeks GA.

Recruiting

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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 2

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female preterm infant born less than 26 weeks GA or Intra-Uterine Growth Restricted infants born between 26+0 to 31+6 GA.
  • Birth weight ≥ 450g
  • Singleton or twin birth

Exclusion criteria

N/A

Treatment and study plan

ELGN-2112

Drug

To compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA and IUGR infants<3rd percentile* born at 26-32 weeks GA.

Placebo

Drug

A placebo formulation consisting of the same inactive ingredients as ELGN-2112.

Primary outcomes

  1. Compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA

    Time frame: Five days from birth until 42 days

    Safety will be assessed by capturing of adverse events (AEs) during the treatment period.

  2. Compare the safety of treatment with ELGN-2112 to placebo in preterm infants born IUGR infants<3rd percentile* born at 26-32 weeks GA.

    Time frame: Five days from birth until 42 days

    Safety will be assessed by capturing of adverse events (AEs) during the treatment period.

Study contacts

Contact information is provided by the study sponsor or research team.

Miki Olshansky

CONTACT

[email protected]

972-4-6098626

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 Basket Study to Assess the Safety of ELGN-2112 in Preterm Infants Born Under 26 Weeks GA and IUGR Infants Born 26-32 Weeks GA

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 15, 2023
Registry last updated
Apr 9, 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.

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