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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2027-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Intestinal Malabsorption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ELGN-2112 Human insulin [rDNA]

Group Type ACTIVE_COMPARATOR

ELGN-2112

Intervention Type 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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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ELGN-2112

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.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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