NCT05904626

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
13mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress33%
Oct 2025Jun 2027

First Submitted

Initial submission to the registry

March 30, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
2.4 years until next milestone

Study Start

First participant enrolled

October 28, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

1.6 years

First QC Date

March 30, 2023

Last Update Submit

April 6, 2026

Conditions

Intestinal Malabsorption

Outcome Measures

Primary Outcomes (2)

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

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

    Five days from birth until 42 days

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

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

    Five days from birth until 42 days

Study Arms (2)

ELGN-2112 Human insulin [rDNA]

ACTIVE COMPARATOR
Drug: ELGN-2112

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ELGN-2112DRUG

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.

ELGN-2112 Human insulin [rDNA]
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age1 Day - 5 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laniado Hospital

Netanya, Israel

RECRUITING

MeSH Terms

Conditions

Malabsorption Syndromes

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Miki Olshansky

    Elgan Pharma Ltd.

    STUDY DIRECTOR

Central Study Contacts

Miki Olshansky

CONTACT

972-4-6098626CA@elganpharma.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2023

First Posted

June 15, 2023

Study Start

October 28, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

April 9, 2026

Record last verified: 2026-04

Locations

IL(1)