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RecruitingNCT05904626Updated Apr 9, 2026

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

A Phase 2 interventional study of ELGN-2112 and Placebo in Intestinal Malabsorption, sponsored by Elgan Pharma Ltd.. Recruiting at 1 site in Israel. Open to participants aged 1 Day to 5 Days. Per ClinicalTrials.gov, last updated 2026-04-09.

Sponsored by Elgan Pharma Ltd. · Phase 2, Interventional, and Other

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year later.
Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
1 Day to 5 Days
Sex
All
01

Study 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.

02

Conditions studied

  • Intestinal Malabsorption
03

In context

Malabsorption Syndromes

54 studies on the registry are indexed under Malabsorption Syndromes; 12 are open to participants now.

This study's planned enrollment of 60 is above the median of 38 across 44 interventional studies indexed under Malabsorption Syndromes.

Browse Malabsorption Syndromes studies →

Lead sponsor

Elgan Pharma Ltd. is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 5 Days
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

N/A

05

Study design

Phase
Phase 2
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    ELGN-2112 Human insulin [rDNA]

    Drug: ELGN-2112

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugELGN-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.

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Five days from birth until 42 days

  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.

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

    Time frame: Five days from birth until 42 days

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2025 (actual). Primary completion is estimated for Jun 2027, 20 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 30, 2023
First posted
Jun 15, 2023
StartActual
Oct 28, 2025
Primary completionEst.
Jun 2027
CompletionEst.
Jun 2027
Last update
Apr 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05904626
Lead sponsor
Elgan Pharma Ltd.
Responsible party
Sponsor
First posted
Jun 15, 2023
Start date
Oct 28, 2025
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Apr 9, 2026

Study contacts

Miki Olshansky
Contact
CA@elganpharma.com
972-4-6098626
Miki Olshansky
study director · Elgan Pharma Ltd.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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