ClinicalTrials.gg
RecruitingNCT05670951Updated Jan 23, 2026

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

A Phase 3 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 2026-01-23.

Sponsored by Elgan Pharma Ltd. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 8 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
360
Allocation
Randomized
Ages
1 Day to 5 Days
Sex
All
01

Study summary

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

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 360 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 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

Exclusion Criteria:

-

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
360 participants (estimated)

Study arms

  • Active comparator
    ELGN-2112

    Drug: ELGN-2112

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugELGN-2112

    Human insulin \[rDNA\]

  • DrugPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. Numbers of days to achieve full enteral feeding

    Time frame: 28 days or discharge from hospital

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05670951
Lead sponsor
Elgan Pharma Ltd.
Responsible party
Sponsor
First posted
Jan 4, 2023
Start date
Feb 27, 2025
Primary completion
Nov 2027 (estimated)
Completion
May 2029 (estimated)
Last update
Jan 23, 2026

Oversight

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

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion