NCT05670951

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
360

participants targeted

Target at P50-P75 for phase_3

Timeline
36mo left

Started Feb 2025

Typical duration for phase_3

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Feb 2025May 2029

First Submitted

Initial submission to the registry

January 2, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2023

Completed
2.2 years until next milestone

Study Start

First participant enrolled

February 27, 2025

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

2.7 years

First QC Date

January 2, 2023

Last Update Submit

January 22, 2026

Conditions

Intestinal Malabsorption

Outcome Measures

Primary Outcomes (1)

  • Numbers of days to achieve full enteral feeding

    28 days or discharge from hospital

Study Arms (2)

ELGN-2112

ACTIVE COMPARATOR
Drug: ELGN-2112

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ELGN-2112DRUG

Human insulin \[rDNA\]

ELGN-2112
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laniado Hospital

Netanya, 4244916, Israel

RECRUITING

MeSH Terms

Conditions

Malabsorption Syndromes

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2023

First Posted

January 4, 2023

Study Start

February 27, 2025

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

May 1, 2029

Last Updated

January 23, 2026

Record last verified: 2026-01

Locations

IL(1)