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

Phase 2

Not yet recruiting

• Conditions: Intestinal Malabsorption
• Interventions: Drug: ELGN-2112; Drug: Placebo

• Registration Number: NCT05904626
• Lead Sponsor: Elgan Pharma Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-30
• Study First Submitted QC: 2023-06-12
• Study First Posted: 2023-06-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-03
• Study Start: 2025-05
• Primary Completion: 2027-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

N/A

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ELGN-2112 Human insulin [rDNA]	ELGN-2112	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA	Five days from birth until 42 days	Safety will be assessed by capturing of adverse events (AEs) during the treatment period.
Compare the safety of treatment with ELGN-2112 to placebo in preterm infants born IUGR infants<3rd percentile* born at 26-32 weeks GA.	Five days from birth until 42 days	Safety will be assessed by capturing of adverse events (AEs) during the treatment period.