Safety of ELGN-2112 in extremely preterm and growth-restricted newborns
A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Basket Study to Assess the Safety of ELGN-2112 in Preterm Infants Born Under 26 Weeks GA and IUGR Infants Born 26-32 Weeks GA
This will test whether ELGN-2112 is safe compared with placebo in infants born before 26 weeks and in growth-restricted infants born at 26 to 32 weeks.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 1 Day to 5 Days |
| Sex | All |
| Sponsor | Elgan Pharma Ltd. Industry-sponsored |
| Locations | 1 site (Netanya) |
| Trial ID | NCT05904626 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional trial compares ELGN-2112 to placebo in two high-risk neonatal groups: infants born under 26 weeks gestational age and intrauterine growth restricted (IUGR) infants born between 26+0 and 31+6 weeks. Eligible infants must weigh at least 450 g at birth and may be singletons or twins. Enrolled newborns will receive either ELGN-2112 or placebo and will be monitored closely for safety and tolerability during their hospital stay and through planned follow-up assessments. Safety data will be compared between the treatment and placebo groups to inform further development.
Who should consider this trial
Good fit: Ideal candidates are newborns born before 26 weeks gestation or IUGR infants born between 26+0 and 31+6 weeks with a birth weight of at least 450 g, including singletons and twins.
Not a fit: Infants born after 32 weeks gestation, those without growth restriction or intestinal malabsorption issues, or those not born at or transferred to the study site are unlikely to benefit from this trial.
Why it matters
Potential benefit: If ELGN-2112 is safe, it could become a new option to reduce intestinal malabsorption complications in extremely preterm and growth-restricted infants.
How similar studies have performed: There are limited published data on ELGN-2112 specifically, and while other early-phase neonatal intestinal therapies have advanced to later trials, results across similar approaches have been mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Netanya
- Laniado Hospital — Netanya, Israel (Recruiting)
Study contacts
- Study coordinator: Miki Olshansky
- Email: CA@elganpharma.com
- Phone: 972-4-6098626
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.