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

Elgan Pharma

Status and phase: Enrolling; Phase 3

Conditions: Intestinal Malabsorption

Treatments: Drug: ELGN-2112; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05670951

FIT-PIV

Details and patient eligibility

About

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

Enrollment: 360 estimated patients

Sex: All

Ages: 1 to 5 days old

Volunteers: No Healthy Volunteers

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

-

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

360 participants in 2 patient groups, including a placebo group

ELGN-2112

Active Comparator group

Treatment:

Drug: ELGN-2112

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo