Intestinal MalabsorptionPhase 2NCT05904626
Assess the Safety of ELGN-2112 in Preterm Infants Born Under 26 Weeks GA and IUGR Infants Born 26-32 Weeks GA
A Phase 2 study testing ELGN-2112 in people with Intestinal Malabsorption, run by Elgan Pharma Ltd. at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 5 days
- Conditions the study is for
- Intestinal Malabsorption
- What is being tested?
- ELGN-2112
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 28 Oct 2025to Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 5 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Laniado Hospital
Netanya
Tilly Bernat, 972-8609118, tbernat@laniado.org.ll
About this study
Official title: 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
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.
- Conditions
- Intestinal Malabsorption
- Being tested
- ELGN-2112, Placebo
- Medical subject headings
- Malabsorption Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELGN-2112Drug
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.
PlaceboDrug
A placebo formulation consisting of the same inactive ingredients as ELGN-2112.
| Study group | Role | What they receive |
|---|---|---|
| ELGN-2112 Human insulin [rDNA] | Active comparator | Not described Receives: Drug: ELGN-2112 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA
Safety will be assessed by capturing of adverse events (AEs) during the treatment period.
Measured: Five days from birth until 42 days
Compare the safety of treatment with ELGN-2112 to placebo in preterm infants born IUGR infants<3rd percentile* born at 26-32 weeks GA.
Safety will be assessed by capturing of adverse events (AEs) during the treatment period.
Measured: Five days from birth until 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start28 Oct 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal MalabsorptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elgan Pharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Miki Olshansky, Study director, Elgan Pharma Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904626
- Sponsor's protocol ID
- FIT-05
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2023
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05904626
- Acronym / sponsor ID
- FIT-05
- Conditions
- Intestinal Malabsorption
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Elgan Pharma Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ELGN-2112 Human insulin [rDNA] | Active comparator | Drug: ELGN-2112 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 1 day to 5 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELGN-2112To 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. | Drug | ELGN-2112 Human insulin [rDNA] |
| PlaceboA placebo formulation consisting of the same inactive ingredients as ELGN-2112. | Drug | Placebo |
Primary outcome
Compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA
Time frame: 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.
Time frame: Five days from birth until 42 days
Safety will be assessed by capturing of adverse events (AEs) during the treatment period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Miki Olshansky study director
Elgan Pharma Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ELGN-2112 in people with Intestinal Malabsorption, run by Elgan Pharma Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miki Olshansky (972-4-6098626, CA@elganpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA (time frame: Five days from birth until 42 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.