Ongoing Clinical Trials for Malabsorption
There are currently 2 ongoing clinical trials investigating treatments for malabsorption, specifically focusing on preterm infants with intestinal malabsorption. These studies are evaluating the safety and effectiveness of ELGN-2112, an oral insulin solution, across multiple European countries including Austria, France, Italy, Netherlands, Spain, and Sweden.
Clinical trial locations
- Austria
- France
- Italy
- Netherlands
- Spain
- Sweden
Study on the Effects of ELGN-2112 (Human Insulin) for Treating Intestinal Malabsorption in Preterm Infants
This study is evaluating whether ELGN-2112, an oral insulin solution, can help preterm infants with intestinal malabsorption reach full feeding more quickly. Intestinal malabsorption means the intestines cannot absorb nutrients properly, which is particularly problematic for babies born early.
Who can participate:
- Preterm infants born between 26 and 32 weeks of pregnancy
- Birth weight of at least 500 grams
- Age up to 5 days old
- Single births or twins
- Infants who can breathe with limited oxygen support
- Stable heart and blood pressure without needing central line support
- Ability to tolerate feeding through a tube into the stomach
- Parents or legal guardians must provide informed consent
Who cannot participate:
Patients who already have intestinal malabsorption cannot join this study.
What the trial involves:
The study compares ELGN-2112 to a placebo to see how quickly infants can achieve full enteral feeding, defined as consuming at least 150 ml/kg/day for three consecutive days. Researchers will monitor how long it takes for infants to stop needing nutrition through a vein, whether they develop necrotizing enterocolitis (a serious intestinal condition), and their overall time to hospital discharge.
Investigational drug:
ELGN-2112 is an oral solution containing human insulin. While insulin is commonly used to regulate blood sugar, this study is testing whether it can help improve nutrient absorption in the intestines of preterm infants. The medication is given as a powder that is mixed into a liquid and administered through a feeding tube.
Study on the Safety of ELGN-2112 for Preterm Infants with Intestinal Malabsorption
This companion trial focuses specifically on evaluating the safety of ELGN-2112 in the most vulnerable preterm infants: those born before 26 weeks of pregnancy and those with intrauterine growth restriction, meaning they were smaller than expected for their gestational age.
Who can participate:
- Preterm infants born before 26 weeks of pregnancy, or
- Infants with intrauterine growth restriction born between 26 and 32 weeks
- Birth weight of at least 450 grams
- Age up to 5 days old
- Single births or twins
- Stable enough to complete the trial in the doctor’s opinion
- Limited oxygen support requirements
- Stable heart and blood pressure without central line support
- Ability to tolerate feeding through a tube
- For participants in France, must have health insurance
- Parents or legal guardians must provide informed consent
Who cannot participate:
Patients with intestinal malabsorption cannot participate in this safety study.
What the trial involves:
This safety-focused study compares ELGN-2112 to a placebo while closely monitoring vulnerable infant populations. Researchers will track the time to achieve full tube feeding, days until stopping intravenous nutrition, occurrence of intestinal problems or infections, hospital discharge timing, and growth and development. The study is expected to continue until 2033, with recruitment beginning in 2025.
Investigational drug:
ELGN-2112 is the same oral insulin solution being tested in the first study. This trial specifically examines whether the medication is safe for the most fragile preterm infants. The medication works at the molecular level to enhance nutrient absorption in the intestines and is classified as a gastrointestinal agent.
Summary
Both ongoing trials are investigating ELGN-2112, an innovative oral insulin treatment for intestinal malabsorption in preterm infants. The first study focuses on effectiveness in infants born between 26 and 32 weeks of pregnancy, while the second emphasizes safety in even more premature infants or those with growth restrictions.
These trials are concentrated in European countries, with five nations participating in both studies: Austria, France, Italy, Netherlands, and Spain. Sweden is an additional location for the effectiveness study. This represents a coordinated international effort to address a serious challenge facing the most vulnerable newborns.
The use of oral insulin to treat intestinal malabsorption represents a novel approach. While insulin is traditionally associated with blood sugar regulation, these studies explore whether it can help preterm infants’ intestines absorb nutrients more effectively. Both trials aim to help infants reach full feeding through the digestive system more quickly, potentially reducing their need for intravenous nutrition and shortening hospital stays.