NCT04897984

LEAP2 Kinetics in Healthy Individuals

The Kinetics of LEAP2 in Man

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: University Hospital, Gentofte, Copenhagen · Academic / Other
• Sex: Male
• Age: 18 Years – 25 Years
• Healthy volunteers: Accepted

Summary

The study aims to investigate the kinetics of the naturally occurring peptide liver-enriched antimicrobial peptide 2 (LEAP-2) in healthy volunteers. The overall objective is to investigate the physiological importance of LEAP-2 in healthy subjects.

Detailed description

In a recent study, the molecular phenotype of enteroendocrine cells in the small intestine before and after Roux-en-Y Gastric Bypass (RYGB) surgery in obese individuals was examined. Enteroendocrine cells were identified and isolated from intestinal biopsies and analysed for differentially expressed genes by Illumina High Throughput RNA-sequencing. It was discovered that the gene encoding liver-enriched antimicrobial peptide 2 (LEAP2), a naturally occurring peptide in humans, was significantly upregulated compared to baseline expression. Interestingly, LEAP2 was recently shown to antagonize ghrelin function in response to feeding in mice. Moreover, the mature murine LEAP2 peptide is identical in mice and humans. Thus, LEAP2 has been identified as an endogenous peptide that may be able to alter feeding behaviour and maintenance of glucose levels during calorie restriction. This study aims to investigate the kinetics of exogenous LEAP2 in healthy subjects.

Conditions

• Obesity

Interventions

Type	Name	Description
BIOLOGICAL	Liver-enriched antimicrobial peptide 2	IV infusion of LEAP2, 2 hours

Timeline

• Start date: 2021-05-24
• Primary completion: 2021-06-25
• Completion: 2021-06-25
• First posted: 2021-05-24
• Last updated: 2021-09-28

Locations

1 site across 1 country: Denmark