LEAP2 Kinetics in Healthy Individuals

NCT04897984 | Completed Early Phase 1 DMC

• 1 other identifier: LEAP2 kinetics
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Plasma concentrations of LEAP2

  Plasma concentrations of LEAP2

  -30 to 270 minutes

Secondary Outcomes (1)

• VAS

  -30 to 270 minutes

Study Arms (1)

Liver-enriched antimicrobial peptide 2

EXPERIMENTAL

IV infusion of LEAP2, 2 hours

Biological: Liver-enriched antimicrobial peptide 2

Interventions

Liver-enriched antimicrobial peptide 2 BIOLOGICAL

IV infusion of LEAP2, 2 hours

Liver-enriched antimicrobial peptide 2

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Caucasian men
• Age between 18 and 25 years
• Body mass index between 20-35 kg/m2
• Informed consent

You may not qualify if:

• Anaemia (haemoglobin below normal range)
• Alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) \>2 times normal values) or history of hepatobiliary and/or gastrointestinal disorder(s)
• Nephropathy (serum creatinine above normal range and/or albuminuria)
• Allergy or intolerance to ingredients included in the standardised meals
• First-degree relatives with diabetes and/or glycated haemoglobin (HbA1c) \>48 mmol/mol
• Regular tobacco smoking or use of other nicotine-containing products
• Any ongoing medication that the investigator evaluates would interfere with trial participation.
• Any physical or psychological condition that the investigator evaluates would interfere with trial participation including any acute or chronic illnesses

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead

Study Sites (1)

Center for Clinical Metabolic Research

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Filip K Knop, MD, PhD

  Center for Clinical Metabolic Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, head of department

Model Details: The study is designed as a clinical study involving one experimental study day.

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 24, 2021
• Study Start: May 24, 2021
• Primary Completion: June 25, 2021
• Study Completion: June 25, 2021
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)