NCT03520062: LIRAP

The Effect of Liraglutide on Pancreatic Hormones and Its Size

Completed NA Last updated 24 March 2020

What this trial tests

NA trial testing Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml in Obesity in 14 participants. Completed in 1 January 2020.

Timeline

15 August 2017

Primary endpoint
30 April 2019

1 January 2020

Quick facts

Lead sponsor	Nicolai Jacob Wewer Albrechtsen
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	14
Start date	15 August 2017
Primary completion	30 April 2019
Estimated completion	1 January 2020
Sites	1 location across Denmark

Drugs / interventions tested

• Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml — full drug profile →

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

Nicolai Jacob Wewer Albrechtsen

Who can join

Adults 18 to 65, male only, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Glucagon-like peptide-1 (GLP-1) is a gastrointestinal hormone used to treat type 2 diabetes and severe overweight (Liraglutide).The two pancreas enzymes: amylase and lipase are slightly elevated in GLP-1 treated compared with placebo-treated individuals. Increased levels of these two enzymes (amylase and lipase) are associated with acute inflammation of the pancreas (acute pancreatitis). In humans treated with GLP-1 (receptor agonist) there have not been found an increased risk of acute pancreatitis.

Animal and cell studies have shown that the increased levels of amylase and lipase in the blood are not due to an inflammatory state but adaptive changes (volume increase) of the pancreas.

The investigators (professor Jens Juul Holst, professor Sten Madsbad) want to investigate whether the increased levels of amylase and lipase in the blood of individuals treated with the GLP-1 analogue Saxenda are due adaptive changes of the pancreas. This will be achieved by measuring amylase and lipase before, during and after treatment with a GLP-1 receptor agonist, and at the same time use advanced scanning equipment (PET-MR) from the Clinical Physiological and Nuclear Medical Department at Rigshospitalet, which can determine any volumetric changes in the pancreas with high reproducibility.

The scan will be centered on the pancreas, other organs are not evaluated why the study is not designed to detect any malignant findings in the pancreas or other organs.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 56^th EASD Annual Meeting of the European Association for the Study of Diabetes : 21-25 September 2020.
   · 2020 · cited 9× · PMID 32840677 · DOI 10.1007/s00125-020-05221-5
2. Neprilysin activity is increased in metabolic dysfunction-associated steatotic liver disease and normalizes after bariatric surgery or GLP-1 therapy.
   Kjeldsen SAS, Gluud LL, Werge MP, Pedersen JS, et al · · 2023 · cited 4× · PMID 37953952 · DOI 10.1016/j.isci.2023.108190