NCT05804513

The Effect of Lixisenatide on the Effect of Pituitary Hormones

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: University of Tartu · Academic / Other
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The current study has two aims: 1. to test the hypothesis that a single dose of lixisenatide can be used as a growth hormone stimulation test; 2. to test if the growth hormone-stimulating effect is mediated by changes in blood glucose. The secondary objective of the study is to monitor the effect of lixisenatide on other pituitary hormones and physiological parameters (blood glucose, blood pressure, heart rate, nausea).

Detailed description

The randomized, blinded, placebo-controlled clinical trial is conducted on 5 healthy volunteers and 5 patients with type 1 diabetes. All study subjects receive once a placebo and once 10 micrograms of lixisenatide. The order of administration of study medication is decided on randomization. The placebo and lixisenatide are administered at least 2 days apart. Blood samples are taken 30 minutes and immediately before study medication administration and 30, 60, 90, 120, and 150 minutes after study medication administration,. The primary endpoint is the peak value of growth hormone measured during the 2,5 hours after study medication administration.

Conditions

• Healthy
• Type 1 Diabetes

Interventions

Type	Name	Description
DRUG	Placebo	s/c injection
DRUG	Lixisenatide 10 micrograms (50 micrograms/ml in 3 ml) Pen Injector	s/c injection

Timeline

• Start date: 2023-04-17
• Primary completion: 2023-10-31
• Completion: 2023-12-31
• First posted: 2023-04-07
• Last updated: 2023-06-12

Locations

1 site across 1 country: Estonia