Effects of GH and Lirglutide on AgRP

What Was Tested

The trial (phase 4) is built around Liraglutide.

This is a randomized, placebo-controlled, cross-over study with 4 arms.

Arms will consist of 21-day treatment periods and be separated by 8-week washout periods.

It had four arms (groups): Growth hormone (active comparator), Liraglutide (active comparator), Growth hormone and liraglutide (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Rationale: GH and IGF-1 are vital to growth and metabolism across the human lifespan.

GH may signal nutrient status via AgRP neurons.

Therefore, this project directly tests that GH administration stimulates AgRP in humans.

To further investigate the GH-AgRP axis, this project also tests the effect of the GLP-1R agonist liraglutide on plasma AgRP levels and explores the potential link of GH-stimulated changes in AgRP to GH-induced insulin resistance.

Who Took Part

40 planned participants were the target.

It was open to people of any sex aged from 18 years up to 45 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: No medical conditions except being overweight/obese in half of subjects. No prescription medication or other drug use. Premenopausal women: use of nonhormonal method of contraception. 24 patients with isolated GH deficiency:12 males, 12 females. Ages 18-45 years.

The full record lists 12 inclusion and 8 exclusion criteria; among the exclusions: history of malignancy, diabetes, thyroid cancer or pancreatitis; use of glucocorticoids, hormonal supplements or medications that could affect gh or igf-1 or for weight loss within 6 months of enrollment; DM requiring medication.

How the Study Was Run

It was run as a randomized, sequential and single-blind study.

The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

In this single-blind Liraglutide study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2023-05-01 with completion listed for 2028-04-30.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: AgRP change in GH vs. placebo arms (time frame: Baseline to weeks 1, 2, 3 of each study arm). AgRP change in GH vs. GH + liraglutide arms (time frame: Baseline to weeks 1, 2, 3 of each study arm).

It also tracked 2 secondary outcomes, for example AgRP change in GH arm and AgRP change in liraglutide vs. placebo arms.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 40 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, all human trials.