Ghrelin Repeated Dose Study

What Was Tested

In this phase 2 trial, researchers set out to test Ghrelin.

Frailty is a geriatric syndrome leading to physical deterioration including muscle wasting (sarcopenia) and unintentional weight loss.

There are currently no approved therapies for frailty.

Ghrelin is a hormone produced by the stomach that stimulates appetite centers in the brain.

It had 1 arm (groups): one (other).

The registry classes the interventions as drug.

More on the Plan

There will be a screening visit plus three additional study visits at the CTRC on Days 1, 2, and 7.

Participants will receive an injection of ghrelin subcutaneously once daily on Days 1 and 7 and will self-administer the subcutaneous injection before breakfast on Days 2-6 at home.

A food record will be kept from Day -3 to Day 6.

Who Took Part

Enrollment: 5 actual participants took part.

It was open to people of any sex aged from 70 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Individuals with three, four or five frailty criteria using the Fried frailty criteria.

The full record lists 1 inclusion and 15 exclusion criteria; among the exclusions: hospitalization for stroke, myocardial infarction, coronary artery bypass graft surgery, vascular surgery in the past six months; new york heart association class iii or iv congestive heart failure; therapy for cancer in the past 12 months, except non-melanoma skin cancer.

How the Study Was Run

It was run as a single-group and open-label study.

Being open-label, the Ghrelin study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2013-02 with completion listed for 2013-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Safety (time frame: pre-treatment baseline through 30 days following the last administration of study treatment day 7).

What This Means in Plain Language

Put simply, this is a phase 2 trial of Ghrelin in 5 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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