Unacylated Ghrelin to Improve Functioning in PAD

What Was Tested

The trial (phase 2) is built around Ghrelin.

GIFT is a pilot, randomized, double-blinded clinical trial that will examine the effects of unacylated ghrelin on walking ability in people with peripheral artery disease (PAD) compared to placebo.

A total of 30 participants with PAD will be randomized to one of two groups: unacylated ghrelin injections or placebo injections .

It had two arms (groups): Unacylated ghrelin (active comparator) and Placebo (placebo comparator).

Participants randomized to placebo will self-administer an identical-appearing solution of bacteriostatic saline daily.

The registry classes the interventions as drug.

More on the Plan

Work from the McDermott research team and that of other investigators shows that patients with lower extremity peripheral artery disease (PAD) have greater functional impairment, faster functional decline, and higher rates of mobility loss compared to people without PAD.

In patients with PAD, ischemia results in calf muscle injury that includes myofiber loss and calf muscle mitochondrial dysfunction.

Ghrelin is a peptide and hormone that circulates in acylated and unacylated forms.

Who Took Part

The registry lists 25 actual participants took part.

It was open to people of any sex aged from 55 years with no upper age limit.

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

Examples of who could join: 55 years and older. Presence of peripheral artery disease defined as either:. An ankle-brachial index (ABI) of less than or equal to 0.90 at the baseline study visit. Vascular lab evidence of PAD or angiographic evidence of PAD with ischemic leg symptoms during the six-minute walk and/or treadmill exercise stress test.

The full record lists 4 inclusion and 21 exclusion criteria; among the exclusions: above- or below-knee amputation; critical limb ischemia; wheelchair-bound or requiring a cane or walker to ambulate.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Random assignment meant chance, not the researchers, decided who got Ghrelin and who got the comparison, which limits bias.

The Ghrelin group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Ghrelin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2020-07-08 with completion listed for 2025-01-23.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: 4-month Change in Six-minute Walk Distance (time frame: Baseline to 4 months).

It also tracked 2 secondary outcomes, for example 4-month Change in Maximal Treadmill Walking Time and 4-month Change in Calf Muscle Perfusion.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Ghrelin in 25 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.