CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 5 enrolled
Drug / intervention
Ghrelin Group 1 +1 moredrug
Likely dose
Ghrelin Group 1 2 mcg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01605435
NCT01605435Phase 2Completed

Ghrelin In Frail Elderly Subcutaneous Dose Finding Study

University of Pennsylvania·interventional·Posted May 24, 2012·Updated Dec 12, 2019

In Brief

A Phase 2 clinical trial evaluating Ghrelin Group 1 and Ghrelin Group 2 for The Frailty Syndrome. Completed, enrolled 5 participants across 1 site.

Detailed Summary

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. The purpose of this study is to determine the optimal subcutaneous ghrelin dose as a potential intervention for frail elderly individuals. We will examine food intake and metabolic parameters after placebo and ghrelin administration at three escalating subcutaneously administered doses.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 24, 2012
Enrollment StartMay 1, 2012
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 14.1 years ago

Interventions

Ghrelin Group 1drug

The first two participants received placebo at baseline visit, 2 mcg/kg as a single subcutaneous dose at Visit 2, 5 mcg/kg as a single subcutaneous dose at Visit 3, and 10 mcg/Kg as a single subcutaneous dose at visit 4. There was 3-10 days between visits.

Ghrelin Group 2drug

The next three participants received placebo at baseline visit, 5 mcg/kg as a single subcutaneous dose at Visit 2, 7.5 mcg/kg as a single subcutaneous dose at Visit 3, and 10 mcg/Kg as a single subcutaneous dose at visit 4.