Effects of an Oral GH Secretagogue (MK-677) on Body Composition and Functional Ability of Older Adults

What Was Tested

The trial (phase 1, phase 2) is built around MK-677 (Ibutamoren).

The registry classes the interventions as drug.

More on the Plan

This is a two year, double-blind, placebo-controlled cross-over trial of once daily administration of MK-677, an oral GH secretagogue, to healthy older adults.

During the first year, subjects will be randomized to MK-677 or placebo treatment.

In each of three subgroups of subjects (men, women off and women on hormone replacement therapy), 16 subjects will receive MK-677 and 8 will receive placebo.

Who Took Part

The registry lists 72 planned participants were the target.

It was open to people of any sex aged from 60 years with no upper age limit.

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

Examples of who could join: Healthy men and women  60 years of age, with a body mass index of \< 35 kg/m2.

The full record lists 1 inclusion and 17 exclusion criteria; among the exclusions: medication known to affect gh secretion, other than estrogen replacement therapy; coronary artery disease,; congestive heart failure,.

How the Study Was Run

Design: randomized, crossover and double-blind.

Random assignment meant chance, not the researchers, decided who got MK-677 (Ibutamoren) and who got the comparison, which limits bias.

Each person switched between MK-677 (Ibutamoren) and the comparison at some point, usually with a gap in between.

As a double-blind MK-677 (Ibutamoren) study, the assignments were hidden from both participants and investigators until the end.

It started in 1998-07 with completion listed for 2004-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): At 12 months: 24-hour mean growth hormone concentrations. Insulin-like growth factor-I concentrations. Body weight and fat mass, specifically abdominal visceral fat.

It also tracked 13 secondary outcomes, for example at 12 months: Growth hormone secretory dynamics, Isokinetic muscle strength (knee and shoulder), Thigh muscle cross-sectional area, Function tests (timed walks, stair climb, chair rise), Quality of life assessments and Insulin sensitivity.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of MK-677 (Ibutamoren) in 72 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the MK-677 (Ibutamoren) compound page, all human trials.