Growth Hormone Secretagogue MK-0677's Effect on Lean Body Mass in Chronic Kidney Disease Stage 4/5 Subjects

What Was Tested

This registered phase 2 trial tested MK-677 (Ibutamoren).

This year-long investigator-initiated study is designed to determine effects of MK-0677, a GH secretagogue, in renal patients.

It is a double-blind, placebo-controlled trial employing the following procedures: Informed consent process, followed by evaluation and screening tests to confirm patients' eligibility.

Patients whose screening laboratory results for glycated hemoglobin level, thyroid function, or liver function exceed protocol eligibility criteria will not be randomized.

It had two arms (groups): MK-0677 (experimental) and Placebo (placebo comparator).

Inactive Pill used as a comparator.

The registry classes the interventions as drug.

Who Took Part

It was open to people of any sex aged from 18 years up to 85 years.

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

Examples of who could join: Male or female age 18 to 85.

The full record lists 2 inclusion and 31 exclusion criteria; among the exclusions: prior use of experimental drug, mk-0677; subject has been diagnosed with neuromuscular or neurological disease causing muscle weakness; body mass index greater than 35 kg/m2, or morbid obesity.

How the Study Was Run

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

Because people in this MK-677 (Ibutamoren) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on MK-677 (Ibutamoren), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2009-03 with completion listed for 2010-04.

It ran at 1 site in United States.

Its stated primary purpose is supportive care.

What Was Measured

Primary outcome: Lean body weight (time frame: 12 months).

It also tracked 5 secondary outcomes, for example Cytokine levels, Hormone levels, Nutritional status, Quality of life and Physical function.

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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