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AgingPhase 1/2MOT089NCT00474279

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

A Phase 1/2 study testing Orally active growth hormone secretagogue (MK-677) in people with Aging, run by University of Virginia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether treatment of healthy older men and women with oral MK-677 for 12 months will enhance pulsatile GH release and increase mean GH and IGF-I concentrations into the range of young adults and will have favorable effects on body composition and functional ability on older… Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Aging
What is being tested?
Orally active growth hormone secretagogue (MK-677)
Type of treatment
Pill or oral medicine
How many people
72 participants
Where
1 siteUnited States
Study dates
Jul 1998to Jun 2004
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy men and women  60 years of age, with a body mass index of < 35 kg/m2.

Who cannot join

  • Medication known to affect GH secretion, other than estrogen replacement therapy
  • Coronary artery disease,
  • Congestive heart failure,
  • Peripheral vascular disease,
  • Diabetes mellitus (requiring insulin or an oral hypoglycemic agent),
  • Significant hypertension (BP >180 systolic or >100 diastolic at rest);
Show all 17Show fewer
  • Renal, hepatic, pulmonary disease;
  • Untreated hypothyroidism, untreated hyperthyroidism;
  • History of seizure disorder;
  • History of malignancy (other than some skin cancers), history of active chronic infections (e.g., HIV, tuberculosis).
  • Hematocrit < 40%, men, < 36%, women
  • History of daily tobacco use within past 3 months
  • Chronic alcohol abuse
  • Strenuous exercise for average of more than 60 min/day
  • Investigational drug within past 6 weeks
  • Psychiatric history, especially anorexia nervosa
  • Transmeridian travel within 2 weeks prior to or during study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Virginia

    Charlottesville, Virginia, 22908

Other trials in United States

About this study

The purpose of this study is to determine whether treatment of healthy older men and women with oral MK-677 for 12 months will enhance pulsatile GH release and increase mean GH and IGF-I concentrations into the range of young adults and will have favorable effects on body composition and functional ability on older adults.

Read the detailed description

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. After 1 year, the subjects who received placebo will be switched to MK-677 treatment; the subjects who received MK-677 for the first year will be randomized to either placebo or MK-677 for the second year of the study.The study will test changes in GH, IGF-I, body composition and function.

Conditions
Aging
Being tested
Orally active growth hormone secretagogue (MK-677)
Keywords
Growth hormone secretagogue, Body composition, Functional ability, Aging, Sarcopenia
Medical subject headings
Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Orally active growth hormone secretagogue (MK-677)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. At 12 months: 24-hour mean growth hormone concentrations

  2. Insulin-like growth factor-I concentrations

  3. Body weight and fat mass, specifically abdominal visceral fat

  4. Fat-free mass

  5. Safety determined by routine laboratory tests at 1 to 3 month intervals, yearly pap smears and mammograms

Secondary outcomes (13)

  1. at 12 months: Growth hormone secretory dynamics

  2. Isokinetic muscle strength (knee and shoulder)

  3. Thigh muscle cross-sectional area

  4. Function tests (timed walks, stair climb, chair rise)

  5. Quality of life assessments

  6. Insulin sensitivity

  7. Lipid profile

  8. Resting metabolic rate

  9. Aerobic exercise capacity

  10. Exploratory outcomes:

  11. effects of gender and HRT on primary outcomes

  12. effects of treatment in year 2: Year 2 outcomes include effects of continuation on MK-677, or crossover to placebo, placebo to MK-677

  13. bone mineral density at end of year 2.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2007 (estimated)
  2. Study startJul 1998
  3. Study completionJun 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Enrolment
72 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00474279
Sponsor's protocol ID
HIC #7444
Other IDs
NIH RO1 DK32632
Acronym
MOT089
Status last verified
May 2007
First submitted
15 May 2007
Last updated
16 May 2007
Results posted
No
Data monitoring committee
Yes

Publications

  • Chapman IM, Bach MA, Van Cauter E, Farmer M, Krupa D, Taylor AM, Schilling LM, Cole KY, Skiles EH, Pezzoli SS, Hartman ML, Veldhuis JD, Gormley GJ, Thorner MO. Stimulation of the growth hormone (GH)-insulin-like growth factor I axis by daily oral administration of a GH secretogogue (MK-677) in healthy elderly subjects. J Clin Endocrinol Metab. 1996 Dec;81(12):4249-57. doi: 10.1210/jcem.81.12.8954023.

    PubMed 8954023

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Orally active growth hormone secretagogue (MK-677) in people with Aging, run by University of Virginia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

At 12 months: 24-hour mean growth hormone concentrations. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00474279, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2007.

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