Effects of oral administration of ibutamoren mesylate, a nonpeptide growth hormone secretagogue, on the growth hormone-insulin-like growth factor I axis in growth hormone-deficient children.

Codner E, Cassorla F, Tiulpakov AN, Mericq MV, Avila A, Pescovitz OH, Svensson J, Cerchio K, Krupa D, Gertz BJ, Murphy G

Clinical pharmacology and therapeutics1 Jul 2001Cited by 28 (Europe PMC)

PMID11452249DOI10.1067/mcp.2001.116514PepBankPUB-11452249

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study12

12 results from studies that gave the peptide. 12 results from people.

01HumanNon-randomized trialEfficacy outcome
In GH-deficient children, ibutamoren increased median GH peak concentration from baseline by 3.8 microg/L.
In plain wordsIn GH-deficient children, ibutamoren increased peak growth hormone from baseline.
Peptide
MK-677 (ibutamoren)
Outcome
IncreaseGH peak concentration
Study
n: not reported in source
Comparator
Baseline
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.8 mg/kg per day · oral · 8 daysAs given in this study (human).
Measurements
GH peak concentration, median increase
3.8 microg/L
Median change from baseline in group III (0.8 mg/kg per day)
GH peak concentration increase, range
0 to 34.3 microg/L
Median change from baseline in group III (0.8 mg/kg per day)
P value for GH peak concentration change
0.001
Group III, ibutamoren mesylate 0.8 mg/kg for 8 days; day 15 versus baseline
Source sentences
Summary
After administration of ibutamoren mesylate 0.8 mg/kg for 8 days (group III), the median increases (on day 15) from baseline were as follows: 3.8 microg/L (range, 0 to 34.3) for serum GH peak concentration (P = .001)
2 context sentences(design, population, supporting numbers)
Summary · context
We evaluated the safety and tolerability and the GH-insulin-like growth factor (IGF) responses to two dosages of oral ibutamoren mesylate given to children with GH deficiency for 7 to 8 days.
Summary · context
Hormonal profiles were evaluated on day -1 (baseline) and day 15, and the results were expressed as the change from baseline within each group.
Report a problemFND-1145224901
02HumanNon-randomized trialEfficacy outcome
In GH-deficient children, ibutamoren increased median GH AUC from baseline by 4.3 microg x h/L.
In plain wordsIn GH-deficient children, ibutamoren increased growth hormone exposure from baseline.
Peptide
MK-677 (ibutamoren)
Outcome
IncreaseGH AUC
Study
n: not reported in source
Comparator
Baseline
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.8 mg/kg per day · oral · 8 daysAs given in this study (human).
Measurements
GH AUC(0-8), median increase
4.3 microg x h/L
Median change from baseline in group III (0.8 mg/kg per day)
GH AUC(0-8) increase, range
1.3 to 35.6 microg x h/L
Median change from baseline in group III (0.8 mg/kg per day)
P value for GH AUC(0-8) change
< 0.001
Group III, ibutamoren mesylate 0.8 mg/kg for 8 days; day 15 versus baseline
Source sentences
Summary
4.3 microg x h/L (range, 1.3 to 35.6) for the GH area under the concentration-time curve from time zero to 8 hours (AUC(0-8)) (P < .001)
2 context sentences(design, population, supporting numbers)
Summary · context
We evaluated the safety and tolerability and the GH-insulin-like growth factor (IGF) responses to two dosages of oral ibutamoren mesylate given to children with GH deficiency for 7 to 8 days.
Summary · context
Hormonal profiles were evaluated on day -1 (baseline) and day 15, and the results were expressed as the change from baseline within each group.
Report a problemFND-1145224902
03HumanNon-randomized trialEfficacy outcome
In GH-deficient children, ibutamoren increased median serum IGF-I from baseline by 12 microg/L.
In plain wordsIn GH-deficient children, ibutamoren increased IGF-I from baseline.
Peptide
MK-677 (ibutamoren)
Outcome
IncreaseIGF-I
Study
n: not reported in source
Comparator
Baseline
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.8 mg/kg per day · oral · 8 daysAs given in this study (human).
Measurements
Serum IGF-I, median increase
12 microg/L
Median change from baseline in group III (0.8 mg/kg per day)
Serum IGF-I increase, range
−4 to 116 microg/L
Median change from baseline in group III (0.8 mg/kg per day)
P value for serum IGF-I change
0.01
Group III, ibutamoren mesylate 0.8 mg/kg for 8 days; day 15 versus baseline
Source sentences
Summary
12 microg/L (range, -4 to 116) for serum IGF-I (P = .01)
2 context sentences(design, population, supporting numbers)
Summary · context
We evaluated the safety and tolerability and the GH-insulin-like growth factor (IGF) responses to two dosages of oral ibutamoren mesylate given to children with GH deficiency for 7 to 8 days.
Summary · context
Hormonal profiles were evaluated on day -1 (baseline) and day 15, and the results were expressed as the change from baseline within each group.
Report a problemFND-1145224903
04HumanNon-randomized trialEfficacy outcome
In GH-deficient children, ibutamoren increased median serum IGFBP-3 from baseline by 0.4 microg/L.
In plain wordsIn GH-deficient children, ibutamoren increased IGFBP-3 from baseline.
Peptide
MK-677 (ibutamoren)
Outcome
IncreaseIGFBP-3
Study
n: not reported in source
Comparator
Baseline
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.8 mg/kg per day · oral · 8 daysAs given in this study (human).
Measurements
Serum IGFBP-3, median increase
0.4 microg/L
Median change from baseline in group III (0.8 mg/kg per day)
Serum IGFBP-3 increase, range
−0.9 to 1.5 microg/L
Median change from baseline in group III (0.8 mg/kg per day)
P value for Serum IGFBP-3 change from baseline in group III (0.8 mg/kg per day), day 15 after 8 days
0.01 p value
Serum IGFBP-3 change from baseline in group III (0.8 mg/kg per day), day 15 after 8 days
Source sentences
Summary
and 0.4 microg/L (range, -0.9 to 1.5) for serum IGF-binding protein 3 (IGFBP-3) (P = .01).
2 context sentences(design, population, supporting numbers)
Summary · context
We evaluated the safety and tolerability and the GH-insulin-like growth factor (IGF) responses to two dosages of oral ibutamoren mesylate given to children with GH deficiency for 7 to 8 days.
Summary · context
Hormonal profiles were evaluated on day -1 (baseline) and day 15, and the results were expressed as the change from baseline within each group.
Report a problemFND-1145224904
05HumanNon-randomized trialEfficacy outcome
In GH-deficient children, serum prolactin did not change from baseline after ibutamoren.
In plain wordsIn GH-deficient children, prolactin did not change from baseline after ibutamoren.
Peptide
MK-677 (ibutamoren)
Outcome
No significant changeProlactin
Study
n: not reported in source
Comparator
Baseline
Outcome group
Pituitary hormones · Endocrine and hormones
Studied dose
0.8 mg/kg per day · oral · 8 daysAs given in this study (human).
Source sentences
Summary
There was no change in serum prolactin, glucose, triiodothyronine, thyroxine, thyrotropin, peak serum cortisol, and insulin concentrations or 24-hour urinary free cortisol after administration of 0.8 mg/kg per day of ibutamoren mesylate for 8 days.
2 context sentences(design, population, supporting numbers)
Summary · context
We evaluated the safety and tolerability and the GH-insulin-like growth factor (IGF) responses to two dosages of oral ibutamoren mesylate given to children with GH deficiency for 7 to 8 days.
Summary · context
Hormonal profiles were evaluated on day -1 (baseline) and day 15, and the results were expressed as the change from baseline within each group.
Report a problemFND-1145224905
06HumanNon-randomized trialEfficacy outcome
In GH-deficient children, glucose did not change from baseline after ibutamoren.
In plain wordsIn GH-deficient children, glucose did not change from baseline after ibutamoren.
Peptide
MK-677 (ibutamoren)
Outcome
No significant changeGlucose
Study
n: not reported in source
Comparator
Baseline
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.8 mg/kg per day · oral · 8 daysAs given in this study (human).
Source sentences
Summary
There was no change in serum prolactin, glucose, triiodothyronine, thyroxine, thyrotropin, peak serum cortisol, and insulin concentrations or 24-hour urinary free cortisol after administration of 0.8 mg/kg per day of ibutamoren mesylate for 8 days.
2 context sentences(design, population, supporting numbers)
Summary · context
We evaluated the safety and tolerability and the GH-insulin-like growth factor (IGF) responses to two dosages of oral ibutamoren mesylate given to children with GH deficiency for 7 to 8 days.
Summary · context
Hormonal profiles were evaluated on day -1 (baseline) and day 15, and the results were expressed as the change from baseline within each group.
Report a problemFND-1145224906
07HumanNon-randomized trialEfficacy outcome
In GH-deficient children, triiodothyronine did not change from baseline after ibutamoren.
In plain wordsIn GH-deficient children, triiodothyronine did not change from baseline after ibutamoren.
Peptide
MK-677 (ibutamoren)
Outcome
No significant changeTriiodothyronine
Study
n: not reported in source
Comparator
Baseline
Outcome group
Thyroid function · Endocrine and hormones
Studied dose
0.8 mg/kg per day · oral · 8 daysAs given in this study (human).
Source sentences
Summary
There was no change in serum prolactin, glucose, triiodothyronine, thyroxine, thyrotropin, peak serum cortisol, and insulin concentrations or 24-hour urinary free cortisol after administration of 0.8 mg/kg per day of ibutamoren mesylate for 8 days.
2 context sentences(design, population, supporting numbers)
Summary · context
We evaluated the safety and tolerability and the GH-insulin-like growth factor (IGF) responses to two dosages of oral ibutamoren mesylate given to children with GH deficiency for 7 to 8 days.
Summary · context
Hormonal profiles were evaluated on day -1 (baseline) and day 15, and the results were expressed as the change from baseline within each group.
Report a problemFND-1145224907
08HumanNon-randomized trialEfficacy outcome
In GH-deficient children, thyroxine did not change from baseline after ibutamoren.
In plain wordsIn GH-deficient children, thyroxine did not change from baseline after ibutamoren.
Peptide
MK-677 (ibutamoren)
Outcome
No significant changeThyroxine
Study
n: not reported in source
Comparator
Baseline
Outcome group
Thyroid function · Endocrine and hormones
Studied dose
0.8 mg/kg per day · oral · 8 daysAs given in this study (human).
Source sentences
Summary
There was no change in serum prolactin, glucose, triiodothyronine, thyroxine, thyrotropin, peak serum cortisol, and insulin concentrations or 24-hour urinary free cortisol after administration of 0.8 mg/kg per day of ibutamoren mesylate for 8 days.
2 context sentences(design, population, supporting numbers)
Summary · context
We evaluated the safety and tolerability and the GH-insulin-like growth factor (IGF) responses to two dosages of oral ibutamoren mesylate given to children with GH deficiency for 7 to 8 days.
Summary · context
Hormonal profiles were evaluated on day -1 (baseline) and day 15, and the results were expressed as the change from baseline within each group.
Report a problemFND-1145224908
09HumanNon-randomized trialEfficacy outcome
In GH-deficient children, thyrotropin did not change from baseline after ibutamoren.
In plain wordsIn GH-deficient children, thyrotropin did not change from baseline after ibutamoren.
Peptide
MK-677 (ibutamoren)
Outcome
No significant changeThyrotropin
Study
n: not reported in source
Comparator
Baseline
Outcome group
Thyroid function · Endocrine and hormones
Studied dose
0.8 mg/kg per day · oral · 8 daysAs given in this study (human).
Source sentences
Summary
There was no change in serum prolactin, glucose, triiodothyronine, thyroxine, thyrotropin, peak serum cortisol, and insulin concentrations or 24-hour urinary free cortisol after administration of 0.8 mg/kg per day of ibutamoren mesylate for 8 days.
2 context sentences(design, population, supporting numbers)
Summary · context
We evaluated the safety and tolerability and the GH-insulin-like growth factor (IGF) responses to two dosages of oral ibutamoren mesylate given to children with GH deficiency for 7 to 8 days.
Summary · context
Hormonal profiles were evaluated on day -1 (baseline) and day 15, and the results were expressed as the change from baseline within each group.
Report a problemFND-1145224909
10HumanNon-randomized trialEfficacy outcome
In GH-deficient children, peak serum cortisol did not change from baseline after ibutamoren.
In plain wordsIn GH-deficient children, peak cortisol did not change from baseline after ibutamoren.
Peptide
MK-677 (ibutamoren)
Outcome
No significant changePeak serum cortisol
Study
n: not reported in source
Comparator
Baseline
Outcome group
Stress hormones · Endocrine and hormones
Studied dose
0.8 mg/kg per day · oral · 8 daysAs given in this study (human).
Source sentences
Summary
There was no change in serum prolactin, glucose, triiodothyronine, thyroxine, thyrotropin, peak serum cortisol, and insulin concentrations or 24-hour urinary free cortisol after administration of 0.8 mg/kg per day of ibutamoren mesylate for 8 days.
2 context sentences(design, population, supporting numbers)
Summary · context
We evaluated the safety and tolerability and the GH-insulin-like growth factor (IGF) responses to two dosages of oral ibutamoren mesylate given to children with GH deficiency for 7 to 8 days.
Summary · context
Hormonal profiles were evaluated on day -1 (baseline) and day 15, and the results were expressed as the change from baseline within each group.
Report a problemFND-1145224910
11HumanNon-randomized trialEfficacy outcome
In GH-deficient children, insulin did not change from baseline after ibutamoren.
In plain wordsIn GH-deficient children, insulin did not change from baseline after ibutamoren.
Peptide
MK-677 (ibutamoren)
Outcome
No significant changeInsulin
Study
n: not reported in source
Comparator
Baseline
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.8 mg/kg per day · oral · 8 daysAs given in this study (human).
Source sentences
Summary
There was no change in serum prolactin, glucose, triiodothyronine, thyroxine, thyrotropin, peak serum cortisol, and insulin concentrations or 24-hour urinary free cortisol after administration of 0.8 mg/kg per day of ibutamoren mesylate for 8 days.
2 context sentences(design, population, supporting numbers)
Summary · context
We evaluated the safety and tolerability and the GH-insulin-like growth factor (IGF) responses to two dosages of oral ibutamoren mesylate given to children with GH deficiency for 7 to 8 days.
Summary · context
Hormonal profiles were evaluated on day -1 (baseline) and day 15, and the results were expressed as the change from baseline within each group.
Report a problemFND-1145224911
12HumanNon-randomized trialEfficacy outcome
In GH-deficient children, 24-hour urinary free cortisol did not change from baseline after ibutamoren.
In plain wordsIn GH-deficient children, urinary free cortisol did not change from baseline after ibutamoren.
Peptide
MK-677 (ibutamoren)
Outcome
No significant changeUrinary free cortisol
Study
n: not reported in source
Comparator
Baseline
Outcome group
Stress hormones · Endocrine and hormones
Studied dose
0.8 mg/kg per day · oral · 8 daysAs given in this study (human).
Source sentences
Summary
There was no change in serum prolactin, glucose, triiodothyronine, thyroxine, thyrotropin, peak serum cortisol, and insulin concentrations or 24-hour urinary free cortisol after administration of 0.8 mg/kg per day of ibutamoren mesylate for 8 days.
2 context sentences(design, population, supporting numbers)
Summary · context
We evaluated the safety and tolerability and the GH-insulin-like growth factor (IGF) responses to two dosages of oral ibutamoren mesylate given to children with GH deficiency for 7 to 8 days.
Summary · context
Hormonal profiles were evaluated on day -1 (baseline) and day 15, and the results were expressed as the change from baseline within each group.
Report a problemFND-1145224912

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Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
14 Oct 2026, 05:02 UTC
Study results updated
Version 1
14 Oct 2026, 01:46 UTC
First added · source update from Europe PMC

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