Clinical pharmacodynamic effects of the growth hormone receptor antagonist pegvisomant: implications for cancer therapy.

Yin D, Vreeland F, Schaaf LJ, Millham R, Duncan BA, Sharma A

Clinical cancer research : an official journal of the American Association for Cancer Research1 Feb 2007Cited by 47 (Europe PMC)

PMID17289896DOI10.1158/1078-0432.ccr-06-1910PepBankPUB-17289896

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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 study16

16 results from studies that gave the peptide. 16 results from people.

01HumanNon-randomized trialEfficacy outcome
In healthy subjects, pegvisomant 40 mg daily produced mean maximum total IGF-I suppression of 57%.
In plain wordsIn healthy subjects, pegvisomant 40 mg daily lowered total IGF-I by a maximum mean of 57% from baseline.
Peptide
Pegvisomant
Outcome
DecreaseMaximum total IGF-I suppression at 40 mg
Study
n = 18
Comparator
Baseline
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
40 mg once daily · subcutaneous · 14 daysAs given in this study (human).
Measurements
Maximum IGF-I suppression
57%
40 mg
Source sentences
Summary
After s.c. dosing of pegvisomant once daily for 14 days, the mean maximum suppression values of total IGF-I were 57%, 60%, and 62%, at 40, 60, and 80 mg dose levels, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
Eighty healthy subjects were enrolled in five cohorts: cohorts 1 to 3, s.c. pegvisomant at 40, 60, or 80 mg once dailyx14 days (n=18 per cohort); cohort 4, s.c. octreotide at 200 microg thrice dailyx14 days (n=18); and cohort 5, untreated control (n=8).
Report a problemFND-1728989601
02HumanNon-randomized trialEfficacy outcome
In healthy subjects, pegvisomant 60 mg daily produced mean maximum total IGF-I suppression of 60%.
In plain wordsIn healthy subjects, pegvisomant 60 mg daily lowered total IGF-I by a maximum mean of 60% from baseline.
Peptide
Pegvisomant
Outcome
DecreaseMaximum total IGF-I suppression at 60 mg
Study
n = 18
Comparator
Baseline
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
60 mg once daily · subcutaneous · 14 daysAs given in this study (human).
Measurements
Maximum IGF-I suppression
60%
60 mg
Source sentences
Summary
After s.c. dosing of pegvisomant once daily for 14 days, the mean maximum suppression values of total IGF-I were 57%, 60%, and 62%, at 40, 60, and 80 mg dose levels, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
Eighty healthy subjects were enrolled in five cohorts: cohorts 1 to 3, s.c. pegvisomant at 40, 60, or 80 mg once dailyx14 days (n=18 per cohort); cohort 4, s.c. octreotide at 200 microg thrice dailyx14 days (n=18); and cohort 5, untreated control (n=8).
Report a problemFND-1728989602
03HumanNon-randomized trialEfficacy outcome
In healthy subjects, pegvisomant 80 mg daily produced mean maximum total IGF-I suppression of 62%.
In plain wordsIn healthy subjects, pegvisomant 80 mg daily lowered total IGF-I by a maximum mean of 62% from baseline.
Peptide
Pegvisomant
Outcome
DecreaseMaximum total IGF-I suppression at 80 mg
Study
n = 18
Comparator
Baseline
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
80 mg once daily · subcutaneous · 14 daysAs given in this study (human).
Measurements
Maximum IGF-I suppression
62%
80 mg
Source sentences
Summary
After s.c. dosing of pegvisomant once daily for 14 days, the mean maximum suppression values of total IGF-I were 57%, 60%, and 62%, at 40, 60, and 80 mg dose levels, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
Eighty healthy subjects were enrolled in five cohorts: cohorts 1 to 3, s.c. pegvisomant at 40, 60, or 80 mg once dailyx14 days (n=18 per cohort); cohort 4, s.c. octreotide at 200 microg thrice dailyx14 days (n=18); and cohort 5, untreated control (n=8).
Report a problemFND-1728989603
04HumanNon-randomized trialActivity measurement
In healthy subjects, maximum IGF-I suppression with pegvisomant occurred approximately 7 days after the last dose.
In plain wordsIn healthy subjects, pegvisomant produced maximum IGF-I suppression approximately seven days after the last dose.
Peptide
Pegvisomant
Outcome
Not applicableTime to maximum IGF-I suppression
Study
n: not reported in source
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
40, 60, or 80 mg once daily · subcutaneous · 14 daysAs given in this study (human).
Measurements
Time to maximum suppression
≈ 7 days
after last dose
Source sentences
Summary
The maximum suppression was achieved approximately 7 days after the last dose and was sustained for approximately 21 days.
2 context sentences(design, population, supporting numbers)
Summary · context
After s.c. dosing of pegvisomant once daily for 14 days, the mean maximum suppression values of total IGF-I were 57%, 60%, and 62%, at 40, 60, and 80 mg dose levels, respectively.
Summary · context
Eighty healthy subjects were enrolled in five cohorts: cohorts 1 to 3, s.c. pegvisomant at 40, 60, or 80 mg once dailyx14 days (n=18 per cohort); cohort 4, s.c. octreotide at 200 microg thrice dailyx14 days (n=18); and cohort 5, untreated control (n=8).
Report a problemFND-1728989604
05HumanNon-randomized trialActivity measurement
In healthy subjects, maximum IGF-I suppression with pegvisomant persisted for approximately 21 days.
In plain wordsIn healthy subjects, maximum IGF-I suppression with pegvisomant persisted for approximately 21 days.
Peptide
Pegvisomant
Outcome
Not applicableDuration of maximum IGF-I suppression
Study
n: not reported in source
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
40, 60, or 80 mg once daily · subcutaneous · 14 daysAs given in this study (human).
Measurements
Suppression duration
≈ 21 days
reported result
Source sentences
Summary
The maximum suppression was achieved approximately 7 days after the last dose and was sustained for approximately 21 days.
2 context sentences(design, population, supporting numbers)
Summary · context
After s.c. dosing of pegvisomant once daily for 14 days, the mean maximum suppression values of total IGF-I were 57%, 60%, and 62%, at 40, 60, and 80 mg dose levels, respectively.
Summary · context
Eighty healthy subjects were enrolled in five cohorts: cohorts 1 to 3, s.c. pegvisomant at 40, 60, or 80 mg once dailyx14 days (n=18 per cohort); cohort 4, s.c. octreotide at 200 microg thrice dailyx14 days (n=18); and cohort 5, untreated control (n=8).
Report a problemFND-1728989605
06HumanNon-randomized trialEfficacy outcome
In healthy subjects, pegvisomant produced a sustained reduction in free IGF-I by up to 33%.
In plain wordsIn healthy subjects, pegvisomant lowered free IGF-I by up to 33% from baseline.
Peptide
Pegvisomant
Outcome
DecreaseFree IGF-I reduction
Study
n: not reported in source
Comparator
Baseline
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
40, 60, or 80 mg once daily · subcutaneous · 14 daysAs given in this study (human).
Measurements
Free IGF-I reduction
≤ 33%
reported result
Source sentences
Summary
Pegvisomant also led to a sustained reduction in free IGF-I, IGFBP-3, and IGF-II concentrations by up to 33%, 46%, and 35%, respectively, and an increase in GH levels.
1 context sentence(design, population, supporting numbers)
Summary · context
Eighty healthy subjects were enrolled in five cohorts: cohorts 1 to 3, s.c. pegvisomant at 40, 60, or 80 mg once dailyx14 days (n=18 per cohort); cohort 4, s.c. octreotide at 200 microg thrice dailyx14 days (n=18); and cohort 5, untreated control (n=8).
Report a problemFND-1728989606
07HumanNon-randomized trialEfficacy outcome
In healthy subjects, pegvisomant produced a sustained reduction in IGFBP-3 by up to 46%.
In plain wordsIn healthy subjects, pegvisomant lowered IGFBP-3 by up to 46% from baseline.
Peptide
Pegvisomant
Outcome
DecreaseIGFBP-3 reduction
Study
n: not reported in source
Comparator
Baseline
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
40, 60, or 80 mg once daily · subcutaneous · 14 daysAs given in this study (human).
Measurements
IGFBP-3 reduction
≤ 46%
reported result
Source sentences
Summary
Pegvisomant also led to a sustained reduction in free IGF-I, IGFBP-3, and IGF-II concentrations by up to 33%, 46%, and 35%, respectively, and an increase in GH levels.
1 context sentence(design, population, supporting numbers)
Summary · context
Eighty healthy subjects were enrolled in five cohorts: cohorts 1 to 3, s.c. pegvisomant at 40, 60, or 80 mg once dailyx14 days (n=18 per cohort); cohort 4, s.c. octreotide at 200 microg thrice dailyx14 days (n=18); and cohort 5, untreated control (n=8).
Report a problemFND-1728989607
08HumanNon-randomized trialEfficacy outcome
In healthy subjects, pegvisomant produced a sustained reduction in IGF-II by up to 35%.
In plain wordsIn healthy subjects, pegvisomant lowered IGF-II by up to 35% from baseline.
Peptide
Pegvisomant
Outcome
DecreaseIGF-II reduction
Study
n: not reported in source
Comparator
Baseline
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
40, 60, or 80 mg once daily · subcutaneous · 14 daysAs given in this study (human).
Measurements
IGF-II reduction
≤ 35%
reported result
Source sentences
Summary
Pegvisomant also led to a sustained reduction in free IGF-I, IGFBP-3, and IGF-II concentrations by up to 33%, 46%, and 35%, respectively, and an increase in GH levels.
1 context sentence(design, population, supporting numbers)
Summary · context
Eighty healthy subjects were enrolled in five cohorts: cohorts 1 to 3, s.c. pegvisomant at 40, 60, or 80 mg once dailyx14 days (n=18 per cohort); cohort 4, s.c. octreotide at 200 microg thrice dailyx14 days (n=18); and cohort 5, untreated control (n=8).
Report a problemFND-1728989608
09HumanNon-randomized trialEfficacy outcome
In healthy subjects, pegvisomant increased GH levels.
In plain wordsIn healthy subjects, pegvisomant raised growth hormone levels from baseline.
Peptide
Pegvisomant
Outcome
IncreaseGH increase
Study
n: not reported in source
Comparator
Baseline
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
40, 60, or 80 mg once daily · subcutaneous · 14 daysAs given in this study (human).
Source sentences
Summary
Pegvisomant also led to a sustained reduction in free IGF-I, IGFBP-3, and IGF-II concentrations by up to 33%, 46%, and 35%, respectively, and an increase in GH levels.
1 context sentence(design, population, supporting numbers)
Summary · context
Eighty healthy subjects were enrolled in five cohorts: cohorts 1 to 3, s.c. pegvisomant at 40, 60, or 80 mg once dailyx14 days (n=18 per cohort); cohort 4, s.c. octreotide at 200 microg thrice dailyx14 days (n=18); and cohort 5, untreated control (n=8).
Report a problemFND-1728989609
10HumanNon-randomized trialEfficacy outcome
In healthy subjects, pegvisomant inhibited total IGF-I more strongly and for longer than octreotide.
In plain wordsIn healthy subjects, pegvisomant lowered total IGF-I more strongly and for longer than octreotide.
Peptide
Pegvisomant
Outcome
DecreaseTotal IGF-I inhibition versus octreotide
Study
n: not reported in source
Comparator
Octreotide
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
40, 60, or 80 mg once daily · subcutaneous · 14 daysAs given in this study (human).
Source sentences
Summary
In comparison, octreotide resulted in a considerably weaker inhibition of total IGF-I and IGFBP-3 for a much shorter duration, and no inhibition of IGF-II.
2 context sentences(design, population, supporting numbers)
Summary · context
After s.c. dosing of pegvisomant once daily for 14 days, the mean maximum suppression values of total IGF-I were 57%, 60%, and 62%, at 40, 60, and 80 mg dose levels, respectively.
Summary · context
Eighty healthy subjects were enrolled in five cohorts: cohorts 1 to 3, s.c. pegvisomant at 40, 60, or 80 mg once dailyx14 days (n=18 per cohort); cohort 4, s.c. octreotide at 200 microg thrice dailyx14 days (n=18); and cohort 5, untreated control (n=8).
Report a problemFND-1728989610
11HumanNon-randomized trialEfficacy outcome
In healthy subjects, pegvisomant inhibited IGFBP-3 more strongly and for longer than octreotide.
In plain wordsIn healthy subjects, pegvisomant lowered IGFBP-3 more strongly and for longer than octreotide.
Peptide
Pegvisomant
Outcome
DecreaseIGFBP-3 inhibition versus octreotide
Study
n: not reported in source
Comparator
Octreotide
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
40, 60, or 80 mg once daily · subcutaneous · 14 daysAs given in this study (human).
Source sentences
Summary
In comparison, octreotide resulted in a considerably weaker inhibition of total IGF-I and IGFBP-3 for a much shorter duration, and no inhibition of IGF-II.
2 context sentences(design, population, supporting numbers)
Summary · context
Pegvisomant also led to a sustained reduction in free IGF-I, IGFBP-3, and IGF-II concentrations by up to 33%, 46%, and 35%, respectively, and an increase in GH levels.
Summary · context
Eighty healthy subjects were enrolled in five cohorts: cohorts 1 to 3, s.c. pegvisomant at 40, 60, or 80 mg once dailyx14 days (n=18 per cohort); cohort 4, s.c. octreotide at 200 microg thrice dailyx14 days (n=18); and cohort 5, untreated control (n=8).
Report a problemFND-1728989611
12HumanNon-randomized trialEfficacy outcome
In healthy subjects, pegvisomant reduced IGF-II whereas octreotide did not inhibit IGF-II.
In plain wordsIn healthy subjects, pegvisomant lowered IGF-II, whereas octreotide did not.
Peptide
Pegvisomant
Outcome
DecreaseIGF-II inhibition versus octreotide
Study
n: not reported in source
Comparator
Octreotide
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
40, 60, or 80 mg once daily · subcutaneous · 14 daysAs given in this study (human).
Source sentences
Summary
Pegvisomant also led to a sustained reduction in free IGF-I, IGFBP-3, and IGF-II concentrations by up to 33%, 46%, and 35%, respectively, and an increase in GH levels. In comparison, octreotide resulted in a considerably weaker inhibition of total IGF-I and IGFBP-3 for a much shorter duration, and n…
1 context sentence(design, population, supporting numbers)
Summary · context
Eighty healthy subjects were enrolled in five cohorts: cohorts 1 to 3, s.c. pegvisomant at 40, 60, or 80 mg once dailyx14 days (n=18 per cohort); cohort 4, s.c. octreotide at 200 microg thrice dailyx14 days (n=18); and cohort 5, untreated control (n=8).
Report a problemFND-1728989612
13HumanNon-randomized trialSafety outcome
In healthy subjects receiving pegvisomant, adverse events were generally grade 1 or 2.
In plain wordsIn healthy subjects receiving pegvisomant, adverse events were generally grade 1 or 2.
Peptide
Pegvisomant
Outcome
Not applicableAdverse event grades
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
40, 60, or 80 mg once daily · subcutaneous · 14 daysAs given in this study (human).
Source sentences
Summary
AEs in pegvisomant-treated subjects were generally either grade 1 or 2.
1 context sentence(design, population, supporting numbers)
Summary · context
Eighty healthy subjects were enrolled in five cohorts: cohorts 1 to 3, s.c. pegvisomant at 40, 60, or 80 mg once dailyx14 days (n=18 per cohort); cohort 4, s.c. octreotide at 200 microg thrice dailyx14 days (n=18); and cohort 5, untreated control (n=8).
Report a problemFND-1728989613
14HumanNon-randomized trialSafety outcome
In healthy subjects receiving pegvisomant, injection site reactions were among the most frequent treatment-related adverse events.
In plain wordsIn healthy subjects receiving pegvisomant, injection site reactions were among the most frequent treatment-related adverse events.
Peptide
Pegvisomant
Outcome
Not applicableInjection site reactions
Study
n: not reported in source
Outcome group
Adverse events · Skin and wound
Studied dose
40, 60, or 80 mg once daily · subcutaneous · 14 daysAs given in this study (human).
Source sentences
Summary
The most frequent treatment-related AEs included injection site reactions, headache, and fatigue.
2 context sentences(design, population, supporting numbers)
Summary · context
AEs in pegvisomant-treated subjects were generally either grade 1 or 2.
Summary · context
Eighty healthy subjects were enrolled in five cohorts: cohorts 1 to 3, s.c. pegvisomant at 40, 60, or 80 mg once dailyx14 days (n=18 per cohort); cohort 4, s.c. octreotide at 200 microg thrice dailyx14 days (n=18); and cohort 5, untreated control (n=8).
Report a problemFND-1728989614
15HumanNon-randomized trialSafety outcome
In healthy subjects receiving pegvisomant, headache was among the most frequent treatment-related adverse events.
In plain wordsIn healthy subjects receiving pegvisomant, headache was among the most frequent treatment-related adverse events.
Peptide
Pegvisomant
Outcome
Not applicableHeadache
Study
n: not reported in source
Outcome group
Adverse events · Nervous system and cognition
Studied dose
40, 60, or 80 mg once daily · subcutaneous · 14 daysAs given in this study (human).
Source sentences
Summary
The most frequent treatment-related AEs included injection site reactions, headache, and fatigue.
2 context sentences(design, population, supporting numbers)
Summary · context
AEs in pegvisomant-treated subjects were generally either grade 1 or 2.
Summary · context
Eighty healthy subjects were enrolled in five cohorts: cohorts 1 to 3, s.c. pegvisomant at 40, 60, or 80 mg once dailyx14 days (n=18 per cohort); cohort 4, s.c. octreotide at 200 microg thrice dailyx14 days (n=18); and cohort 5, untreated control (n=8).
Report a problemFND-1728989615
16HumanNon-randomized trialSafety outcome
In healthy subjects receiving pegvisomant, fatigue was among the most frequent treatment-related adverse events.
In plain wordsIn healthy subjects receiving pegvisomant, fatigue was among the most frequent treatment-related adverse events.
Peptide
Pegvisomant
Outcome
Not applicableFatigue
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
40, 60, or 80 mg once daily · subcutaneous · 14 daysAs given in this study (human).
Source sentences
Summary
The most frequent treatment-related AEs included injection site reactions, headache, and fatigue.
2 context sentences(design, population, supporting numbers)
Summary · context
AEs in pegvisomant-treated subjects were generally either grade 1 or 2.
Summary · context
Eighty healthy subjects were enrolled in five cohorts: cohorts 1 to 3, s.c. pegvisomant at 40, 60, or 80 mg once dailyx14 days (n=18 per cohort); cohort 4, s.c. octreotide at 200 microg thrice dailyx14 days (n=18); and cohort 5, untreated control (n=8).
Report a problemFND-1728989616

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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
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:34 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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