Treatment of acromegaly with the growth hormone-receptor antagonist pegvisomant.

Trainer PJ, Drake WM, Katznelson L, Freda PU, Herman-Bonert V, van der Lely AJ, Dimaraki EV, Stewart PM, Friend KE, Vance ML, Besser GM, Scarlett JA and 21 more

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Thorner MO, Parkinson C, Klibanski A, Powell JS, Barkan AL, Sheppard MC, Malsonado M, Rose DR, Clemmons DR, Johannsson G, Bengtsson BA, Stavrou S, Kleinberg DL, Cook DM, Phillips LS, Bidlingmaier M, Strasburger CJ, Hackett S, Zib K, Bennett WF, Davis RJ

The New England journal of medicine1 Apr 2000Cited by 503 (Europe PMC)

PMID10770982DOI10.1056/nejm200004203421604PepBankPUB-10770982

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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 study11

11 results from studies that gave the peptide. 11 results from people.

01HumanRandomized controlled trialSafety outcome
In acromegaly, adverse effect incidence was similar across pegvisomant and placebo groups.
In plain wordsIn acromegaly, adverse effect incidence was similar with pegvisomant and placebo.
Peptide
Pegvisomant
Outcome
Direction not reportedAdverse effects incidence
Study
n = 112
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
10, 15, or 20 mg daily · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
The incidence of adverse effects was similar in all groups.
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a 12-week, randomized, double-blind study of three daily doses of pegvisomant (10 mg, 15 mg, and 20 mg) and placebo, given subcutaneously, in 112 patients with acromegaly.
Report a problemFND-1077098209
02HumanRandomized controlled trialEfficacy outcome
In acromegaly, pegvisomant 10 mg daily reduced IGF-I by 26.7+/-27.9 percent versus 4.0+/-16.8 percent with placebo (P<0.001).
In plain wordsIn acromegaly, pegvisomant 10 mg daily reduced IGF-I more than placebo.
Peptide
Pegvisomant
Outcome
DecreaseIGF-I reduction
Study
n: not reported in source
Comparator
Placebo
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
10 mg daily · subcutaneous · 12 weeksAs given in this study (human).
Measurements
IGF-I decrease from baseline
26.7 percent
pegvisomant 10 mg/day (+/-27.9)
IGF-I decrease from baseline
4 percent
placebo (+/-16.8)
Source sentences
Summary
The mean (+/-SD) serum concentration of insulin-like growth factor I (IGF-I) decreased from base line by 4.0+/-16.8 percent in the placebo group, 26.7+/-27.9 percent in the group that received 10 mg of pegvisomant per day
2 context sentences(design, population, supporting numbers)
Summary · context
(P<0.001 for the comparison of each pegvisomant group with placebo)
Summary · context
We conducted a 12-week, randomized, double-blind study of three daily doses of pegvisomant (10 mg, 15 mg, and 20 mg) and placebo, given subcutaneously, in 112 patients with acromegaly.
Report a problemFND-1077098201
03HumanRandomized controlled trialEfficacy outcome
In acromegaly, pegvisomant 15 mg daily reduced IGF-I by 50.1+/-26.7 percent versus 4.0+/-16.8 percent with placebo (P<0.001).
In plain wordsIn acromegaly, pegvisomant 15 mg daily reduced IGF-I more than placebo.
Peptide
Pegvisomant
Outcome
DecreaseIGF-I reduction
Study
n: not reported in source
Comparator
Placebo
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
15 mg daily · subcutaneous · 12 weeksAs given in this study (human).
Measurements
IGF-I decrease from baseline
50.1 percent
pegvisomant 15 mg/day (+/-26.7)
IGF-I decrease from baseline
4 percent
placebo (+/-16.8)
Source sentences
Summary
50.1+/-26.7 percent in the group that received 15 mg of pegvisomant per day
3 context sentences(design, population, supporting numbers)
Summary · context
The mean (+/-SD) serum concentration of insulin-like growth factor I (IGF-I) decreased from base line by 4.0+/-16.8 percent in the placebo group
Summary · context
(P<0.001 for the comparison of each pegvisomant group with placebo)
Summary · context
We conducted a 12-week, randomized, double-blind study of three daily doses of pegvisomant (10 mg, 15 mg, and 20 mg) and placebo, given subcutaneously, in 112 patients with acromegaly.
Report a problemFND-1077098202
04HumanRandomized controlled trialEfficacy outcome
In acromegaly, pegvisomant 20 mg daily reduced IGF-I by 62.5+/-21.3 percent versus 4.0+/-16.8 percent with placebo (P<0.001).
In plain wordsIn acromegaly, pegvisomant 20 mg daily reduced IGF-I more than placebo.
Peptide
Pegvisomant
Outcome
DecreaseIGF-I reduction
Study
n: not reported in source
Comparator
Placebo
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
20 mg daily · subcutaneous · 12 weeksAs given in this study (human).
Measurements
IGF-I decrease from baseline
62.5 percent
pegvisomant 20 mg/day (+/-21.3)
IGF-I decrease from baseline
4 percent
placebo (+/-16.8)
Source sentences
Summary
62.5+/-21.3 percent in the group that received 20 mg of pegvisomant per day (P<0.001 for the comparison of each pegvisomant group with placebo)
2 context sentences(design, population, supporting numbers)
Summary · context
The mean (+/-SD) serum concentration of insulin-like growth factor I (IGF-I) decreased from base line by 4.0+/-16.8 percent in the placebo group
Summary · context
We conducted a 12-week, randomized, double-blind study of three daily doses of pegvisomant (10 mg, 15 mg, and 20 mg) and placebo, given subcutaneously, in 112 patients with acromegaly.
Report a problemFND-1077098203
05HumanRandomized controlled trialEfficacy outcome
In acromegaly, IGF-I normalized in 54 percent with pegvisomant 10 mg daily versus 10 percent with placebo (P<0.001).
In plain wordsIn acromegaly, pegvisomant 10 mg daily normalized IGF-I more often than placebo.
Peptide
Pegvisomant
Outcome
IncreaseIGF-I normalization
Study
n: not reported in source
Comparator
Placebo
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
10 mg daily · subcutaneous · 12 weeksAs given in this study (human).
Measurements
Patients with normalized IGF-I
54 percent
pegvisomant 10 mg/day
Patients with normalized IGF-I
10 percent
placebo
Source sentences
Summary
and the concentrations became normal in 10 percent, 54 percent, 81 percent, and 89 percent of patients, respectively (P<0.001 for each comparison with placebo).
2 context sentences(design, population, supporting numbers)
Summary · context
We conducted a 12-week, randomized, double-blind study of three daily doses of pegvisomant (10 mg, 15 mg, and 20 mg) and placebo, given subcutaneously, in 112 patients with acromegaly.
Summary · context
4.0+/-16.8 percent in the placebo group, 26.7+/-27.9 percent in the group that received 10 mg of pegvisomant per day, 50.1+/-26.7 percent in the group that received 15 mg of pegvisomant per day, and 62.5+/-21.3 percent in the group that received 20 mg of pegvisomant per day
Report a problemFND-1077098204
06HumanRandomized controlled trialEfficacy outcome
In acromegaly, IGF-I normalized in 81 percent with pegvisomant 15 mg daily versus 10 percent with placebo (P<0.001).
In plain wordsIn acromegaly, pegvisomant 15 mg daily normalized IGF-I more often than placebo.
Peptide
Pegvisomant
Outcome
IncreaseIGF-I normalization
Study
n: not reported in source
Comparator
Placebo
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
15 mg daily · subcutaneous · 12 weeksAs given in this study (human).
Measurements
Patients with normalized IGF-I
81 percent
pegvisomant 15 mg/day
Patients with normalized IGF-I
10 percent
placebo
Source sentences
Summary
and the concentrations became normal in 10 percent, 54 percent, 81 percent, and 89 percent of patients, respectively (P<0.001 for each comparison with placebo).
2 context sentences(design, population, supporting numbers)
Summary · context
We conducted a 12-week, randomized, double-blind study of three daily doses of pegvisomant (10 mg, 15 mg, and 20 mg) and placebo, given subcutaneously, in 112 patients with acromegaly.
Summary · context
4.0+/-16.8 percent in the placebo group, 26.7+/-27.9 percent in the group that received 10 mg of pegvisomant per day, 50.1+/-26.7 percent in the group that received 15 mg of pegvisomant per day, and 62.5+/-21.3 percent in the group that received 20 mg of pegvisomant per day
Report a problemFND-1077098205
07HumanRandomized controlled trialEfficacy outcome
In acromegaly, IGF-I normalized in 89 percent with pegvisomant 20 mg daily versus 10 percent with placebo (P<0.001).
In plain wordsIn acromegaly, pegvisomant 20 mg daily normalized IGF-I more often than placebo.
Peptide
Pegvisomant
Outcome
IncreaseIGF-I normalization
Study
n: not reported in source
Comparator
Placebo
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
20 mg daily · subcutaneous · 12 weeksAs given in this study (human).
Measurements
Patients with normalized IGF-I
89 percent
pegvisomant 20 mg/day
Patients with normalized IGF-I
10 percent
placebo
Source sentences
Summary
and the concentrations became normal in 10 percent, 54 percent, 81 percent, and 89 percent of patients, respectively (P<0.001 for each comparison with placebo).
2 context sentences(design, population, supporting numbers)
Summary · context
We conducted a 12-week, randomized, double-blind study of three daily doses of pegvisomant (10 mg, 15 mg, and 20 mg) and placebo, given subcutaneously, in 112 patients with acromegaly.
Summary · context
4.0+/-16.8 percent in the placebo group, 26.7+/-27.9 percent in the group that received 10 mg of pegvisomant per day, 50.1+/-26.7 percent in the group that received 15 mg of pegvisomant per day, and 62.5+/-21.3 percent in the group that received 20 mg of pegvisomant per day
Report a problemFND-1077098206
08HumanNon-randomized trialEfficacy outcome
In acromegaly, ring size, soft-tissue swelling, excessive perspiration, and fatigue decreased significantly among patients receiving pegvisomant 15 mg or 20 mg daily.
In plain wordsIn acromegaly, ring size, swelling, perspiration, and fatigue decreased during pegvisomant treatment.
Peptide
Pegvisomant
Outcome
DecreaseRing size, swelling, perspiration and fatigue
Study
n: not reported in source
Comparator
Baseline
Outcome group
Acromegaly Symptoms and Signs · Endocrine and hormones
Studied dose
15 or 20 mg daily · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
Among patients treated with 15 mg or 20 mg of pegvisomant per day, there were significant decreases in ring size, soft-tissue swelling, the degree of excessive perspiration, and fatigue.
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a 12-week, randomized, double-blind study of three daily doses of pegvisomant (10 mg, 15 mg, and 20 mg) and placebo, given subcutaneously, in 112 patients with acromegaly.
Report a problemFND-1077098207
09HumanNon-randomized trialEfficacy outcome
In acromegaly, total symptom and sign scores decreased significantly during pegvisomant 10 mg daily treatment (P< or =0.05).
In plain wordsIn acromegaly, total symptom and sign scores decreased from baseline during pegvisomant 10 mg daily treatment.
Peptide
Pegvisomant
Outcome
DecreaseTotal symptom and sign score
Study
n: not reported in source
Comparator
Baseline
Outcome group
Acromegaly Symptoms and Signs · Endocrine and hormones
Studied dose
10 mg daily · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
The score fortotal symptoms and signs of acromegaly decreased significantly in all groups receiving pegvisomant (P< or =0.05).
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a 12-week, randomized, double-blind study of three daily doses of pegvisomant (10 mg, 15 mg, and 20 mg) and placebo, given subcutaneously, in 112 patients with acromegaly.
Report a problemFND-1077098208
10HumanNon-randomized trialEfficacy outcome
In acromegaly, total symptom and sign scores decreased significantly during pegvisomant 15 mg daily treatment (P< or =0.05).
In plain wordsIn acromegaly, total symptom and sign scores decreased from baseline during pegvisomant 15 mg daily treatment.
Peptide
Pegvisomant
Outcome
DecreaseTotal symptom and sign score
Study
n: not reported in source
Comparator
Baseline
Outcome group
Acromegaly Symptoms and Signs · Endocrine and hormones
Studied dose
15 mg daily · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
The score fortotal symptoms and signs of acromegaly decreased significantly in all groups receiving pegvisomant (P< or =0.05).
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a 12-week, randomized, double-blind study of three daily doses of pegvisomant (10 mg, 15 mg, and 20 mg) and placebo, given subcutaneously, in 112 patients with acromegaly.
Report a problemFND-1077098210
11HumanNon-randomized trialEfficacy outcome
In acromegaly, total symptom and sign scores decreased significantly during pegvisomant 20 mg daily treatment (P< or =0.05).
In plain wordsIn acromegaly, total symptom and sign scores decreased from baseline during pegvisomant 20 mg daily treatment.
Peptide
Pegvisomant
Outcome
DecreaseTotal symptom and sign score
Study
n: not reported in source
Comparator
Baseline
Outcome group
Acromegaly Symptoms and Signs · Endocrine and hormones
Studied dose
20 mg daily · subcutaneous · 12 weeksAs given in this study (human).
Source sentences
Summary
The score fortotal symptoms and signs of acromegaly decreased significantly in all groups receiving pegvisomant (P< or =0.05).
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a 12-week, randomized, double-blind study of three daily doses of pegvisomant (10 mg, 15 mg, and 20 mg) and placebo, given subcutaneously, in 112 patients with acromegaly.
Report a problemFND-1077098211

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3NCT03882034

Safety and Efficacy of Pegvisomant in Children With Growth Hormone Excess

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)n = 1221 Oct 2019 to 30 Sept 2025

Pituitary Disease

Trial page ClinicalTrials.govUpdated 6 Nov 2025

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

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Terms as the source lists them.

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