Rapid and sustained reduction of serum growth hormone and insulin-like growth factor-1 in patients with acromegaly receiving lanreotide Autogel therapy: a randomized, placebo-controlled, multicenter study with a 52 week open extension.

Melmed S, Cook D, Schopohl J, Goth MI, Lam KS, Marek J

Pituitary29 Jul 2009Cited by 86 (Europe PMC)

PMID19639415PMCIDPMC2807598DOI10.1007/s11102-009-0191-1PepBankPUB-19639415

Read at source PubMedAsk about this study

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: CC BY-NC. Results still quote short attributed sentences.

Results from this study11

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

01HumanRandomized controlled trialEfficacy outcome
In acromegaly, GH decreased by >50% in 63% receiving lanreotide versus 0% receiving placebo, P < 0.001.
In plain wordsIn acromegaly, lanreotide produced a large growth hormone reduction more often than placebo.
Peptide
Lanreotide
Outcome
DecreaseGH reduction greater than half at four weeks
Study
n: not reported in source
Comparator
Placebo
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
60, 90 or 120 mg, single randomized dose · 4 weeksAs given in this study (human).
Measurements
Patients with GH decrease >50% from baseline
63%
lanreotide, 4 weeks after first injection
Patients with GH decrease >50% from baseline
0%
placebo, 4 weeks after first injection
Source sentences
Summary
Four weeks after the first injection, serum GH levels decreased by >50% from baseline in 63% of patients receiving Lan-Autogel compared with 0% receiving placebo (P < 0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
The study was designed to evaluate the long-term efficacy and safety of the 28-day prolonged-release Autogel formulation of the somatostatin analogue lanreotide (Lan-Autogel) in unselected patients with acromegaly.
Summary · context
The study comprised four phases: washout; a double-blind comparison with placebo, at a single randomized dose (60, 90 or 120 mg) of Lan-Autogel; a single-blind, fixed-dose phase for four injections (placebo group was re-allocated to active treatment); and eight injections with doses tailored accordi…
Report a problemFND-1963941501
02HumanNon-randomized trialSafety outcome
In acromegaly, lanreotide was well tolerated by all patients.
In plain wordsIn acromegaly, all patients tolerated lanreotide well.
Peptide
Lanreotide
Outcome
Not applicableTolerability
Study
n = 108
Outcome group
Adverse events · Whole body
Studied dose
60, 90 or 120 mg, adjusted according to responseAs given in this study (human).
Source sentences
Summary
Treatment was well tolerated by all patients.
2 context sentences(design, population, supporting numbers)
Summary · context
The study was designed to evaluate the long-term efficacy and safety of the 28-day prolonged-release Autogel formulation of the somatostatin analogue lanreotide (Lan-Autogel) in unselected patients with acromegaly.
Summary · context
The study comprised four phases: washout; a double-blind comparison with placebo, at a single randomized dose (60, 90 or 120 mg) of Lan-Autogel; a single-blind, fixed-dose phase for four injections (placebo group was re-allocated to active treatment); and eight injections with doses tailored accordi…
Report a problemFND-1963941511
03HumanNon-randomized trialEfficacy outcome
In acromegaly, 72% had a >50% GH reduction after four lanreotide injections.
In plain wordsIn acromegaly, 72% had a large growth hormone reduction after four lanreotide injections.
Peptide
Lanreotide
Outcome
DecreaseGH reduction greater than half after four injections
Study
n: not reported in source
Comparator
Baseline
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
60, 90 or 120 mg, fixed-dose phaseAs given in this study (human).
Measurements
Patients with GH reduction >50%
72%
after four injections
Source sentences
Summary
After four injections, 72% of patients had a >50% reduction in GH levels; 49% patients achieved GH levels < or = 2.5 ng/ml; 54% had normalized IGF-1; and 38% achieved the combined criterion of GH level < or = 2.5 ng/ml and normalized IGF-1.
2 context sentences(design, population, supporting numbers)
Summary · context
The study was designed to evaluate the long-term efficacy and safety of the 28-day prolonged-release Autogel formulation of the somatostatin analogue lanreotide (Lan-Autogel) in unselected patients with acromegaly.
Summary · context
The study comprised four phases: washout; a double-blind comparison with placebo, at a single randomized dose (60, 90 or 120 mg) of Lan-Autogel; a single-blind, fixed-dose phase for four injections (placebo group was re-allocated to active treatment); and eight injections with doses tailored accordi…
Report a problemFND-1963941502
04HumanNon-randomized trialEfficacy outcome
In acromegaly, 49% achieved GH levels at or below 2.5 ng/ml after four lanreotide injections.
In plain wordsIn acromegaly, 49% reached the growth hormone threshold after four lanreotide injections.
Peptide
Lanreotide
Outcome
Not applicableGH biochemical threshold after four injections
Study
n: not reported in source
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
60, 90 or 120 mg, fixed-dose phaseAs given in this study (human).
Measurements
Patients with GH <= 2.5 ng/ml
49%
after four injections
Source sentences
Summary
After four injections, 72% of patients had a >50% reduction in GH levels; 49% patients achieved GH levels < or = 2.5 ng/ml; 54% had normalized IGF-1; and 38% achieved the combined criterion of GH level < or = 2.5 ng/ml and normalized IGF-1.
2 context sentences(design, population, supporting numbers)
Summary · context
The study was designed to evaluate the long-term efficacy and safety of the 28-day prolonged-release Autogel formulation of the somatostatin analogue lanreotide (Lan-Autogel) in unselected patients with acromegaly.
Summary · context
The study comprised four phases: washout; a double-blind comparison with placebo, at a single randomized dose (60, 90 or 120 mg) of Lan-Autogel; a single-blind, fixed-dose phase for four injections (placebo group was re-allocated to active treatment); and eight injections with doses tailored accordi…
Report a problemFND-1963941503
05HumanNon-randomized trialEfficacy outcome
In acromegaly, 54% had normalized IGF-1 after four lanreotide injections.
In plain wordsIn acromegaly, 54% had normal IGF-1 after four lanreotide injections.
Peptide
Lanreotide
Outcome
Not applicableIGF-1 normalization after four injections
Study
n: not reported in source
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
60, 90 or 120 mg, fixed-dose phaseAs given in this study (human).
Measurements
Patients with normalized IGF-1
54%
after four injections
Source sentences
Summary
After four injections, 72% of patients had a >50% reduction in GH levels; 49% patients achieved GH levels < or = 2.5 ng/ml; 54% had normalized IGF-1; and 38% achieved the combined criterion of GH level < or = 2.5 ng/ml and normalized IGF-1.
2 context sentences(design, population, supporting numbers)
Summary · context
The study was designed to evaluate the long-term efficacy and safety of the 28-day prolonged-release Autogel formulation of the somatostatin analogue lanreotide (Lan-Autogel) in unselected patients with acromegaly.
Summary · context
The study comprised four phases: washout; a double-blind comparison with placebo, at a single randomized dose (60, 90 or 120 mg) of Lan-Autogel; a single-blind, fixed-dose phase for four injections (placebo group was re-allocated to active treatment); and eight injections with doses tailored accordi…
Report a problemFND-1963941504
06HumanNon-randomized trialEfficacy outcome
In acromegaly, 38% met the combined GH and IGF-1 control criterion after four lanreotide injections.
In plain wordsIn acromegaly, 38% achieved combined hormone control after four lanreotide injections.
Peptide
Lanreotide
Outcome
Not applicableCombined biochemical control after four injections
Study
n: not reported in source
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
60, 90 or 120 mg, fixed-dose phaseAs given in this study (human).
Measurements
Patients meeting combined GH <= 2.5 ng/ml and normalized IGF-1 criterion
38%
after four injections
Source sentences
Summary
After four injections, 72% of patients had a >50% reduction in GH levels; 49% patients achieved GH levels < or = 2.5 ng/ml; 54% had normalized IGF-1; and 38% achieved the combined criterion of GH level < or = 2.5 ng/ml and normalized IGF-1.
2 context sentences(design, population, supporting numbers)
Summary · context
The study was designed to evaluate the long-term efficacy and safety of the 28-day prolonged-release Autogel formulation of the somatostatin analogue lanreotide (Lan-Autogel) in unselected patients with acromegaly.
Summary · context
The study comprised four phases: washout; a double-blind comparison with placebo, at a single randomized dose (60, 90 or 120 mg) of Lan-Autogel; a single-blind, fixed-dose phase for four injections (placebo group was re-allocated to active treatment); and eight injections with doses tailored accordi…
Report a problemFND-1963941505
07HumanNon-randomized trialEfficacy outcome
In acromegaly, 82% had a >50% GH reduction by week 52 of lanreotide treatment.
In plain wordsIn acromegaly, 82% had a large growth hormone reduction by week 52 with lanreotide.
Peptide
Lanreotide
Outcome
DecreaseGH reduction greater than half at week 52
Study
n: not reported in source
Comparator
Baseline
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
60, 90 or 120 mg, adjusted according to response · 52 weeksAs given in this study (human).
Measurements
Patients with GH reduction >50%
82%
by week 52
Source sentences
Summary
The corresponding proportions by week 52 were 82, 54, 59 and 43%, respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
After four injections, 72% of patients had a >50% reduction in GH levels; 49% patients achieved GH levels < or = 2.5 ng/ml; 54% had normalized IGF-1; and 38% achieved the combined criterion of GH level < or = 2.5 ng/ml and normalized IGF-1.
Summary · context
The study was designed to evaluate the long-term efficacy and safety of the 28-day prolonged-release Autogel formulation of the somatostatin analogue lanreotide (Lan-Autogel) in unselected patients with acromegaly.
Summary · context
The study comprised four phases: washout; a double-blind comparison with placebo, at a single randomized dose (60, 90 or 120 mg) of Lan-Autogel; a single-blind, fixed-dose phase for four injections (placebo group was re-allocated to active treatment); and eight injections with doses tailored accordi…
Report a problemFND-1963941506
08HumanNon-randomized trialEfficacy outcome
In acromegaly, 54% achieved GH levels at or below 2.5 ng/ml by week 52 with lanreotide.
In plain wordsIn acromegaly, 54% reached the growth hormone threshold by week 52 with lanreotide.
Peptide
Lanreotide
Outcome
Not applicableGH biochemical threshold at week 52
Study
n: not reported in source
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
60, 90 or 120 mg, adjusted according to response · 52 weeksAs given in this study (human).
Measurements
Patients with GH <= 2.5 ng/ml
54%
by week 52
Source sentences
Summary
The corresponding proportions by week 52 were 82, 54, 59 and 43%, respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
After four injections, 72% of patients had a >50% reduction in GH levels; 49% patients achieved GH levels < or = 2.5 ng/ml; 54% had normalized IGF-1; and 38% achieved the combined criterion of GH level < or = 2.5 ng/ml and normalized IGF-1.
Summary · context
The study was designed to evaluate the long-term efficacy and safety of the 28-day prolonged-release Autogel formulation of the somatostatin analogue lanreotide (Lan-Autogel) in unselected patients with acromegaly.
Summary · context
The study comprised four phases: washout; a double-blind comparison with placebo, at a single randomized dose (60, 90 or 120 mg) of Lan-Autogel; a single-blind, fixed-dose phase for four injections (placebo group was re-allocated to active treatment); and eight injections with doses tailored accordi…
Report a problemFND-1963941507
09HumanNon-randomized trialEfficacy outcome
In acromegaly, 59% had normalized IGF-1 by week 52 with lanreotide.
In plain wordsIn acromegaly, 59% had normal IGF-1 by week 52 with lanreotide.
Peptide
Lanreotide
Outcome
Not applicableIGF-1 normalization at week 52
Study
n: not reported in source
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
60, 90 or 120 mg, adjusted according to response · 52 weeksAs given in this study (human).
Measurements
Patients with normalized IGF-1
59%
by week 52
Source sentences
Summary
The corresponding proportions by week 52 were 82, 54, 59 and 43%, respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
After four injections, 72% of patients had a >50% reduction in GH levels; 49% patients achieved GH levels < or = 2.5 ng/ml; 54% had normalized IGF-1; and 38% achieved the combined criterion of GH level < or = 2.5 ng/ml and normalized IGF-1.
Summary · context
The study was designed to evaluate the long-term efficacy and safety of the 28-day prolonged-release Autogel formulation of the somatostatin analogue lanreotide (Lan-Autogel) in unselected patients with acromegaly.
Summary · context
The study comprised four phases: washout; a double-blind comparison with placebo, at a single randomized dose (60, 90 or 120 mg) of Lan-Autogel; a single-blind, fixed-dose phase for four injections (placebo group was re-allocated to active treatment); and eight injections with doses tailored accordi…
Report a problemFND-1963941508
10HumanNon-randomized trialEfficacy outcome
In acromegaly, 43% achieved combined GH and IGF-1 control by week 52 with lanreotide.
In plain wordsIn acromegaly, 43% achieved combined hormone control by week 52 with lanreotide.
Peptide
Lanreotide
Outcome
Not applicableCombined biochemical control at week 52
Study
n: not reported in source
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
60, 90 or 120 mg, adjusted according to response · 52 weeksAs given in this study (human).
Measurements
Patients meeting combined GH <= 2.5 ng/ml and normalized IGF-1 criterion
43%
by week 52
Source sentences
Summary
The corresponding proportions by week 52 were 82, 54, 59 and 43%, respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
After four injections, 72% of patients had a >50% reduction in GH levels; 49% patients achieved GH levels < or = 2.5 ng/ml; 54% had normalized IGF-1; and 38% achieved the combined criterion of GH level < or = 2.5 ng/ml and normalized IGF-1.
Summary · context
The study was designed to evaluate the long-term efficacy and safety of the 28-day prolonged-release Autogel formulation of the somatostatin analogue lanreotide (Lan-Autogel) in unselected patients with acromegaly.
Summary · context
The study comprised four phases: washout; a double-blind comparison with placebo, at a single randomized dose (60, 90 or 120 mg) of Lan-Autogel; a single-blind, fixed-dose phase for four injections (placebo group was re-allocated to active treatment); and eight injections with doses tailored accordi…
Report a problemFND-1963941509
11HumanNon-randomized trialEfficacy outcome
In acromegaly patients without escalation to 120 mg lanreotide, 85% achieved combined biochemical control.
In plain wordsIn acromegaly patients without escalation to 120 mg lanreotide, 85% achieved combined hormone control.
Peptide
Lanreotide
Outcome
Not applicableCombined biochemical control without dose escalation
Study
n: not reported in source
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
60, 90 or 120 mg, adjusted according to responseAs given in this study (human).
Measurements
Patients achieving combined biochemical control
85%
patients not requiring dose escalation to 120 mg
Source sentences
Summary
In patients not requiring dose escalation to 120 mg, 85% achieved biochemical control (combined criterion).
3 context sentences(design, population, supporting numbers)
Summary · context
After four injections, 72% of patients had a >50% reduction in GH levels; 49% patients achieved GH levels < or = 2.5 ng/ml; 54% had normalized IGF-1; and 38% achieved the combined criterion of GH level < or = 2.5 ng/ml and normalized IGF-1.
Summary · context
The study was designed to evaluate the long-term efficacy and safety of the 28-day prolonged-release Autogel formulation of the somatostatin analogue lanreotide (Lan-Autogel) in unselected patients with acromegaly.
Summary · context
The study comprised four phases: washout; a double-blind comparison with placebo, at a single randomized dose (60, 90 or 120 mg) of Lan-Autogel; a single-blind, fixed-dose phase for four injections (placebo group was re-allocated to active treatment); and eight injections with doses tailored accordi…
Report a problemFND-1963941510

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 2/3NCT00234572

Efficacy and Safety Study of Varying Doses of Lanreotide Autogel in Patients With Acromegaly

Ipsenn = 108May 2000 to 3 Jan 2003

Acromegaly

Trial page ClinicalTrials.govUpdated 2 Aug 2019

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, 16:36 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

PepBank is a research reference. Talk to a doctor before you use any peptide.