Pharmacokinetics, pharmacodynamics, and safety of pasireotide LAR in patients with acromegaly: a randomized, multicenter, open-label, phase I study.

Petersenn S, Bollerslev J, Arafat AM, Schopohl J, Serri O, Katznelson L, Lasher J, Hughes G, Hu K, Shen G, Reséndiz KH, Giannone V, Beckers A

Journal of clinical pharmacology24 May 2014Cited by 23 (Europe PMC)

PMID24800725DOI10.1002/jcph.326PepBankPUB-24800725

Publisher page PubMedAsk about this study

Jump to 11 results

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.

01HumanNon-randomized trialPharmacokinetics
In acromegaly, pasireotide LAR reached steady-state concentrations after three monthly injections.
In plain wordsIn acromegaly, pasireotide LAR reached steady blood concentrations after three monthly injections.
Peptide
Pasireotide
Outcome
Not applicableSteady-state concentrations
Study
n = 35
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
20, 40, or 60 mg/monthAs given in this study (human).
Source sentences
Summary
Steady-state pasireotide concentrations were achieved following three monthly injections.
1 context sentence(design, population, supporting numbers)
Summary · context
This randomized, open-label, Phase I study evaluated the safety, PK, and PD of pasireotide LAR 20, 40, or 60 mg/month in patients with acromegaly. Safety assessments and blood samples for PK and PD were taken at designated time points. Thirty-five patients were randomized and completed the study.
Report a problemFND-2480072501
02HumanNon-randomized trialEfficacy outcome
In acromegaly, 51% achieved GH ≤2.5 μg/L at study end with pasireotide LAR.
In plain wordsIn acromegaly, 51% reached growth hormone levels at or below 2.5 μg/L with pasireotide LAR.
Peptide
Pasireotide
Outcome
Not applicableGH control at study end
Study
n = 35
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
20, 40, or 60 mg/monthAs given in this study (human).
Measurements
Patients with GH ≤2.5 μg/L
51%
study end, all dose groups
Source sentences
Summary
At study end, 51% and 57% of patients achieved GH levels ≤2.5 μg/L and IGF-1 levels below ULN, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
This randomized, open-label, Phase I study evaluated the safety, PK, and PD of pasireotide LAR 20, 40, or 60 mg/month in patients with acromegaly. Safety assessments and blood samples for PK and PD were taken at designated time points. Thirty-five patients were randomized and completed the study.
Report a problemFND-2480072505
03HumanNon-randomized trialEfficacy outcome
In acromegaly, 57% achieved IGF-1 below ULN at study end with pasireotide LAR.
In plain wordsIn acromegaly, 57% reached IGF-1 levels below the upper normal limit with pasireotide LAR.
Peptide
Pasireotide
Outcome
Not applicableIGF-1 normalization at study end
Study
n = 35
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
20, 40, or 60 mg/monthAs given in this study (human).
Measurements
Patients with IGF-1 below ULN
57%
study end, all dose groups
Source sentences
Summary
At study end, 51% and 57% of patients achieved GH levels ≤2.5 μg/L and IGF-1 levels below ULN, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
This randomized, open-label, Phase I study evaluated the safety, PK, and PD of pasireotide LAR 20, 40, or 60 mg/month in patients with acromegaly. Safety assessments and blood samples for PK and PD were taken at designated time points. Thirty-five patients were randomized and completed the study.
Report a problemFND-2480072506
04HumanNon-randomized trialSafety outcome
In acromegaly, fasting blood glucose increased from baseline during pasireotide LAR treatment.
In plain wordsIn acromegaly, fasting blood glucose increased from baseline during pasireotide LAR treatment.
Peptide
Pasireotide
Outcome
IncreaseFasting blood glucose
Study
n = 35
Comparator
Baseline
Outcome group
Glycemic control · Endocrine and hormones
Studied dose
20, 40, or 60 mg/monthAs given in this study (human).
Source sentences
Summary
Compared with baseline, fasting blood glucose and HbA1c levels increased, whereas fasting blood insulin levels decreased.
1 context sentence(design, population, supporting numbers)
Summary · context
This randomized, open-label, Phase I study evaluated the safety, PK, and PD of pasireotide LAR 20, 40, or 60 mg/month in patients with acromegaly. Safety assessments and blood samples for PK and PD were taken at designated time points. Thirty-five patients were randomized and completed the study.
Report a problemFND-2480072507
05HumanNon-randomized trialSafety outcome
In acromegaly, HbA1c increased from baseline during pasireotide LAR treatment.
In plain wordsIn acromegaly, HbA1c increased from baseline during pasireotide LAR treatment.
Peptide
Pasireotide
Outcome
IncreaseHbA1c
Study
n = 35
Comparator
Baseline
Outcome group
Glycemic control · Endocrine and hormones
Studied dose
20, 40, or 60 mg/monthAs given in this study (human).
Source sentences
Summary
Compared with baseline, fasting blood glucose and HbA1c levels increased, whereas fasting blood insulin levels decreased.
1 context sentence(design, population, supporting numbers)
Summary · context
This randomized, open-label, Phase I study evaluated the safety, PK, and PD of pasireotide LAR 20, 40, or 60 mg/month in patients with acromegaly. Safety assessments and blood samples for PK and PD were taken at designated time points. Thirty-five patients were randomized and completed the study.
Report a problemFND-2480072508
06HumanNon-randomized trialMechanism
In acromegaly, fasting blood insulin decreased from baseline during pasireotide LAR treatment.
In plain wordsIn acromegaly, fasting blood insulin decreased from baseline during pasireotide LAR treatment.
Peptide
Pasireotide
Outcome
DecreaseFasting blood insulin
Study
n = 35
Comparator
Baseline
Outcome group
Glycemic control · Endocrine and hormones
Studied dose
20, 40, or 60 mg/monthAs given in this study (human).
Source sentences
Summary
Compared with baseline, fasting blood glucose and HbA1c levels increased, whereas fasting blood insulin levels decreased.
1 context sentence(design, population, supporting numbers)
Summary · context
This randomized, open-label, Phase I study evaluated the safety, PK, and PD of pasireotide LAR 20, 40, or 60 mg/month in patients with acromegaly. Safety assessments and blood samples for PK and PD were taken at designated time points. Thirty-five patients were randomized and completed the study.
Report a problemFND-2480072509
07HumanNon-randomized trialEfficacy outcome
In acromegaly, symptoms generally improved during pasireotide LAR treatment.
In plain wordsIn acromegaly, symptoms generally improved during pasireotide LAR treatment.
Peptide
Pasireotide
Outcome
Direction not reportedAcromegaly symptoms
Study
n = 35
Outcome group
Disease Signs And Symptoms · Endocrine and hormones
Studied dose
20, 40, or 60 mg/monthAs given in this study (human).
Source sentences
Summary
Acromegaly symptoms were generally improved.
1 context sentence(design, population, supporting numbers)
Summary · context
This randomized, open-label, Phase I study evaluated the safety, PK, and PD of pasireotide LAR 20, 40, or 60 mg/month in patients with acromegaly. Safety assessments and blood samples for PK and PD were taken at designated time points. Thirty-five patients were randomized and completed the study.
Report a problemFND-2480072510
08HumanNon-randomized trialSafety outcome
In acromegaly, adverse events with pasireotide LAR were mostly gastrointestinal and mild/moderate.
In plain wordsIn acromegaly, adverse events with pasireotide LAR were mostly digestive and mild or moderate.
Peptide
Pasireotide
Outcome
Not applicableAdverse events, mostly gastrointestinal and mild/moderate
Study
n = 35
Outcome group
Adverse events · Whole body
Studied dose
20, 40, or 60 mg/monthAs given in this study (human).
Source sentences
Summary
Adverse events were mostly gastrointestinal and mild/moderate.
1 context sentence(design, population, supporting numbers)
Summary · context
This randomized, open-label, Phase I study evaluated the safety, PK, and PD of pasireotide LAR 20, 40, or 60 mg/month in patients with acromegaly. Safety assessments and blood samples for PK and PD were taken at designated time points. Thirty-five patients were randomized and completed the study.
Report a problemFND-2480072511
09HumanNon-randomized trialPharmacokinetics
In acromegaly, trough pasireotide concentrations 28 days after each 20 mg injection were 2.48, 4.16 and 3.10 ng/mL.
In plain wordsIn acromegaly, pasireotide trough concentrations after 20 mg injections were 2.48, 4.16 and 3.10 ng/mL.
Peptide
Pasireotide
Outcome
Not applicableTrough concentrations, 20 mg
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
20 mg/monthAs given in this study (human).
Measurements
Trough pasireotide concentration
2.48 ng/mL
20 mg group, 28 days after injection 1
Trough pasireotide concentration
4.16 ng/mL
20 mg group, 28 days after injection 2
Trough pasireotide concentration
3.1 ng/mL
20 mg group, 28 days after injection 3
Source sentences
Summary
Trough pasireotide concentrations (ng/mL) 28 days after each injection were: 2.48, 4.16, and 3.10 (20 mg group); 6.42, 6.62, and 7.12 (40 mg group); and 9.51, 11.7, and 13.0 (60 mg group).
1 context sentence(design, population, supporting numbers)
Summary · context
This randomized, open-label, Phase I study evaluated the safety, PK, and PD of pasireotide LAR 20, 40, or 60 mg/month in patients with acromegaly. Safety assessments and blood samples for PK and PD were taken at designated time points. Thirty-five patients were randomized and completed the study.
Report a problemFND-2480072502
10HumanNon-randomized trialPharmacokinetics
In acromegaly, trough pasireotide concentrations 28 days after each 40 mg injection were 6.42, 6.62 and 7.12 ng/mL.
In plain wordsIn acromegaly, pasireotide trough concentrations after 40 mg injections were 6.42, 6.62 and 7.12 ng/mL.
Peptide
Pasireotide
Outcome
Not applicableTrough concentrations, 40 mg
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
40 mg/monthAs given in this study (human).
Measurements
Trough pasireotide concentration
6.42 ng/mL
40 mg group, 28 days after injection 1
Trough pasireotide concentration
6.62 ng/mL
40 mg group, 28 days after injection 2
Trough pasireotide concentration
7.12 ng/mL
40 mg group, 28 days after injection 3
Source sentences
Summary
Trough pasireotide concentrations (ng/mL) 28 days after each injection were: 2.48, 4.16, and 3.10 (20 mg group); 6.42, 6.62, and 7.12 (40 mg group); and 9.51, 11.7, and 13.0 (60 mg group).
1 context sentence(design, population, supporting numbers)
Summary · context
This randomized, open-label, Phase I study evaluated the safety, PK, and PD of pasireotide LAR 20, 40, or 60 mg/month in patients with acromegaly. Safety assessments and blood samples for PK and PD were taken at designated time points. Thirty-five patients were randomized and completed the study.
Report a problemFND-2480072503
11HumanNon-randomized trialPharmacokinetics
In acromegaly, trough pasireotide concentrations 28 days after each 60 mg injection were 9.51, 11.7 and 13.0 ng/mL.
In plain wordsIn acromegaly, pasireotide trough concentrations after 60 mg injections were 9.51, 11.7 and 13.0 ng/mL.
Peptide
Pasireotide
Outcome
Not applicableTrough concentrations, 60 mg
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
60 mg/monthAs given in this study (human).
Measurements
Trough pasireotide concentration
9.51 ng/mL
60 mg group, 28 days after injection 1
Trough pasireotide concentration
11.7 ng/mL
60 mg group, 28 days after injection 2
Trough pasireotide concentration
13 ng/mL
60 mg group, 28 days after injection 3
Source sentences
Summary
Trough pasireotide concentrations (ng/mL) 28 days after each injection were: 2.48, 4.16, and 3.10 (20 mg group); 6.42, 6.62, and 7.12 (40 mg group); and 9.51, 11.7, and 13.0 (60 mg group).
1 context sentence(design, population, supporting numbers)
Summary · context
This randomized, open-label, Phase I study evaluated the safety, PK, and PD of pasireotide LAR 20, 40, or 60 mg/month in patients with acromegaly. Safety assessments and blood samples for PK and PD were taken at designated time points. Thirty-five patients were randomized and completed the study.
Report a problemFND-2480072504

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 1NCT00446082

Study of Pasireotide Long Acting Release (LAR) Injection in Patients With Acromegaly and Patients With Carcinoid Disease

Novartis Pharmaceuticalsn = 85Jun 2006 to Nov 2013

Carcinoid Tumor · Acromegaly

Trial page ClinicalTrials.govUpdated 21 Dec 2020

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.

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