Maintenance of Acromegaly Control in Patients Switching From Injectable Somatostatin Receptor Ligands to Oral Octreotide.

Samson SL, Nachtigall LB, Fleseriu M, Gordon MB, Bolanowski M, Labadzhyan A, Ur E, Molitch M, Ludlam WH, Patou G, Haviv A, Biermasz N and 5 more

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Giustina A, Trainer PJ, Strasburger CJ, Kennedy L, Melmed S

The Journal of clinical endocrinology and metabolism1 Oct 2020Cited by 80 (Europe PMC)

PMID32882036PMCIDPMC7470473DOI10.1210/clinem/dgaa526PepBankPUB-32882036

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Summary

PurposeThe phase 3 CHIASMA OPTIMAL trial (NCT03252353) evaluated efficacy and safety of oral octreotide capsules (OOCs) in patients with acromegaly who previously demonstrated biochemical control while receiving injectable somatostatin receptor ligands (SRLs).MethodsIn this double-blind study, patients (N = 56) stratified by prior SRL dose were randomly assigned 1:1 to OOC or placebo for 36 weeks. The primary end point was maintenance of biochemical control at the end of treatment (mean insulin-like growth factor 1 [IGF-1] ≤ 1.0 × upper limit of normal [ULN]; weeks 34 and 36). Time to loss of IGF-1 response and proportion requiring reversion to injectable SRLs were assessed as broader control measures.ResultsMean IGF-1 measurements were 0.80 and 0.97 × ULN for OOC and 0.84 and 1.69 × ULN for placebo, at baseline and end of treatment, respectively. Mean growth hormone (GH) changed from 0.66 to 0.60 ng/mL for OOCs and 0.90 to 2.57 ng/mL for placebo. Normalization of IGF-1 levels (≤ 1.0 × ULN) was maintained in 58.2% for OOCs vs 19.4% for placebo (P = .008); GH levels were maintained (< 2.5 ng/mL) in 77.7% for OOC vs 30.4% for placebo (P = .0007). Median time to loss of response (IGF-1 > 1.0 or ≥ 1.3 × ULN definitions) for patients receiving placebo was 16 weeks; for patients receiving OOCs, it was not reached for both definitions during the 36-week trial (P < .0001). Of the patients in the OOC group, 75% completed the trial on oral therapy. The OOC safety profile was consistent with previous SRL experience.ConclusionsOOCs may be an effective therapy for patients with acromegaly who previously were treated with injectable SRLs.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

01HumanRandomized controlled trialEfficacy outcome
In patients with acromegaly, oral octreotide maintained normal IGF-1 in 58.2% versus 19.4% with placebo (P = .008).
In plain wordsIn patients with acromegaly, oral octreotide maintained normal IGF-1 more often than placebo.
Peptide
Octreotide
Outcome
IncreaseMaintenance of normal IGF-1
Study
n = 56
Comparator
placebo
Analysis
Primary
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
Dose not stated · oral · 36 weeksAs given in this study (human).
Measurements
Normal IGF-1
58.2%
oral octreotide
Normal IGF-1
19.4%
placebo
Source sentences
Summary
Normalization of IGF-1 levels (≤ 1.0 × ULN) was maintained in 58.2% for OOCs vs 19.4% for placebo (P = .008);
3 context sentences(design, population, supporting numbers)
Summary · context
The primary end point was maintenance of biochemical control at the end of treatment (mean insulin-like growth factor 1 [IGF-1] ≤ 1.0 × upper limit of normal [ULN]; weeks 34 and 36).
Summary · context
The phase 3 CHIASMA OPTIMAL trial (NCT03252353) evaluated efficacy and safety of oral octreotide capsules (OOCs) in patients with acromegaly who previously demonstrated biochemical control while receiving injectable somatostatin receptor ligands (SRLs).
Summary · context
In this double-blind study, patients (N = 56) stratified by prior SRL dose were randomly assigned 1:1 to OOC or placebo for 36 weeks.
Show in the study text Report a problemFND-3288203603
02HumanRandomized controlled trialEfficacy outcome
In patients with acromegaly, oral octreotide maintained GH below 2.5 ng/mL in 77.7% versus 30.4% with placebo (P = .0007).
In plain wordsIn patients with acromegaly, oral octreotide maintained low GH more often than placebo.
Peptide
Octreotide
Outcome
IncreaseMaintenance of GH below threshold
Study
n = 56
Comparator
placebo
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
Dose not stated · oral · 36 weeksAs given in this study (human).
Measurements
GH maintenance
77.7%
oral octreotide
GH maintenance
30.4%
placebo
Source sentences
Summary
GH levels were maintained (< 2.5 ng/mL) in 77.7% for OOC vs 30.4% for placebo (P = .0007).
2 context sentences(design, population, supporting numbers)
Summary · context
The phase 3 CHIASMA OPTIMAL trial (NCT03252353) evaluated efficacy and safety of oral octreotide capsules (OOCs) in patients with acromegaly who previously demonstrated biochemical control while receiving injectable somatostatin receptor ligands (SRLs).
Summary · context
In this double-blind study, patients (N = 56) stratified by prior SRL dose were randomly assigned 1:1 to OOC or placebo for 36 weeks.
Show in the study text Report a problemFND-3288203604
03HumanRandomized controlled trialEfficacy outcome
In patients with acromegaly, median response-loss time was unreached with oral octreotide versus 16 weeks with placebo for both definitions (P < .0001).
In plain wordsIn patients with acromegaly, response loss occurred later with oral octreotide than placebo under both IGF-1 definitions.
Peptide
Octreotide
Outcome
IncreaseTime to loss of IGF-1 response
Study
n = 56
Comparator
placebo
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
Dose not stated · oral · 36 weeksAs given in this study (human).
Measurements
Median time to loss of response
16 weeks
placebo
P
< 0.0001
reported comparison
Source sentences
Summary
Median time to loss of response (IGF-1 > 1.0 or ≥ 1.3 × ULN definitions) for patients receiving placebo was 16 weeks; for patients receiving OOCs, it was not reached for both definitions during the 36-week trial (P < .0001).
2 context sentences(design, population, supporting numbers)
Summary · context
The phase 3 CHIASMA OPTIMAL trial (NCT03252353) evaluated efficacy and safety of oral octreotide capsules (OOCs) in patients with acromegaly who previously demonstrated biochemical control while receiving injectable somatostatin receptor ligands (SRLs).
Summary · context
In this double-blind study, patients (N = 56) stratified by prior SRL dose were randomly assigned 1:1 to OOC or placebo for 36 weeks.
Show in the study text Report a problemFND-3288203605
04HumanNon-randomized trialEfficacy outcome
In patients with controlled acromegaly, mean IGF-1 on oral octreotide changed from 0.80 to 0.97 × ULN.
In plain wordsIn patients with acromegaly, mean IGF-1 on oral octreotide increased from baseline.
Peptide
Octreotide
Outcome
IncreaseMean IGF-1
Study
n: not reported in source
Comparator
baseline
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
Dose not stated · oral · 36 weeksAs given in this study (human).
Measurements
IGF-1
0.8 × ULN
baseline
IGF-1
0.97 × ULN
end of treatment
Source sentences
Summary
Mean IGF-1 measurements were 0.80 and 0.97 × ULN for OOC and 0.84 and 1.69 × ULN for placebo, at baseline and end of treatment, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
The phase 3 CHIASMA OPTIMAL trial (NCT03252353) evaluated efficacy and safety of oral octreotide capsules (OOCs) in patients with acromegaly who previously demonstrated biochemical control while receiving injectable somatostatin receptor ligands (SRLs).
Summary · context
In this double-blind study, patients (N = 56) stratified by prior SRL dose were randomly assigned 1:1 to OOC or placebo for 36 weeks.
Show in the study text Report a problemFND-3288203601
05HumanNon-randomized trialEfficacy outcome
In patients with controlled acromegaly, mean GH on oral octreotide changed from 0.66 to 0.60 ng/mL.
In plain wordsIn patients with acromegaly, mean GH on oral octreotide decreased from baseline.
Peptide
Octreotide
Outcome
DecreaseMean GH
Study
n: not reported in source
Comparator
baseline
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
Dose not stated · oral · 36 weeksAs given in this study (human).
Measurements
GH
0.66 ng/mL
baseline
GH
0.6 ng/mL
end of treatment
Source sentences
Summary
Mean growth hormone (GH) changed from 0.66 to 0.60 ng/mL for OOCs and 0.90 to 2.57 ng/mL for placebo.
2 context sentences(design, population, supporting numbers)
Summary · context
The phase 3 CHIASMA OPTIMAL trial (NCT03252353) evaluated efficacy and safety of oral octreotide capsules (OOCs) in patients with acromegaly who previously demonstrated biochemical control while receiving injectable somatostatin receptor ligands (SRLs).
Summary · context
In this double-blind study, patients (N = 56) stratified by prior SRL dose were randomly assigned 1:1 to OOC or placebo for 36 weeks.
Show in the study text Report a problemFND-3288203602
06HumanNon-randomized trialEfficacy outcome
In patients with acromegaly receiving oral octreotide, 75% completed the trial on oral therapy.
In plain wordsIn patients with acromegaly receiving oral octreotide, 75% completed the trial on oral therapy.
Peptide
Octreotide
Outcome
Not applicableTrial completion on oral therapy
Study
n: not reported in source
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
Dose not stated · oral · 36 weeksAs given in this study (human).
Measurements
Completion
75%
reported result
Source sentences
Summary
Of the patients in the OOC group, 75% completed the trial on oral therapy.
2 context sentences(design, population, supporting numbers)
Summary · context
The phase 3 CHIASMA OPTIMAL trial (NCT03252353) evaluated efficacy and safety of oral octreotide capsules (OOCs) in patients with acromegaly who previously demonstrated biochemical control while receiving injectable somatostatin receptor ligands (SRLs).
Summary · context
In this double-blind study, patients (N = 56) stratified by prior SRL dose were randomly assigned 1:1 to OOC or placebo for 36 weeks.
Show in the study text Report a problemFND-3288203606
07HumanNon-randomized trialSafety outcome
In patients with acromegaly, the oral octreotide safety profile was consistent with previous SRL experience.
In plain wordsIn patients with acromegaly, oral octreotide safety was consistent with previous SRL experience.
Peptide
Octreotide
Outcome
Direction not reportedSafety profile
Study
n: not reported in source
Comparator
previous SRL experience
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · oral · 36 weeksAs given in this study (human).
Source sentences
Summary
The OOC safety profile was consistent with previous SRL experience.
2 context sentences(design, population, supporting numbers)
Summary · context
The phase 3 CHIASMA OPTIMAL trial (NCT03252353) evaluated efficacy and safety of oral octreotide capsules (OOCs) in patients with acromegaly who previously demonstrated biochemical control while receiving injectable somatostatin receptor ligands (SRLs).
Summary · context
In this double-blind study, patients (N = 56) stratified by prior SRL dose were randomly assigned 1:1 to OOC or placebo for 36 weeks.
Show in the study text Report a problemFND-3288203607

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 with posted results · source ClinicalTrials.gov (opens in a new tab)

Status unknownPhase 3Results postedNCT03252353

Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly

Chiasma, Inc.n = 561 Sept 2017 to est. May 2022

Acromegaly

Trial page ClinicalTrials.govUpdated 23 Nov 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, 16:36 UTC
First added · source update from Europe PMC

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

Maintenance of Acromegaly Control in Patients Switching From Injectable Somatostatin Receptor Ligands to Oral Octreotide.

Summary

Results from this study7

Registered trials1

Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly

Version history

Subjects

Publication types

MeSH terms

Keywords