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Study · Randomized controlled trial · n = 128 · 2020

7 results

Efficacy and safety of lanreotide autogel compared with lanreotide 40 mg prolonged release in Chinese patients with active acromegaly: results from a phase 3, prospective, randomized, and open-label study (LANTERN).

An Z, Lei T, Duan L, Hu P, Gou Z, Zhang L, Durand-Gasselin L, Wang N, Wang Y, Gu F

BMC endocrine disorders4 May 2020Cited by 1 (Europe PMC)

PMID32366244 (opens in a new tab)PMCIDPMC7199333 (opens in a new tab)DOI10.1186/s12902-020-0524-7 (opens in a new tab)PepBankPUB-32366244
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Summary

BackgroundLanreotide autogel is a somatostatin analog (SSA) approved for the treatment of acromegaly in 73 countries worldwide; however, it is not yet approved in China. The aim of this study was to evaluate the efficacy and safety of lanreotide autogel compared with lanreotide 40 mg prolonged release (PR) in Chinese patients with active acromegaly.MethodsLANTERN was a phase 3, randomized, open-label, non-inferiority study. Patients with active acromegaly who had undergone surgery ≥3 months prior, or were unlikely or unable to undergo surgery, were treated with lanreotide autogel 60/90/120 mg (monthly deep subcutaneous injection) or lanreotide 40 mg PR (intramuscular injection every 7, 10, or 14 days) for 32 weeks. Primary endpoint was mean change-from-baseline in age-adjusted insulin-like growth factor-1 (IGF-1) standard deviation scores (SDS) at the end-of-study. Secondary endpoints included: growth hormone (GH) levels ≤2.5 μg/L or ≤ 1.0 μg/L, ≥20% reduction in tumor volume (TV) and safety.ResultsIn total, 128 patients were randomized and received study treatment. Lanreotide autogel was non-inferior to lanreotide 40 mg PR: treatment difference (95% CI) for IGF-1 SDS between groups was - 0.32 (- 0.74, 0.11; per protocol population) and - 0.27 (- 0.63, 0.09; intention-to-treat [ITT] population), respectively. Reductions in IGF-1 (- 6.453 vs - 7.003) and GH levels (- 9.548 μg/L vs - 13.182 μg/L), and the proportion of patients with ≥1 acromegaly symptom (- 20.3% vs - 32.5%) were observed from baseline to end-of-study in lanreotide autogel and lanreotide 40 mg PR groups, respectively. In the lanreotide autogel group, 45.5% (25/55) patients achieved ≥20% reduction in TV compared with 50.9% (25/53) in lanreotide 40 mg PR group (ITT). Safety profiles were similar in both treatment groups.ConclusionsLanreotide autogel was non-inferior to lanreotide 40 mg PR in Chinese patients with active acromegaly after 32 weeks of treatment.Trial registrationRetrospectively registered on ClinicalTrials.gov: NCT02493517 (9 July 2015); prospectively registered on chinadrugtrials.org.cn: CTR20140698 (24 October 2014).
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.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In Chinese patients with acromegaly, lanreotide autogel was noninferior to prolonged-release lanreotide for IGF-1 SDS (ITT difference -0.27, 95% CI -0.63 to 0.09).

    In plain wordsIn Chinese patients with acromegaly, autogel was noninferior to prolonged-release lanreotide for IGF-1 SDS in the ITT analysis.

    Peptide
    Lanreotide
    Outcome
    Not applicableIGF-1 SDS noninferiority, ITT
    Study

    n = 128

    Comparator
    Lanreotide 40 mg prolonged release
    Analysis
    Primary
    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    Autogel 60/90/120 mg monthly · deep subcutaneous injection · 32 weeksAs given in this study (human).

    Measurements

    Treatment difference in IGF-1 SDS
    −0.27 SDS
    autogel versus 40 mg PR, ITT population
    95% CI of treatment difference in IGF-1 SDS
    −0.63 to 0.09 SDS
    ITT population

    Source sentences

    Summary
    Lanreotide autogel was non-inferior to lanreotide 40 mg PR: treatment difference (95% CI) for IGF-1 SDS between groups was - 0.32 (- 0.74, 0.11; per protocol population) and - 0.27 (- 0.63, 0.09; intention-to-treat [ITT] population), respectively.
    2 context sentences
    Summary · context
    LANTERN was a phase 3, randomized, open-label, non-inferiority study.
    Summary · context
    Patients with active acromegaly who had undergone surgery ≥3 months prior, or were unlikely or unable to undergo surgery, were treated with lanreotide autogel 60/90/120 mg (monthly deep subcutaneous injection) or lanreotide 40 mg PR (intramuscular injection every 7, 10, or 14 days) for 32 weeks.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In Chinese patients with acromegaly, lanreotide autogel was noninferior to prolonged-release lanreotide for IGF-1 SDS (per-protocol difference -0.32, 95% CI -0.74 to 0.11).

    In plain wordsIn Chinese patients with acromegaly, autogel was noninferior to prolonged-release lanreotide for IGF-1 SDS in the per-protocol analysis.

    Peptide
    Lanreotide
    Outcome
    Not applicableIGF-1 SDS noninferiority, per protocol
    Study

    n: not reported in source

    Comparator
    Lanreotide 40 mg prolonged release
    Analysis
    Primary
    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    Autogel 60/90/120 mg monthly · deep subcutaneous injection · 32 weeksAs given in this study (human).

    Measurements

    Treatment difference in IGF-1 SDS
    −0.32 SDS
    autogel versus 40 mg PR, per protocol population
    95% CI of treatment difference in IGF-1 SDS
    −0.74 to 0.11 SDS
    per protocol population

    Source sentences

    Summary
    Lanreotide autogel was non-inferior to lanreotide 40 mg PR: treatment difference (95% CI) for IGF-1 SDS between groups was - 0.32 (- 0.74, 0.11; per protocol population) and - 0.27 (- 0.63, 0.09; intention-to-treat [ITT] population), respectively.
    2 context sentences
    Summary · context
    LANTERN was a phase 3, randomized, open-label, non-inferiority study.
    Summary · context
    Patients with active acromegaly who had undergone surgery ≥3 months prior, or were unlikely or unable to undergo surgery, were treated with lanreotide autogel 60/90/120 mg (monthly deep subcutaneous injection) or lanreotide 40 mg PR (intramuscular injection every 7, 10, or 14 days) for 32 weeks.
  3. 03HumanRandomized controlled trialSafety outcome

    In Chinese patients with acromegaly, safety profiles were similar with autogel and prolonged-release lanreotide.

    In plain wordsIn Chinese patients with acromegaly, safety profiles were similar with both lanreotide formulations.

    Peptide
    Lanreotide
    Outcome
    Direction not reportedSafety profile
    Study

    n = 128

    Comparator
    Lanreotide 40 mg prolonged release
    Analysis
    Secondary
    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    Autogel 60/90/120 mg monthly · deep subcutaneous injection · 32 weeksAs given in this study (human).

    Source sentences

    Summary
    Safety profiles were similar in both treatment groups.
    2 context sentences
    Summary · context
    LANTERN was a phase 3, randomized, open-label, non-inferiority study.
    Summary · context
    Patients with active acromegaly who had undergone surgery ≥3 months prior, or were unlikely or unable to undergo surgery, were treated with lanreotide autogel 60/90/120 mg (monthly deep subcutaneous injection) or lanreotide 40 mg PR (intramuscular injection every 7, 10, or 14 days) for 32 weeks.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In Chinese patients with acromegaly, tumor volume response occurred in 45.5% (25/55) with autogel versus 50.9% (25/53) with prolonged-release lanreotide.

    In plain wordsIn Chinese patients with acromegaly, tumor volume response occurred in 45.5% with autogel versus 50.9% with prolonged-release lanreotide.

    Peptide
    Lanreotide
    Outcome
    DecreaseTumor volume reduction at least 20%
    Study

    n = 108

    Comparator
    Lanreotide 40 mg prolonged release
    Analysis
    Secondary
    Outcome group
    Tumor growth · Endocrine and hormones
    Studied dose
    Autogel 60/90/120 mg monthly · deep subcutaneous injection · 32 weeksAs given in this study (human).

    Measurements

    Patients with ≥20% tumor volume reduction
    45.5%
    lanreotide autogel, 25/55 (ITT)
    Patients with ≥20% tumor volume reduction
    50.9%
    lanreotide 40 mg PR, 25/53 (ITT)

    Source sentences

    Summary
    In the lanreotide autogel group, 45.5% (25/55) patients achieved ≥20% reduction in TV compared with 50.9% (25/53) in lanreotide 40 mg PR group (ITT).
    2 context sentences
    Summary · context
    LANTERN was a phase 3, randomized, open-label, non-inferiority study.
    Summary · context
    Patients with active acromegaly who had undergone surgery ≥3 months prior, or were unlikely or unable to undergo surgery, were treated with lanreotide autogel 60/90/120 mg (monthly deep subcutaneous injection) or lanreotide 40 mg PR (intramuscular injection every 7, 10, or 14 days) for 32 weeks.
  5. 05HumanNon-randomized trialEfficacy outcome

    In Chinese patients with acromegaly, IGF-1 decreased from baseline with autogel and prolonged-release lanreotide (-6.453 versus -7.003).

    In plain wordsIn Chinese patients with acromegaly, IGF-1 decreased from baseline with both lanreotide formulations.

    Peptide
    Lanreotide
    Outcome
    DecreaseIGF-1 reduction
    Study

    n: not reported in source

    Comparator
    Baseline in each formulation group
    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    Autogel 60/90/120 mg monthly · deep subcutaneous injection · 32 weeksAs given in this study (human).

    Measurements

    Change in IGF-1 from baseline
    −6.453
    lanreotide autogel
    Change in IGF-1 from baseline
    −7.003
    lanreotide 40 mg PR

    Source sentences

    Summary
    Reductions in IGF-1 (- 6.453 vs - 7.003) and GH levels (- 9.548 μg/L vs - 13.182 μg/L), and the proportion of patients with ≥1 acromegaly symptom (- 20.3% vs - 32.5%) were observed from baseline to end-of-study in lanreotide autogel and lanreotide 40 mg PR groups, respectively.
    2 context sentences
    Summary · context
    LANTERN was a phase 3, randomized, open-label, non-inferiority study.
    Summary · context
    Patients with active acromegaly who had undergone surgery ≥3 months prior, or were unlikely or unable to undergo surgery, were treated with lanreotide autogel 60/90/120 mg (monthly deep subcutaneous injection) or lanreotide 40 mg PR (intramuscular injection every 7, 10, or 14 days) for 32 weeks.
  6. 06HumanNon-randomized trialEfficacy outcome

    In Chinese patients with acromegaly, GH decreased with autogel and prolonged-release lanreotide (-9.548 versus -13.182 μg/L).

    In plain wordsIn Chinese patients with acromegaly, growth hormone decreased from baseline with both lanreotide formulations.

    Peptide
    Lanreotide
    Outcome
    DecreaseGH reduction
    Study

    n: not reported in source

    Comparator
    Baseline in each formulation group
    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    Autogel 60/90/120 mg monthly · deep subcutaneous injection · 32 weeksAs given in this study (human).

    Measurements

    Change in GH from baseline
    −9.548 μg/L
    lanreotide autogel
    Change in GH from baseline
    −13.182 μg/L
    lanreotide 40 mg PR

    Source sentences

    Summary
    Reductions in IGF-1 (- 6.453 vs - 7.003) and GH levels (- 9.548 μg/L vs - 13.182 μg/L), and the proportion of patients with ≥1 acromegaly symptom (- 20.3% vs - 32.5%) were observed from baseline to end-of-study in lanreotide autogel and lanreotide 40 mg PR groups, respectively.
    2 context sentences
    Summary · context
    LANTERN was a phase 3, randomized, open-label, non-inferiority study.
    Summary · context
    Patients with active acromegaly who had undergone surgery ≥3 months prior, or were unlikely or unable to undergo surgery, were treated with lanreotide autogel 60/90/120 mg (monthly deep subcutaneous injection) or lanreotide 40 mg PR (intramuscular injection every 7, 10, or 14 days) for 32 weeks.
  7. 07HumanNon-randomized trialEfficacy outcome

    In Chinese patients with acromegaly, symptom prevalence decreased with autogel and prolonged-release lanreotide (-20.3% versus -32.5%).

    In plain wordsIn Chinese patients with acromegaly, symptom prevalence decreased from baseline with both lanreotide formulations.

    Peptide
    Lanreotide
    Outcome
    DecreasePatients with acromegaly symptoms
    Study

    n: not reported in source

    Comparator
    Baseline in each formulation group
    Outcome group
    Overall treatment effect · Endocrine and hormones
    Studied dose
    Autogel 60/90/120 mg monthly · deep subcutaneous injection · 32 weeksAs given in this study (human).

    Measurements

    Change in proportion of patients with ≥1 acromegaly symptom
    −20.3%
    lanreotide autogel
    Change in proportion of patients with ≥1 acromegaly symptom
    −32.5%
    lanreotide 40 mg PR

    Source sentences

    Summary
    Reductions in IGF-1 (- 6.453 vs - 7.003) and GH levels (- 9.548 μg/L vs - 13.182 μg/L), and the proportion of patients with ≥1 acromegaly symptom (- 20.3% vs - 32.5%) were observed from baseline to end-of-study in lanreotide autogel and lanreotide 40 mg PR groups, respectively.
    2 context sentences
    Summary · context
    LANTERN was a phase 3, randomized, open-label, non-inferiority study.
    Summary · context
    Patients with active acromegaly who had undergone surgery ≥3 months prior, or were unlikely or unable to undergo surgery, were treated with lanreotide autogel 60/90/120 mg (monthly deep subcutaneous injection) or lanreotide 40 mg PR (intramuscular injection every 7, 10, or 14 days) for 32 weeks.

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

CompletedPhase 3Results postedNCT02493517

Efficacy and Safety of Lanreotide Autogel® 60, 90 or 120 mg With Lanreotide 40 mg Prolonged Release (PR) in Acromegaly

Ipsenn = 128Oct 2014 to 16 Feb 2017

Acromegaly

Trial pageClinicalTrials.govUpdated 29 Jan 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.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:36 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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