Evidence map›Paper›PMID 39378125›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2025

Octreotide Subcutaneous Depot for Acromegaly: A Randomized, Double-blind, Placebo-controlled Phase 3 Trial, ACROINNOVA 1.

Diego Ferone, Pamela Freda, Laurence Katznelson, Federico Gatto, Pinar Kadioğlu, Pietro Maffei, Jochen Seufert, Julie M Silverstein, Joanna L Spencer-Segal, Elena Isaeva and 4 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04076462 (A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04076462 phase3completednot on this map

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients With Acromegaly

TypeinterventionalSponsorCamurus ABRan2019 to 2023Enrolled72ConditionsAcromegalyArmsCAM2029 (octreotide subcutaneous depot), Matching placebo
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Current treatment landscape of acromegaly.The Journal of clinical endocrinology and metabolism · 2026
    Review
  5. What is the future of acromegaly therapy?The Journal of clinical endocrinology and metabolism · 2026
    Review
  6. The acromegaly patient experience: burden of treatment and quality of life.The Journal of clinical endocrinology and metabolism · 2026
    Review
  7. Current controversies in acromegaly care.The Journal of clinical endocrinology and metabolism · 2026
    Review
  8. Review
  9. Review
  10. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Diego FeroneEndocrinology Unit, Department of Internal Medicine, IRCCS Ospedale Policlinico San Martino, 16131 Genova, Italy.ORCID 0000-0002-1410-6143
Pamela FredaDepartment of Medicine, Vagelos College of Physicians & Surgeons, Columbia University, New York, NY 10032, USA.
Laurence KatznelsonDepartments of Medicine and Neurosurgery, Stanford University, Stanford, CA 94305, USA.
Federico GattoEndocrinology Unit, Department of Internal Medicine, IRCCS Ospedale Policlinico San Martino, 16131 Genova, Italy.ORCID 0000-0002-5062-9208
Pinar KadioğluDivision of Endocrinology-Metabolism and Diabetes, Department of Internal Medicine, Istanbul University-Cerrahpasa, 34303 Istanbul, Turkey.
Pietro MaffeiDepartment of Medicine, Padua University Hospital, 35128 Padua, Italy.
Jochen SeufertDivision of Endocrinology and Diabetology, Department of Medicine II, Medical Faculty, University of Freiburg, 79110 Freiburg, Germany.
Julie M SilversteinDivision of Endocrinology, Metabolism and Lipid Research, Washington University School of Medicine, St. Louis, MO 63110, USA.
Joanna L Spencer-SegalDepartment of Internal Medicine and Michigan Neuroscience Institute, University of Michigan, Ann Arbor, MI 48109, USA.
Elena IsaevaInterregional Clinical Diagnostic Center, Kazan 420101, Russia.
Alexander DrevalEndocrinology Department, Moscow Regional Research Clinical Institute, Moscow 117292, Russia.
Maria HarrieCamurus AB, 223 62 Lund, Sweden.
Agneta SvedbergCamurus AB, 223 62 Lund, Sweden.
Fredrik TibergCamurus AB, 223 62 Lund, Sweden.ORCID 0000-0003-0080-4490

Funding

Camurus AB NCT04076462
6 · The paper itself

Abstract

contextAcromegaly, characterized by excessive GH and insulin-like growth factor-1 (IGF-1), impacts quality of life (QoL) and mortality. Standard of care (SoC; octreotide long-acting repeatable or lanreotide autogel) treatment typically requires healthcare provider administration. CAM2029, a novel subcutaneous octreotide depot with increased bioavailability using FluidCrystal technology, enables self-administration and room-temperature storage.

objectiveAssess superiority of CAM2029 vs placebo for biochemical control in patients with controlled acromegaly.

design24-week, multinational, randomized, double-blind, phase 3 trial (NCT04076462).

setting45 sites; 10 countries. PATIENTS: 72 patients on SoC with biochemical control at screening [IGF-1 ≤upper limit of normal (ULN); mean GH <2.5 μg/L].

interventionsPatients were randomized 2:1 to once-monthly CAM2029 (n = 48) or placebo (n = 24).

main outcome measuresThe primary endpoint was proportion of patients with IGF-1 ≤ULN (week 22/24 mean), with dose-reduced patients classified as nonresponders; first key secondary endpoint was the same, including dose-reduced responders. The second key secondary endpoint was proportion of patients with IGF-1 ≤ULN (week 22/24) and mean GH <2.5 μg/L (week 24).

resultsAt week 22/24 (intention-to-treat analysis), CAM2029-treated patients demonstrated superior response rates vs placebo for IGF-1 (72.2% vs 37.5%; risk difference: 34.6, 95% confidence interval: 11.3, 57.9; P = .0018) and combined IGF-1/GH (70.0% vs 37.5%; P = .0035). CAM2029-treated patients had well-controlled symptoms, improved QoL, and treatment satisfaction vs placebo and baseline. CAM2029 was well tolerated; safety was consistent with SoC.

conclusionCAM2029 provides a convenient and effective treatment option for acromegaly, with superior biochemical control vs placebo. Symptom control, QoL, and satisfaction were improved from baseline SoC. CLINICAL

trial registrationNCT04076462 (ClinicalTrials.gov).

Indexed as

AcromegalyOctreotideAdultAgedDelayed-Action PreparationsDouble-Blind MethodFemaleHuman Growth HormoneHumansInjections, SubcutaneousInsulin-Like Growth Factor IMaleMiddle AgedQuality of LifeTreatment OutcomeDelayed-Action PreparationsHuman Growth HormoneIGF1 protein, humanInsulin-Like Growth Factor IOctreotideacromegalyCAM2029FluidCrystaloctreotiderandomized controlled trialsomatostatin receptor ligands

Identifiers

PMID39378125
PMCPMC12086390

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.