Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands

Completed · Phase 2 · Has a placebo group

Conditions studied: Acromegaly

In brief

The purpose of this study was to assess the safety, tolerability, and efficacy of IONIS-GHR-LRx in up to 60 participants with acromegaly.

Key facts

Study ID

NCT03548415

Run by

Ionis Pharmaceuticals, Inc.

People needed

43

Starts

2018-09-13

Expected to finish

2021-04-02

Last updated by the study team

2022-11-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females with documented diagnosis of acromegaly, aged 18-75 years old (inclusive) at the time of informed consent
• Participants must be on stable maximum or maximally tolerated dose of SRL (Lanreotide Autogel or Octreotide LAR, per treating physician judgment) every 28 days for a minimum of 3 months prior to screening and will be required to continue their stable dose of SRL throughout the study. Prior use of other medications for treating acromegaly is allowed but not within 6 weeks of screening.
• At Screening, serum insulin-like growth factor 1 (IGF-1) (performed at central lab) between 1.3 to 5 x upper limit of normal (ULN), inclusive, adjusted for age and sex
• Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, abstinent, or using 1 highly effective method of birth control

You may not qualify if…

• Participants who received surgery for pituitary adenoma within the last 6 months before the trial, or planning to receive surgery during the trial
• Participants who received radiotherapy for pituitary adenoma within the last 3 years before the trial, and/or planning to receive radiotherapy during the trial
• Participants with pituitary tumor that, per Investigator judgement, is worsening as assessed by pituitary/sellar magnetic resonance imaging (MRI) protocol at Screen or within 6 months of screening
• Evidence of decompensated cardiac function per medical judgement and/or New York Heart Association (NYHA) class 3 or 4
• Clinical evidence of symptomatic hyperprolactinemia that would necessitate treatment
• Participants may not have chronic systemic use of glucocorticoids, weight loss medications or participate in weight loss programs within 2 months before randomization and during study participation.
• Participants on anti-diabetes medication or estrogen containing medications must be on a stable dose and regimen for >= 3 months prior to screening and throughout the trial
• Participants taking glucagon-like peptide 1 (GLP-1) agonists or insulin can be allowed with prior consultation with the Sponsor Medical Monitor

Where it is running

• University of Alabama at Birmingham (UAB) — Birmingham, Alabama, United States
• St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• Northwestern University — Chicago, Illinois, United States
• Palm Research Center, Inc. — Las Vegas, Nevada, United States
• Palm Research Center, Inc. — Las Vegas, Nevada, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Oregon Health & Science University (OHSU) — Portland, Oregon, United States
• Magyar Honvedseg Allami Egeszsegugyi Kozpont, II. sz Belgyogyaszat Osztaly — Budapest, Hungary
• Debreceni Egyetem Klinikai Kozpont — Debrecen, Hungary
• Szeged University - Szent-Gyorgyi Albert Clinical Center - I. Belgyógyászati Klinika (Internal Medicine) — Szeged, Hungary
• Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos - Hospital of Oncology — Kaunas, Lithuania
• Vaidoto Urbanaviciaus Individuali imone - Endokrinologijos klinika — Vilnius, Lithuania
• B_Serwis Popenda Sp. J. Specjalistyczna Przychodnia Lekarsk — Chorzów, Poland
• Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach — Katowice, Poland
• Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o. o. — Krakow, Poland
• Twoja Przychodnia - Centrum Medyczne Nowa Sol — Nowa Sól, Poland
• Mazowiecki Szpital Brodnowski - Zespol Oddzialow Chorob Wewnetrznych, Endokrynologii i Diabetologii — Warsaw, Poland
• Centrum Badan Klinicznych Piotr Napora Lekarze Sp. p. — Wroclaw, Poland
• Centrul Medical Unirea - Bucuresti, Endocrinologie — Bucharest, Romania
• Spitalul Clinic Judetean de Urgenta Cluj - Napoca — Cluj-Napoca, Romania
• Spitalul Clinic Judetean Mures — Târgu Mureş, Romania
• Spitalul Clinic Judetean de Urgenta Timisoara — Timișoara, Romania
• Multi-field Medical Clinic Anturium LLC — Barnaul, Russia
• Interregional Clinical Diagnostic Center — Kazan', Russia
• Kuzbass Clinical Hospital n.a. S.V. Belyaev — Kemerovo, Russia

Full record on ClinicalTrials.gov

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