A Study to Assess the Safety, Tolerability, and Efficacy of IONIS-GHR-LRx Administered in Patients With Acromegaly

Completed · Phase 2

Conditions studied: Acromegaly

In brief

The purpose of this study was to determine the safety, tolerability, and efficacy of IONIS-GHR-LRx subcutaneous (SC) injection as monotherapy in patients with acromegaly.

Key facts

Study ID

NCT04522180

Run by

Ionis Pharmaceuticals, Inc.

People needed

34

Starts

2021-01-04

Expected to finish

2023-05-04

Last updated by the study team

2024-10-03

Who can join

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

You may qualify if…

• Males or females with a documented diagnosis of Acromegaly* who are 18 to 75 years old (inclusive) at the time of informed consent.
• Have had pituitary surgery (e.g. transsphenoidal) unless there was a contraindication to surgery and are either acromegaly medical treatment naïve, or who had not taken any other acromegaly medications prior to the screening visit as outlined below
• bromocriptine: 2 weeks
• cabergoline: 4 weeks
• quinagolide: 4 weeks
• octreotide daily injection (SC) or oral formulation: 4 weeks
• pegvisomant: 4 weeks
• octreotide LAR: 3 months
• pasireotide LAR: 4 months
• lanreotide (all formulations): 3 months
• At Screening, serum IGF-1 (performed at the central lab) between 1.3 to 5 × 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 3 months before the trial, and/or planning to receive surgery during the trial
• Participants who received radiotherapy for pituitary adenoma within the last 2 years before the trial, and/or planning to receive radiotherapy during the trial
• Participants with a pituitary tumor that, per Investigator judgment, is worsening (e.g., either growing or at risk of compressing or abutting the optic chiasm or other vital structures) as assessed by pituitary/sellar MRI protocol at Screening or within 3 months of Screening. CT scan is allowed if MRI is contraindicated
• 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
• Symptomatic cholelithiasis, and/or choledocholithiasis

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Palm Research Center Inc. — Las Vegas, Nevada, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Endocrinology Associates, Inc — Columbus, Ohio, United States
• Oregon Health & Science University (OHSU) — Portland, Oregon, United States
• East-Tallinn Central Hospital — Tallinn, Estonia
• Tartu University Hospital — Tartu, Estonia
• Debreceni Egyetem Klinikai Kozpont — Debrecen, Hungary
• Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano — Milan, Italy
• Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore — Roma, Italy
• Pauls Stradins Clinical University Hospital — Riga, Latvia
• Vaidoto Urbanaviciaus Individuali imone — Alytus, Lithuania
• Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos — Kaunas, Lithuania
• Zespol Oddzialow Chorob Wewnetrznych, Endokrynologii i Diabetologii — Warsaw, Poland
• Uniwersytecki Szpital Kliniczny, im. Jana Mikulicza-Radeckiego we Wroclawiu, — Wroclaw, Poland
• Centrum Badan Klinicznych Piotr Napora Lekarze Sp. p. — Wroclaw, Poland
• Centrul Medical Unirea Bucuresti, Endocrinologie — Bucharest, Romania
• I.M. Sechenov Moscow First State Medical University — Moscow, Russia
• Clinical Center of Serbia — Belgrade, Serbia
• Clinical Center of Vojvodina — Novi Sad, Serbia

Full record on ClinicalTrials.gov

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