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Acromegaly| IONIS-GHR-LRx Dose 1

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

This is a multi-center, open-label, randomized, Phase 2 study of IONIS-GHR-LRx in up to 40 participants with acromegaly. Participants will be randomized to 1 of 3 treatment groups to receive a single dose of IONIS GHR-LRx monthly for 73 weeks. At the end of 73 weeks, participants will enter a 14-week post-treatment (PT) evaluation period.

IONIS-GHR-LRx Dose 1

Purpose of Study

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

Eligibility

Age:
18 - 75
Sex:
Female Icon + Male Icon

Key Inclusion / Exclusion Criteria

Inclusion Criteria:

  • 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: 4 months
  • pasireotide LAR: 4 months
  • lanreotide (all formulations): 4 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

Exclusion Criteria:

  • Participants who received surgery for pituitary adenoma within the last 6 months before the trial, and/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 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

Conditions:

Acromegaly

Status:

Recruiting

Phase:

Phase 2

Clinical Trials ID

NCT04522180

Read Detailed Summary:

Start Date / End Date:

01 2021 - 08 2023

Intervention:

IONIS-GHR-LRx Dose 1

Enrollment:

40

Full Details:

https://clinicaltrials.gov/ct2/show/NCT04522180