Purpose

The purpose is to assess the Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in up to 42 Patients with Acromegaly

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Males or females with documented diagnosis of Acromegaly, aged 18-75 years old (inclusive) at the time of informed consent
  2. Patients 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.
  3. At Screening, serum IGF-1 (performed at central lab) between 1.3 to 5 x ULN, inclusive, adjusted for age and sex
  4. 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

  1. Patients who received surgery for pituitary adenoma within the last 6 months before the trial, or planning to receive surgery during the trial
  2. Patients who received radiotherapy for pituitary adenoma within the last 3 years before the trial, and/or planning to receive radiotherapy during the trial
  3. Patients with pituitary tumor that, per Investigator judgement, is worsening as assessed by pituitary/sellar MRI protocol at Screen or within 6 months of screening
  4. Evidence of decompensated cardiac function per medical judgement and/or NYHA class 3 or 4
  5. Clinical evidence of symptomatic hyperprolactinemia that would necessitate treatment
  6. Patients may not have insulin, chronic systemic use of glucocorticoids, weight loss medications or participate in weight loss programs within 2 months before randomization and during study participation.
  7. Patients 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
IONIS-GHR-LRx
Single Dose of IONIS GHR-LRx administered subcutaneously once every 4 weeks for 16 weeks
  • Drug: IONIS-GHR-LRx
    Single Dose of IONIS GHR-LRx administered subcutaneously once every 4 weeks for 16 weeks
Placebo Comparator
Placebo
Placebo (sterile saline 0.9%) Calculated volume to match active comparator administered subcutaneously every 4 weeks for 16 weeks
  • Drug: Placebo
    Placebo (sterile saline 0.9%) Calculated volume to match active comparator administered subcutaneously every 4 weeks for 16 weeks

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114

More Details

NCT ID
NCT03548415
Status
Recruiting
Sponsor
Ionis Pharmaceuticals, Inc.

Study Contact

Ionis Pharmaceuticals
800-679-4747
patients@ionisph.com

Detailed Description

This short-term study will assess changes in serum insulin-like growth factor 1 (IGF-1) over a 16-week treatment period in a patient population diagnosed with Acromegaly being treated with Long-acting Somatostatin Receptor Ligands (SRL)

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.