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

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ClinicalTrials.gov Identifier: NCT03548415
Recruitment Status : Completed
First Posted : June 7, 2018
Last Update Posted : May 18, 2021
Sponsor:
Information provided by (Responsible Party):
Ionis Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE May 22, 2018
First Posted Date  ICMJE June 7, 2018
Last Update Posted Date May 18, 2021
Actual Study Start Date  ICMJE September 13, 2018
Actual Primary Completion Date April 2, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2018)
  • Efficacy of IONIS GHR-LRx as percent change in serum IGF-1 from Baseline to 28 days after last dose [ Time Frame: Baseline and 28 days after the last dose ]
  • Incidence and severity of adverse events that are related to treatment with IONIS GHR-LRx. [ Time Frame: Up to 211 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2018)
  • Proportion of patients achieving normalized IGF-1 levels to within 1.2 times of gender and age limits at 28 days after last dose [ Time Frame: 28 days after the last dose ]
  • Proportion of patients achieving normalized IGF-1 levels to within 1.0 times of gender and age limits at 28 days after last dose [ Time Frame: 28 days after the last dose ]
  • Change from Baseline in serum IGF-1 over time [ Time Frame: Up to 31 weeks ]
  • Percent change from Baseline in Serum IGF-1 over time [ Time Frame: Up to 31 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Patients With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands
Official Title  ICMJE A Double-Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of ISIS 766720 (IONIS-GHR-LRx, an Antisense Inhibitor of the Growth Hormone Receptor) Administered Once Every 28 Days for 16 Weeks in Patients With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands (SRL)
Brief Summary The purpose is to assess the Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in up to 60 Patients with Acromegaly
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)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acromegaly
Intervention  ICMJE
  • Drug: IONIS-GHR-LRx
    Single Dose of IONIS GHR-LRx administered subcutaneously once every 28 days for 16 weeks
  • Drug: Placebo
    Placebo (sterile saline 0.9%) Calculated volume to match active comparator administered subcutaneously every 28 days for 16 weeks
Study Arms  ICMJE
  • Experimental: IONIS-GHR-LRx
    Single Dose of IONIS GHR-LRx administered subcutaneously once every 28 days for 16 weeks
    Intervention: Drug: IONIS-GHR-LRx
  • Placebo Comparator: Placebo
    Placebo (sterile saline 0.9%) Calculated volume to match active comparator administered subcutaneously every 28 days for 16 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 17, 2020)
43
Original Estimated Enrollment  ICMJE
 (submitted: June 5, 2018)
42
Actual Study Completion Date  ICMJE April 2, 2021
Actual Primary Completion Date April 2, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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
  8. Patients taking GLP-1 agonists or insulin can be allowed with prior consultation with the Sponsor Medical Monitor
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Czechia,   Hungary,   Lithuania,   Poland,   Romania,   Russian Federation,   Serbia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03548415
Other Study ID Numbers  ICMJE ISIS 766720-CS2
2017-004259-22 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ionis Pharmaceuticals, Inc.
Study Sponsor  ICMJE Ionis Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ionis Pharmaceuticals, Inc.
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP