Brief Title
Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Patients With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands
Official Title
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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
Efficacy of IONIS GHR-LRx as percent change in serum IGF-1 from Baseline to 28 days after last dose
Secondary Outcome
Proportion of patients achieving normalized IGF-1 levels to within 1.2 times of gender and age limits at 28 days after last dose
Condition
Acromegaly
Intervention
IONIS-GHR-LRx
Study Arms / Comparison Groups
IONIS-GHR-LRx
Description: Single Dose of IONIS GHR-LRx administered subcutaneously once every 28 days for 16 weeks
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
60
Start Date
September 13, 2018
Completion Date
July 2020
Primary Completion Date
July 2020
Eligibility Criteria
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
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
, 800-679-4747, [email protected]
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT03548415
Organization ID
ISIS 766720-CS2
Secondary IDs
2017-004259-22
Responsible Party
Sponsor
Study Sponsor
Ionis Pharmaceuticals, Inc.
Study Sponsor
, ,
Verification Date
June 2020