Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands
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ClinicalTrials.gov Identifier: NCT03967249 |
Recruitment Status :
Completed
First Posted : May 30, 2019
Last Update Posted : August 8, 2022
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Condition or disease | Intervention/treatment | Phase |
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Acromegaly | Drug: IONIS GHR-LRx Drug: SRL | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 39 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-Label Extension Trial of IONIS GHR-LRx, an Antisense Inhibitor of the Growth Hormone Receptor Administered Monthly Subcutaneously to Patients With Acromegaly Being Treated With Long-Acting Somatostatin Receptor Ligands (SRL) |
Actual Study Start Date : | July 25, 2019 |
Actual Primary Completion Date : | March 31, 2022 |
Actual Study Completion Date : | July 7, 2022 |

Arm | Intervention/treatment |
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Experimental: IONIS GHR-LRx + SRL
IONIS GHR-LRx (as per dose in previous study) will be administered subcutaneously once every 28 days for 53 weeks.
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Drug: IONIS GHR-LRx
IONIS GHR-LRx subcutaneous injection Drug: SRL Participants will receive SRL once monthly |
- The Incidence of Adverse Events [ Time Frame: Up to approximately 16 months ]Incidence of adverse events (AEs), serious AEs, treatment related AEs, AEs leading to withdrawal
- Percent Change from Baselines in Insulin-like Growth Factor I (IGF-1) Levels [ Time Frame: Baseline and at Week 26 and Week 53 ]
- Percentage of Participants who Achieve Normalized IGF-1 Levels to Within 1.2 Times of Gender and Age-Adjusted Upper Limits [ Time Frame: Week 26 and at 28 days after the Week 53 dose ]
- Percentage of Participants who Achieve Normalized IGF-1 Levels to Within 1.0 Times of Gender and Age-Adjusted Upper Limits [ Time Frame: Week 26 and at 28 days after the Week 53 dose ]
- Percentage of Participants who Begin Other Acromegaly Medication [ Time Frame: Up to approximately 16 months ]
- Time From First Dose of IONIS GHR-LRx in this open label extension (CS3) to Date of Initiation of Other Acromegaly Medications [ Time Frame: Up to approximately 16 months ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Randomized in index trial (CS2) and completed the entire study, or completion of the treatment period for CS2 and completed or plan to complete PTWK5 visit with an acceptable safety profile, per investigator judgment
- Participants with confirmed stable monthly regimen of SRL for 3 months prior to screening
- Able and willing to participate in a 53-week treatment and 14-week post-treatment study
Exclusion Criteria:
- Treatment with any other acromegaly medications taken prior to Day 1 within the time period: bromocriptine: 2 weeks, carbergoline: 4 weeks, quinagolide: 4 weeks, pegvisomant: 4 weeks and pasireotide: 4 months
- Participant who received surgery for pituitary adenoma in the last 3 months prior to screening and participants needing and/or planning to receive surgery for the pituitary adenoma during the trial
- Unwilling to comply with required study procedures during the treatment and post-treatment periods

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03967249

Responsible Party: | Ionis Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT03967249 |
Other Study ID Numbers: |
ISIS 766720-CS3 2019-000591-42 ( EudraCT Number ) |
First Posted: | May 30, 2019 Key Record Dates |
Last Update Posted: | August 8, 2022 |
Last Verified: | August 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Acromegaly, IONIS-GHR-LRx |
Acromegaly Bone Diseases, Endocrine Bone Diseases Musculoskeletal Diseases Hyperpituitarism Pituitary Diseases |
Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Endocrine System Diseases |