Trials / Completed
CompletedNCT04522180
A Study to Assess the Safety, Tolerability, and Efficacy of IONIS-GHR-LRx Administered in Patients With Acromegaly
An Open Label, Randomized, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of IONIS-GHR-LRx, an Antisense Inhibitor of the Growth Hormone Receptor, Administered Monthly as Monotherapy in Patients With Acromegaly
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- Ionis Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study was to determine the safety, tolerability, and efficacy of IONIS-GHR-LRx subcutaneous (SC) injection as monotherapy in patients with acromegaly.
Detailed description
This was a multi-center, open-label, randomized, Phase 2 study of IONIS-GHR-LRx in up to 40 participants with acromegaly. Participants were randomized to 1 of 2 treatment groups to receive IONIS GHR-LRx monthly for 73 weeks. At the end of 73 weeks, participants entered a 14-week post-treatment (PT) evaluation period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GHR-LRX | GHR-LRX was administered by SC injection. |
Timeline
- Start date
- 2021-01-04
- Primary completion
- 2022-07-15
- Completion
- 2023-05-04
- First posted
- 2020-08-21
- Last updated
- 2024-10-03
- Results posted
- 2024-10-03
Locations
22 sites across 10 countries: United States, Estonia, Hungary, Italy, Latvia, Lithuania, Poland, Romania, Russia, Serbia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04522180. Inclusion in this directory is not an endorsement.