Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04522180 | A Study to Assess the Safety, Tolerability, and Efficacy of IONIS-GHR-LRx Administered in Patients With Acromegaly | PHASE2 | COMPLETED | 34 | — | — | Jan 4, 2021 | May 4, 2023 | Oct 3, 2024 | 22 | United States, Estonia +8 |
IGF-1 is a hormone that manages the effects of growth hormone (GH) in the body. Baseline of IGF-1 is defined as the average value of Screening and Day 1. A negative percent change from Baseline indicated improvement.
| Arm | Type | Description |
|---|---|---|
| GHR-LRX 120 mg | EXPERIMENTAL | Participants received GHR-LRX 120 mg subcutaneous (SC) injection once every month for 73 weeks with a booster dose administered on Day 15 (Week 3). |
| GHR-LRX 160 mg | EXPERIMENTAL | Participants received GHR-LRX 160 mg SC injection once every month for 73 weeks with a booster dose administered on Day 15 (Week 3). |
| Name | Type | Description |
|---|---|---|
| GHR-LRX | DRUG | GHR-LRX was administered by SC injection. |
Inclusion Criteria: 1. Males or females with a documented diagnosis of Acromegaly\* who are 18 to 75 years old (inclusive) at the time of informed consent. 2. Have had pituitary surgery (e.g. transsphenoidal) unless there was a contraindication to surgery and are either acromegaly medical treatment...