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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1245-5276 | Other Identifier | WHO | |
| 2019-002193-31 | EudraCT Number | ||
| 2024-511921-75-00 | EU Trial (CTIS) Number |
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A phase 2, open label, long-term extension study designed to evaluate the safety and efficacy of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with acromegaly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paltusotine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paltusotine | Drug | Paltusotine, once daily by mouth |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) throughout the study | Week 316 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in insulin-like growth factor-1 (IGF-1) level | Week 16, Week 312 | |
| Change in growth hormone (GH) level | Week 16, Week 312 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Crinetics Study Site | Los Angeles | California | 90095 | United States | ||
| Crinetics Study Site |
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| Chicago |
| Illinois |
| 60611 |
| United States |
| Crinetics Study Site | Boston | Massachusetts | 02114 | United States |
| Crinetics Study Site | Columbus | Ohio | 43210 | United States |
| Crinetics Study Site | Pittsburgh | Pennsylvania | 15212 | United States |
| Crinetics Study Site | Pittsburgh | Pennsylvania | 15213 | United States |
| Crinetics Study Site | Dallas | Texas | 75231 | United States |
| Crinetics Study Site | Curitiba | Paraná | 80030-110 | Brazil |
| Crinetics Study Site | Rio de Janeiro | 20231 | Brazil |
| Crinetics Study Site | Rio de Janeiro | 21941 | Brazil |
| Crinetics Study Site | São Paulo | 01228 | Brazil |
| Crinetics Study Site | München | 80336 | Germany |
| Crinetics Study Site | Athens | 10676 | Greece |
| Crinetics Study Site 1 | Athens | 11527 | Greece |
| Crinetics Study Site 2 | Athens | 11527 | Greece |
| Crinetics Study Site | Thessaloniki | 54642 | Greece |
| Crinetics Study Site | Budapest | 1062 | Hungary |
| Crinetics Study Site | Budapest | 1083 | Hungary |
| Crinetics Study Site | Pécs | 7624 | Hungary |
| Crinetics Study Site | Belgrade | 11000 | Serbia |
| Crinetics Study Site | Coventry | United Kingdom |
| Crinetics Study Site | Leeds | LS97TF | United Kingdom |
| ID | Term |
|---|---|
| D000172 | Acromegaly |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
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