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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05361668 | Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome | PHASE2 | COMPLETED | 36 | — | — | Apr 22, 2022 | Feb 24, 2026 | Mar 19, 2026 | 35 | United States, Argentina +5 |
Incidence of TEAEs, including serious TEAEs and TEAEs leading to discontinuation; change from baseline to the EOR in safety parameters: clinical laboratory tests, physical exam findings, vital signs, 12-lead ECG, and 24-hour continuous cardiac monitoring (only for subjects on 120 mg dose). In addition to all-cause mortality, deaths were categorized by primary cause (e.g., cardiovascular) based on medical adjudication. Events were coded using MedDRA and summarized by treatment group, system organ class, and preferred term. TEAEs were reported per randomized arm. There were 2 randomized arms (40 mg and 80 mg paltusotine, with up-or down-dose titration permitted for symptom control). Results are analyzed based on the initially assigned randomization arm, regardless of the actual dose received.
| Arm | Type | Description |
|---|---|---|
| 40 mg Paltusotine | EXPERIMENTAL | Participants received paltusotine 40mg, in tablet form, orally, daily, for 8 weeks. |
| 80 mg Paltusotine | EXPERIMENTAL | Participants received paltusotine 80mg, in tablet form, orally, daily for 8 weeks. |
| Name | Type | Description |
|---|---|---|
| Randomized: 40 mg Paltusotine | DRUG | Two 20 mg tablets QD (Potential post-randomization dose escalation based on efficacy and acceptable tolerability: up to 80 mg) |
| Randomized: 80 mg Paltusotine | DRUG | Four 20 mg tablets QD (Potential post-randomization dose escalation based on efficacy and acceptable tolerability: up to 120 mg) |
Inclusion Criteria: 1\. Male or female subjects ≥18 years of age. 2. Documented carcinoid syndrome requiring medical therapy. 1. Not currently treated with somatostatin receptor ligands agonists for at least 12 weeks prior to screening and actively symptomatic. This can include treatment-naïve sub...