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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05192382 | A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-2) | PHASE3 | ACTIVE NOT_RECRUITING | 111 | — | — | Dec 17, 2021 | Jan 1, 2028 | May 15, 2026 | 57 | United States, Argentina +13 |
| NCT04837040 | A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly | PHASE3 | ACTIVE NOT_RECRUITING | 58 | — | — | May 12, 2021 | Jun 1, 2027 | May 15, 2026 | 39 | United States, Argentina +12 |
| NCT04261712 | A Study to Evaluate the Long-Term Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Advance) | PHASE2 | ACTIVE NOT_RECRUITING | 43 | — | — | Jan 29, 2020 | Mar 1, 2028 | May 15, 2026 | 22 | United States, Brazil +5 |
| NCT03789656 | An Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Edge) | PHASE2 | COMPLETED | 47 | — | — | Mar 12, 2019 | Aug 31, 2020 | Feb 17, 2025 | 26 | United States, Brazil +10 |
| NCT03792555 | A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Evolve) | PHASE2 | COMPLETED | 13 | — | — | Mar 11, 2019 | Aug 12, 2020 | Mar 17, 2025 | 11 | United States, Brazil +6 |
A value \>1.0 indicates IGF-1 levels above the age- and sex-adjusted ULN. Response is defined as an IGF-1 level ≤1.0×ULN based on the average of last 2 measurements.
A value \>1.0 indicates IGF-1 levels above the age- and sex-adjusted ULN. Response is defined as an IGF-1 level ≤1.0×ULN based on the average of last 2 measurements (weeks 34 and 36).
Change from baseline in IGF-1 level at Week 13/End of Treatment (W13/EoT) in Group 1 subjects Efficacy Analysis Set (EAS).
Proportion of subjects who meet responder criteria (based on the mean of two consecutive IGF-1 measurements ≤ upper limit of normal \[ULN\])
| Arm | Type | Description |
|---|---|---|
| Paltusotine | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Paltusotine | DRUG | Paltusotine, tablets, once daily by mouth |
| Placebo | DRUG | Placebo, tablets, once daily by mouth |
Inclusion Criteria: 1. Male and female subjects ≥18 years of age 2. Confirmed diagnosis of acromegaly and either medically naïve, not currently treated, or willing to washout during the study screening period. 3. Females must be non-pregnant and non-lactating, and either surgically sterile, post-me...