| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05546476 | Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15 | PHASE2 | COMPLETED | 187 | — | — | Nov 21, 2022 | Apr 23, 2025 | Jun 3, 2026 | 78 | United States, Australia +9 |
Body weight was measured in kilograms using a calibrated weighing scale. Baseline was defined as the last average of the duplicate measurements prior to, or on Day 1. The average of the duplicate body weights collected at assessment time was considered. The posterior medians and 90 percent (%) credible intervals (5th and 95th percentiles of the relevant posterior distribution) were reported for each randomized dose (including placebo). 4-Parameter maximal effect (E max) model: change from baseline = E 0 + (E max \* dose\^Hill) / (ED 50\^Hill + dose\^Hill), where E0 is the placebo effect, E max is the maximum effect, ED 50 is the dose producing 50% of the maximum effect, and Hill is the slope parameter. Model utilized a Bayesian methodology with a robustified, informative meta-analytic predictive prior for the placebo change from baseline at week 12.
| Arm | Type | Description |
|---|---|---|
| Double-Blind ponsegromab Treatment low dose followed by Open Label ponsegromab Treatment | EXPERIMENTAL | ponsegromab low dose subcutaneous injection every 4 weeks |
| Double-Blind Placebo Treatment followed by Open-Label ponsegromab Treatment | PLACEBO_COMPARATOR | Match placebo subcutaneous injection every 4 weeks |
| Double-Blind ponsegromab Treatment medium dose followed by Open Label ponsegromab Treatment | EXPERIMENTAL | ponsegromab medium dose subcutaneous injection every 4 weeks |
| Double-Blind ponsegromab Treatment high dose followed by Open Label ponsegromab Treatment | EXPERIMENTAL | ponsegromab high dose subcutaneous injection every 4 weeks |
| Name | Type | Description |
|---|---|---|
| ponsegromab | DRUG | Double-Blind ponsegromab Treatment followed by Open Label ponsegromab Treatment |
| Placebo for ponsegromab | DRUG | Double-Blind placebo Treatment followed by Open Label ponsegromab Treatment |
Key Inclusion Criteria: * Documented active diagnosis of non-small cell lung, pancreatic, colorectal cancer * Cachexia defined by Fearon criteria of weight loss * Serum GDF-15 concentrations * Signed informed consent * ECOG PS ≤3 with life expectancy of at least 4 months to be able to complete Part...