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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04515849 | A Study of Cotadutide in Participants Who Have Chronic Kidney Disease With Type 2 Diabetes Mellitus | PHASE2 | COMPLETED | 248 | — | — | Aug 31, 2020 | Mar 8, 2022 | Jan 17, 2025 | 83 | Australia, Canada +6 |
Percentage change in UACR of cotadutide at different dose levels compared to placebo after 14 weeks. Efficacy endpoints for cotadutide vs. semaglutide are exploratory and are therefore excluded.
| Arm | Type | Description |
|---|---|---|
| Cotadutide 100 micrograms | EXPERIMENTAL | Cotadutide 100 micrograms administered subcutaneously |
| Cotadutide 300 micrograms | EXPERIMENTAL | Cotadutide 300 micrograms administered subcutaneously |
| Cotadutide 600 micrograms | EXPERIMENTAL | Cotadutide 600 micrograms administered subcutaneously |
| Placebo | PLACEBO_COMPARATOR | Placebo administered subcutaneously |
| Semaglutide | ACTIVE_COMPARATOR | Semaglutide 1.0 miligrams administered subcutaneously |
| Name | Type | Description |
|---|---|---|
| Cotadutide 100 micrograms | DRUG | Cotadutide 100 micrograms administered subcutaneously |
| Cotadutide 300 micrograms | DRUG | Cotadutide 300 micrograms administered subcutaneously |
| Cotadutide 600 micrograms | DRUG | Cotadutide 600 micrograms administered subcutaneously |
| Semaglutide | DRUG | Semaglutide 1.0 miligrams administered subcutaneously |
| Placebo | DRUG | Placebo administered subcutaneously |
Inclusion Criteria: * Estimated glomerular filtration rate ≥ 20 to \< 90 mL/min/1.73 m2 determined at the screening visit or a documented occurrence in medical history at least 3 months prior to randomisation. * Receiving background standard of care treatment for renal disease and/or T2DM and being...