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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06579105 | Efficacy, Safety, and Tolerability of Once Daily Oral Administration of AZD5004 Versus Placebo for 26 Weeks in Adults With Type 2 Diabetes Mellitus. | PHASE2 | COMPLETED | 406 | — | — | Oct 8, 2024 | Dec 19, 2025 | Jan 13, 2026 | 97 | United States, Canada +7 |
To evaluate the effect of AZD5004 versus placebo on glycemic control
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | Participants will receive xx mg once daily dose of AZD5004 |
| Arm 2 | EXPERIMENTAL | Participants will receive xx mg once daily dose of AZD5004 |
| Arm 3 | EXPERIMENTAL | Participants will receive xx mg once daily dose of AZD5004 |
| Arm 4 | EXPERIMENTAL | Participants will receive xx mg once daily dose of AZD5004 |
| Arm 5 | EXPERIMENTAL | Participants will receive xx mg once daily dose of AZD5004 |
| Arm 6 | EXPERIMENTAL | Participants will receive xx mg once daily dose of AZD5004 |
| Arm 7 | ACTIVE_COMPARATOR | Participants will receive once daily dose of Semaglutide as active comparator |
| Arm 8 | PLACEBO_COMPARATOR | Participants will receive matching placebo for each AZD5004 arm |
| Name | Type | Description |
|---|---|---|
| Placebo (placebo matching AZD5004 film-coated tablet) | DRUG | Placebo film-coated tablet (matching AZD5004) |
| AZD5004 | DRUG | AZD5004 film-coated tablet, once daily during 26 weeks |
| Semaglutide | DRUG | 3-14 mg tablets of Semaglutide |
Inclusion Criteria: Adults ≥ 18 years of age. Diagnosed with T2DM for at least 6 months. HbA1c ≥ 7.0% and ≤ 10.5% managed with diet and exercise alone or with a stable dose of metformin or an SGLT2 inhibitor for at least one month prior to screening. Body mass index of ≥ 23 kg/m2. Stable self-r...