Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AZD5004(Part A), [14C]AZD5004 Oral Solution, ECC5004, Active IMP, AZD5004 film-coated tablet
AZD5004 · 5 trials · 6 indications
To determine whether AZD5004 is superior to placebo for weight loss
To determine whether AZD5004 is superior to placebo on achieving weight loss ≥ 5% from baseline
To evaluate the effect of AZD5004 versus placebo on glycemic control
Area under plasma concentration-time curve from zero to infinity
Area under plasma concentration-time curve from time zero to the last measurable concentration
Maximum observed plasma concentration
To assess the safety and tolerability of AZD5004 following single oral doses in healthy participants.
To assess the safety and tolerability of AZD5004 following multiple oral ascending doses in participants with T2DM.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | Active IMP |
| Arm 2 | EXPERIMENTAL | Active IMP |
| Arm 3 | EXPERIMENTAL | Active IMP |
| Arm 4 | EXPERIMENTAL | Active IMP |
| Arm 5 | EXPERIMENTAL | Active IMP |
| Arm 6 | PLACEBO_COMPARATOR | Matching placebo for each of the 5 active arms |
| 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 |
| Group 1 | EXPERIMENTAL | A single oral dose of AZD5004 under fasted conditions. |
| Group 2 | EXPERIMENTAL | A single oral dose of AZD5004 under fasted conditions. |
| Group 3 | EXPERIMENTAL | A single oral dose of AZD5004 under fasted conditions. |
| Group 4 | EXPERIMENTAL | A single oral dose of AZD5004 under fasted conditions. |
| Group 3 (Optional) | EXPERIMENTAL | Participants with moderate renal impairment will receive a single oral dose of AZD5004 under fasted conditions. |
| Part A-AZD5004 | EXPERIMENTAL | Participants will receive AZD5004 orally. |
| Part A-Placebo | PLACEBO_COMPARATOR | Participants will receive matching Placebo orally. |
| Part B-AZD5004 | EXPERIMENTAL | Participants will receive AZD5004 orally. |
| Part B-Placebo | PLACEBO_COMPARATOR | Participants will receive matching Placebo orally. |
| Name | Type | Description |
|---|---|---|
| AZD5004 | DRUG | AZD5004 film-coated tablet once daily during 36 weeks |
| Placebo | DRUG | Placebo matching AZD5004 film-coated tablet once daily during 36 weeks |
| Placebo (placebo matching AZD5004 film-coated tablet) | DRUG | Placebo film-coated tablet (matching AZD5004) |
| Semaglutide | DRUG | 3-14 mg tablets of Semaglutide |
| AZD5004(Part A) | DRUG | Single dose of AZD5004 oral on Day1 |
| Placebo(Part A) | DRUG | Single dose of placebo oral on Day1 |
| AZD5004(Part B) | DRUG | AZD5004 will be administered as an oral tablet once daily. |
| Placebo(Part B) | DRUG | Placebo will be administered as an oral tablet once daily. |
Inclusion Criteria: * Adults ≥ 18 years of age. * BMI of (a) ≥ 30 kg/m2, or (b) ≥ 27 kg/m2 and have a current diagnosis of at least 1 of the following weight-related comorbidities (treated or untreated): (i) Hypertension (ii) Dyslipidemia or hyperlipidemia (iii) CV disease (iv) Obstructive sleep...
AZD5004 is an investigational oral small molecule developed by AstraZeneca PLC for metabolic conditions, including type 2 diabetes, obesity or overweight, and in pharmacokinetic studies of hepatic and renal impairment. It is being studied as a once daily oral treatment and remains in clinical development rather than approved for prescribing.
AZD5004 is being studied for the treatment of type 2 diabetes mellitus, with a Phase 2 trial evaluating once daily oral administration versus placebo over 26 weeks in adults with the condition. It is also being investigated in obesity or overweight and in people with hepatic or renal impairment.
AZD5004 targets the GLP-1 receptor, a cell surface receptor involved in metabolic regulation. It is a small molecule designed to act at this receptor, which distinguishes it from peptide-based GLP-1 therapies that are typically given by injection.
AZD5004 is developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca sponsors the clinical program, including the Phase 2 type 2 diabetes trial and the earlier Phase 1 studies in hepatic impairment, renal impairment, and Japanese participants.
AZD5004 is in Phase 2 development. A Phase 2 trial in adults with type 2 diabetes has been completed, and Phase 1 studies in hepatic impairment, renal impairment, and healthy Japanese participants or participants with type 2 diabetes have also been completed. AZD5004 is investigational and has not been approved by the FDA.
AZD5004 has been studied in completed trials including NCT06579105, a Phase 2 placebo-controlled trial in type 2 diabetes with 406 participants, plus Phase 1 studies NCT06813781 in hepatic impairment, NCT06742762 in renal impairment, and NCT06703658 in healthy Japanese participants and participants with type 2 diabetes.
Yes, AZD5004(Part A) and [14C]AZD5004 Oral Solution are alternative names used for AZD5004 in study documentation. The [14C] label refers to a carbon-14 radiolabeled oral solution formulation used in clinical research, while AZD5004(Part A) denotes a portion of a study.