Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD9567 · 3 trials · 2 indications
The change from baseline in glucose AUC(0-4) was analysed to determine the Pharmacodynamic (PD) effect of AZD9567 compared to Prednisolone following a standardised Mixed meal tolerance test (MMTT). In Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0. In Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.
The DAS28-CRP is a measure of disease activity in RA. The score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment (PGA) of health (ranging from very well to very poor). The DAS28-CRP was derived as follows: 0.56 x √\[tender joint count 28 (TJC28)\] + 0.28 x √\[swollen joint count 28 (SJC28)\] + 0.014 x global health (GH) + 0.36 x Ln(CRP+1) + 0.96 to produce the overall DAS28-CRP score on a scale ranged from 0-10 with higher score indicating worse RA symptoms. Baseline was defined as the last non-missing assessment (scheduled or unscheduled) prior to the first dose of study treatment.
Adverse events will be summarized by each dose of AZD9567, pooled prednisolone 20 mg and pooled AZD9567 doses. Tabulations will include causality and severity (mild, moderate and severe), where applicable, and be presented by System Organ Class (SOC) and Preferred Term (PT) where applicable.
Descriptive statistics will be presented by treatment and time point for both observed values and changes from baseline, based on the safety analysis sets. The incidence of clinically notable vital sign abnormalities (vital signs outside the predefined criteria) will be summarized.
Summary tabulations will be presented by treatment including observed values and changes from baseline. Shift tables will be presented to show the shifts from baseline to the minimum and maximum post-baseline measurements, respectively, by treatment, based on the safety analysis set.
Results of the safety ECGs, including normal/abnormal and specific findings will be listed for each subject.
The results of the physical examination will be listed by body system for each subject.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Participants will be randomised in a ratio of 1:1 to receive AZD9567 and prednisolone over two 72 hour periods in a cross over design (72 mg AZD9567 followed by 40 mg prednisolone \[AB sequence group\] or 40 mg prednisolone followed by 72 mg AZD9567 \[BA sequence group\]). |
| Cohort 2 | EXPERIMENTAL | Participants will be randomised in a ratio of 1:1 to receive AZD9567 and prednisolone over two 72 hour periods in a cross over design (40 mg AZD9567 followed by 20 mg prednisolone \[AB sequence group\] or 20 mg prednisolone followed by 40 mg AZD9567 \[BA sequence group\]). |
| Cohort 3 | ACTIVE_COMPARATOR | Participants will be randomised in a ratio of 1:1 to receive placebo and prednisolone over two 72 hour periods in a cross over design (placebo followed by 5 mg prednisolone \[AB sequence group\] or 5 mg prednisolone followed by placebo \[BA sequence group\]). |
| AZD9567 | EXPERIMENTAL | oral suspension of 40 mg AZD9567 once daily (OD) for two weeks |
| Prednisolone | ACTIVE_COMPARATOR | oral OD treatment of 20 mg prednisolone administered as capsules |
| AZD9567 oral suspension of 10 mg | EXPERIMENTAL | Participants will receive oral supension of 10 mg dose strength |
| AZD9567 oral suspension of 20 mg | EXPERIMENTAL | Participants will receive oral suspension of 20 mg dose strength |
| AZD9567 oral suspension of 40 mg | EXPERIMENTAL | Participants will receive oral suspension of 40 mg dose strength |
| AZD9567 oral suspension of 80 mg | EXPERIMENTAL | Participants will receive oral suspension of 80mg dose strength |
| Prednisolone oral capsules of 20 mg | ACTIVE_COMPARATOR | Participants will receive oral capsules of 5 mg dose strength |
| AZD9567 oral suspension of 125 mg | EXPERIMENTAL | Participants will receive oral suspension of 125 mg dose strength |
| AZD9567 oral suspension of 155 mg | EXPERIMENTAL | Participants will receive oral suspension of 155 mg dose strength |
| Prednisolone oral capsules of 5 mg | ACTIVE_COMPARATOR | Participants will receive oral capsules of 5 mg dose strength |
| Prednisolone oral capsules of 40 mg | ACTIVE_COMPARATOR | Participants will receive oral capsules of 5 mg dose strength |
| Name | Type | Description |
|---|---|---|
| AZD9567 | DRUG | Participants will receive 72 mg/day (oral suspension) of AZD9567 for 3 consecutive days of each treatment period in Cohort 1 and 40 mg/day for 3 consecutive days of each treatment period in Cohort 2. |
| Prednisolone | DRUG | Participants will receive 40 mg/day of prednisolone for 3 consecutive days of each treatment period in Cohort 1, 20 mg/day of prednisolone for 3 consecutive days of each treatment period in Cohort 2, and 5 mg/day prednisolone for 3 consecutive days of each treatment period in Cohort 3. |
| Placebo | OTHER | Participants will receive placebo for 3 consecutive days of each treatment period in Cohort 3. |
| AZD9567 10 mg | DRUG | Oral suspension Multiple doses 5 days of treatment Once daily |
| AZD9567 20 mg | DRUG | Oral suspension Multiple doses 5 days of treatment Once daily |
| AZD9567 40 mg | DRUG | Oral suspension Multiple doses 5 days of treatment Once daily |
| AZD9567 80 mg | DRUG | Oral suspension Multiple doses 5 days of treatment Once daily |
| Prednisolone 20 mg | DRUG | Oral Multiple doses 5 days of treatment Once daily |
| AZD9567 125 mg | DRUG | Oral Multiple doses 5 days of treatment Once daily |
| AZD9567 155 mg | DRUG | Oral Multiple doses 5 days of treatment Once daily |
| Prednisolone 5 mg | DRUG | Oral Multiple doses 5 days of treatment Once daily |
| Prednisolone 40 mg | DRUG | Oral Multiple doses 5 days of treatment Once daily |
Inclusion Criteria: * Participants with diagnosis of T2DM for 6 months prior to screening: HbA1c in the diabetes range or fasting plasma glucose 126 -220 mg/dL. * On stable metformin therapy for at least 4 weeks, where no significant dose change (increase or decrease ≥ 500 mg/day) has occurred prio...
AZD9567 is an investigational oral small molecule developed by AstraZeneca PLC (ticker AZN) for metabolic and inflammatory conditions. It has been studied in Phase 2 clinical trials in adults with type 2 diabetes and rheumatoid arthritis. It is not described as an approved medicine and remains in clinical development.
AZD9567 has been studied in type 2 diabetes to assess its effect on glucose homeostasis. A completed Phase 2 trial, NCT04556760, compared two dose levels of AZD9567 with prednisolone in 46 adults with type 2 diabetes in Germany. The drug is investigational and has no approved use.
AstraZeneca PLC, which trades under the ticker AZN, is the developer of AZD9567. The company sponsored the Phase 1 and Phase 2 studies of the compound in rheumatoid arthritis and type 2 diabetes. No other developer or partnership for AZD9567 is identified.
AZD9567 has completed Phase 2 testing. Two Phase 2 trials have been completed: NCT04556760 in type 2 diabetes and NCT03368235 in rheumatoid arthritis. A Phase 1 multiple ascending dose study, NCT02760316, was also completed. AZD9567 is investigational and is not an approved therapy.
AZD9567 has been evaluated in three completed trials. NCT04556760 was a Phase 2 study in type 2 diabetes in Germany. NCT03368235 was a Phase 2 study in rheumatoid arthritis in the Netherlands and Sweden. NCT02760316 was a Phase 1 multiple ascending dose study in Germany and the United Kingdom.