Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD4076 · 2 trials · 2 indications
To assess the safety and tolerability of multiple ascending doses of AZD4076
To assess the safety and tolerability of multiple ascending doses of AZD4076
To assess the safety and tolerability of multiple ascending doses of AZD4076
To assess the safety and tolerability of multiple ascending doses of AZD4076
To assess the safety and tolerability of multiple ascending doses of AZD4076
To assess the safety and tolerability of multiple ascending doses of AZD4076
Percentage of patients with abnormal physical examination
Percentage of patients with dermatological adverse events
To assess the safety and tolerability of multiple ascending doses of AZD4076
To assess the safety and tolerability of multiple ascending doses of AZD4076
Percentage of patients with clinically significant changes in laboratory tests.
To assess the safety and tolerability of multiple ascending doses of AZD4076
To assess the effect of AZD4076 on whole body insulin sensitivity using hyperinsulinemic euglycemic clamp with tracer technique
To assess the effect of AZD4076 on liver fat content using magnetic resonance imaging
To assess the safety and tolerability of single doses of AZD4076 by telemetry monitoring and paper printouts
This is a composite of the general appearance, skin, cardiovascular, respiratory, abdomen, head, and neck (including ears, eyes, nose, and throat), lymph nodes, thyroid, musculoskeletal and neurological systems
To assess the safety and tolerability of single doses of AZD4076
| Arm | Type | Description |
|---|---|---|
| Treatment | EXPERIMENTAL | Subjects in this arm will receive AZD4076 |
| Control | PLACEBO_COMPARATOR | Subjects in this arm will receive placebo |
| Cohort 1 | EXPERIMENTAL | Subjects will be fasted for at least 10 hours before dosing and until 4 hours after dosing of a single dose of AZD4076 tetracosasodium or placebo (high doses may be fractionated) |
| Cohort 2 | EXPERIMENTAL | Subjects will be fasted for at least 10 hours before dosing and until 4 hours after dosing of a single dose of AZD4076 tetracosasodium or placebo (high doses may be fractionated) |
| Cohort 3 | EXPERIMENTAL | Subjects will be fasted for at least 10 hours before dosing and until 4 hours after dosing of a single dose of AZD4076 tetracosasodium or placebo (high doses may be fractionated) |
| Cohort 4 | EXPERIMENTAL | Subjects will be fasted for at least 10 hours before dosing and until 4 hours after dosing of a single dose of AZD4076 tetracosasodium or placebo (high doses may be fractionated) |
| Cohort 5 | EXPERIMENTAL | Subjects will be fasted for at least 10 hours before dosing and until 4 hours after dosing of a single dose of AZD4076 tetracosasodium or placebo (high doses may be fractionated) |
| Cohort 6 | EXPERIMENTAL | Subjects will be fasted for at least 10 hours before dosing and until 4 hours after dosing of a single dose of AZD4076 tetracosasodium or placebo (high doses may be fractionated) |
| Name | Type | Description |
|---|---|---|
| AZD4076 | DRUG | Investigational product |
| Placebo | DRUG | Control |
Inclusion criteria 1. Provision of signed and dated, written informed consent prior to any study specific procedures. 2. Males or females of non-child bearing potential. 3. Age 18-70 years with suitable veins for cannulation or repeated venipuncture. 4. BMI 23-40 kg/m2 inclusive. 5. Diagnosed T2D (...
AZD4076 is an investigational small molecule being developed for Non-alcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus with Non-Alcoholic Fatty Liver Disease (T2DM with NAFLD). It is in Phase 1 clinical development and is not yet approved by regulatory authorities.
AZD4076 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The drug is currently in Phase 1 clinical trials for metabolic conditions.
AZD4076 is in Phase 1 clinical development. It has completed two Phase 1 trials, one in healthy male subjects and one in type 2 diabetic subjects with NAFLD. The drug remains investigational and has not received regulatory approval.
AZD4076 has completed two Phase 1 clinical trials. The first, NCT02612662, assessed safety and tolerability of single doses in healthy male subjects with NASH. The second, NCT02826525, studied AZD4076 in type 2 diabetic subjects with NAFLD. Both trials are completed.
AZD4076 is also known by the name AZD-4076. It is a distinct investigational small molecule developed by AstraZeneca for metabolic conditions such as NASH and T2DM with NAFLD. No other alternative names have been reported.