Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MEDI0382 low dose · 1 trial · 1 indication
To assess the effect of 100, 200, 300 μg of cotadutide on HbA1c versus placebo
To assess the effect of 100, 200, 300 μg of cotadutide on body weight versus placebo
| Arm | Type | Description |
|---|---|---|
| MEDI0382 low dose + Metformin | EXPERIMENTAL | Drug: MEDI0382 low dose Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose) |
| MEDI0382 mid dose + Metformin | EXPERIMENTAL | Drug: MEDI0382 mid dose Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose) |
| MEDI0382 high dose + Metformin | EXPERIMENTAL | Drug: MEDI0382 high dose Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose) |
| Placebo + Metformin | PLACEBO_COMPARATOR | Drug: Placebo Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose) |
| Liraglutide + Metformin | ACTIVE_COMPARATOR | Drug: Liraglutide Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose) |
| Name | Type | Description |
|---|---|---|
| MEDI0382 low dose | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
| MEDI0382 mid dose | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
| MEDI0382 high dose | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
| Placebo | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
| Liraglutide | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
Inclusion Criteria: * Provision of informed consent * Male and female subjects aged ≥ 18 years at screening * Body mass index ≥ 25 kg/m2 at screening * HbA1c range of 7.0% to 10.5% (inclusive) at screening * Diagnosed with type-2 diabetes mellitus (T2DM) and treated with metformin (stable dose of ≥...
MEDI0382 is an investigational small molecule being developed for metabolic conditions, including obesity, type 2 diabetes mellitus, and non-alcoholic fatty liver disease (NAFLD). It has been studied in overweight and obese participants with type 2 diabetes. MEDI0382 is not approved and remains in clinical development.
MEDI0382 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca is conducting clinical trials to evaluate the safety and efficacy of MEDI0382 in metabolic indications.
MEDI0382 is in Phase 2 clinical development. It has completed multiple Phase 2 trials, including studies in overweight and obese participants with type 2 diabetes. MEDI0382 is investigational and has not been approved by regulatory authorities.
MEDI0382 has completed several clinical trials, including NCT02548585, a Phase 1 multiple-ascending-dose study, and NCT03244800, NCT03444584, and NCT03745937, which are Phase 2 studies. These trials evaluated MEDI0382 in overweight and obese participants with type 2 diabetes, including in combination with dapagliflozin and metformin.
MEDI0382 is also referred to as 0382 in some clinical trial titles, such as NCT03244800, which investigates different doses of 0382. Both names refer to the same investigational drug being developed by AstraZeneca for metabolic conditions.