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Also known as cotadutide multidose pen injection
cotadutide multidose pen · 1 trial · 1 indication
To evaluate exposure following a single subcutaneous dose of cotadutide at each of 3 different sites of injection.
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | EXPERIMENTAL | 100ug SC injection cotadutide in the upper arm on Day 1, in the lower abdomen on Day 8, and in the thigh on Day 15 |
| Sequence 2 | EXPERIMENTAL | 100ug SC injection cotadutide in the thigh on Day 1, in the upper arm on Day 8, and in the lower abdomen on Day 15 |
| Sequence 3 | EXPERIMENTAL | 100ug SC injection cotadutide in the lower abdomen on Day 1, in the thigh on Day 8, and in the upper arm on Day 15 |
| Sequence 4 | EXPERIMENTAL | 100ug SC injection cotadutide in the thigh on Day 1, in the lower abdomen on Day 8, and in the upper arm on Day 15 |
| Sequence 5 | EXPERIMENTAL | 100ug SC injection cotadutide in the lower abdomen on Day 1, in the upper arm on Day 8, and in the thigh on Day 15 |
| Sequence 6 | EXPERIMENTAL | 100ug SC injection cotadutide in the upper arm on Day 1, in the thigh on Day 8, and in the lower abdomen on Day 15 |
| Name | Type | Description |
|---|---|---|
| cotadutide multidose pen injection | COMBINATION_PRODUCT | SC injection in the upper arm |
Inclusion Criteria: 1. Healthy subjects aged 18 through 60 years (inclusive) at the time of screening. 2. Electronic and/or written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations. 3. BMI between 19 and 30 kg/m2 (inclus...
Cotadutide multidose pen is an injectable, multi-dose pen formulation of cotadutide, an investigational small molecule developed by AstraZeneca PLC for Type 2 Diabetes Mellitus. It is designed to deliver repeated doses from a single pen device. The drug is in Phase 1 clinical development and has not been approved for any indication.
Cotadutide multidose pen is being developed for the treatment of Type 2 Diabetes Mellitus. It is an investigational therapy and is not approved for clinical use. The only completed trial to date enrolled adults with Type 2 Diabetes Mellitus, including healthy volunteers, to evaluate the drug's pharmacokinetics.
Cotadutide multidose pen targets two receptors: the glucagon receptor (GCGR) and the glucagon-like peptide-1 receptor (GLP1R). It acts as an agonist at both targets, meaning it activates these receptors. This dual agonist mechanism is being studied in the context of Type 2 Diabetes Mellitus.
Cotadutide multidose pen is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical program investigating this investigational therapy for Type 2 Diabetes Mellitus.
Cotadutide multidose pen is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any regulatory authority. The Phase 1 program consists of one completed trial, with no active trials currently listed.
Cotadutide multidose pen has been evaluated in one completed Phase 1 trial, NCT04091373, titled "A Study Investigating the Pharmacokinetics of a Single Dose Administration of Cotadutide." The trial enrolled 36 participants in the United States, was randomized and controlled, and included healthy volunteers with Type 2 Diabetes Mellitus.
Yes, cotadutide multidose pen and cotadutide multidose pen injection refer to the same product. The term "injection" describes the route of administration for the multidose pen formulation. Both names identify the investigational AstraZeneca therapy targeting GCGR and GLP1R for Type 2 Diabetes Mellitus.