Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Experimental: Cotadutide · 1 trial · 1 indication
To assess the safety and tolerability of Cotadutide
To assess the safety and tolerability of Cotadutide
Number of participants with abnormal ECGs reported as TEAEs are reported. Abnormal ECGs is defined as any abnormal findings in heart rate, RR interval, PR interval, QRS, QT intervals, and QTcF intervals as measured by digitial 12-lead ECG.
Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal findings in the vital sign parameters (Systolic Blood Pressure, Diastolic Blood Pressure, Pulse, Respiration rate, body temperature).
Number of participants with abnormal physical examinations reported as TEAEs are reported. Abnormal physical examinations findings are defined as any abnormal finding in the following body systems: immunologic/allergy; head, ears, eyes, nose and throat; respiratory; cardiovascular; gastrointestinal; musculoskeletal; neurological psychiatric; dermatologic; hematologic/lymphatic; and enocrine.
To characterize the PK profile of Cotadutide
To characterize the PK profile of Cotadutide
To characterize the PK profile of Cotadutide
To characterize the PK profile of Cotadutide
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of serum chemistry, hematology, and urinalysis.
| Arm | Type | Description |
|---|---|---|
| Cotadutide | EXPERIMENTAL | Those subjects who were randomized to cotadutide once daily SC will begin at 50 μg once daily, then up-titrated to 100 μg once daily a week later, after that up-titration will be done at 100 μg increment weekly, till to a maximum of 600 μg once daily. |
| Placebo | PLACEBO_COMPARATOR | Placebo: Placebo subcutaneous injection |
| Name | Type | Description |
|---|---|---|
| Experimental: Cotadutide | DRUG | Cotadutide: subcutaneous (SC) injection |
| Placebo | OTHER | Placebo subcutaneous injection |
Inclusion Criteria 1. Subjects aged 18 to 74 years 2. Provision of signed and dated written informed consent prior to any study specific procedures 3. BMI between 25 and 35 kg/m2 4. HbA1c range of 7% to 8.5% 5. Willing and able to self-inject investigational product 6. Diagnosed with T2DM with gluc...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| FibroBiologics, Inc. | FBLG | 1 | PHASE1 | Undisclosed |
| MiMedx Group, Inc. | MDXG | 2 | N/A | Undisclosed |
| Integra LifeSciences Holdings Corporation | IART | 1 | N/A | Undisclosed |
| Organogenesis Holdings, Inc. Class A | ORGO | 1 | N/A | Undisclosed |
| Healthcare Services Group, Inc. | HCSG | 1 | N/A | Undisclosed |
Cotadutide is an investigational drug being studied for the treatment of diabetes. It is currently in Phase 1 clinical development. The drug is being developed by AstraZeneca PLC, a biopharmaceutical company. Cotadutide is a small molecule, and it is not yet approved for any use.
Cotadutide 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 the treatment of diabetes. AstraZeneca is conducting research to evaluate the safety and efficacy of cotadutide.
Cotadutide is currently in Phase 1 clinical development. It is an investigational drug being studied for the treatment of diabetes. The drug is not yet approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness. Cotadutide is being developed by AstraZeneca PLC.
Cotadutide has been studied in a Phase 1 clinical trial with the identifier NCT05437848. This trial was a Chinese multiple dose escalation high dose study, which has been completed. The trial enrolled 16 participants with diabetes and was conducted in China. The study was randomized, double-blind, and placebo-controlled.
Cotadutide is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for the treatment of diabetes. The drug is being studied in clinical trials to evaluate its safety and efficacy, but it has not yet received approval from regulatory authorities. Cotadutide is being developed by AstraZeneca PLC.