Recent Updates
Recently added Catalysts

Cotadutide

Phase 1

Type 2 Diabetes | Small molecule | Metabolic |AstraZeneca PLC|Last Updated: Jul 31, 2020

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04208620Safety and Tolerability Study of Cotadutide in Japanese Obese Subjects With Type 2 Diabetes MelitusPHASE1 COMPLETED 16Jan 21, 2020Jul 8, 2020Jul 31, 20203 Japan
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Incidence of treatment-emergent adverse events (TEAEs)
Baseline until the follow-up period, 28 days post-last dose

To assess the safety and tolerability of Cotadutide

Incidence of treatment-emergent serious adverse events (TESAEs)
Baseline until the follow-up period, 28 days post-last dose

To assess the safety and tolerability of Cotadutide

Clinically important changes in 12-lead electrocardiogram (ECG)
Baseline until the follow-up period, 28 days post-last dose

To assess the safety and tolerability of Cotadutide

Vital signs as measured by pulse rate (bpm)
Baseline until the follow-up period, 28 days post-last dose

To assess the safety and tolerability of Cotadutide

Vital signs as measured by blood pressure (mmHg)
Baseline until the follow-up period, 28 days post-last dose

To assess the safety and tolerability of Cotadutide

ABPM (Ambulatory blood pressure monitoring) to measure pulse rate (bpm) and blood pressure (mmHg)
Baseline until the follow-up period, 28 days post-last dose

To assess the safety and tolerability of Cotadutide

Physical examination (abnormality to be reported as part of adverse events)
Baseline until the follow-up period, 28 days post-last dose

To assess the safety and tolerability of Cotadutide

Clinical laboratory evaluations
Baseline until the follow-up period, 28 days post-last dose

To assess the safety and tolerability of Cotadutide

Secondary Endpoints
Area under the concentration-time curve (AUC) during the dosing interval (AUCtau)
Day1 of Up-titration treatment period to Day 21 of Treatment extension period, total of up to 10 weeks
Maximum observed concentration (Cmax)
Day1 of Up-titration treatment period to Day 21 of Treatment extension period, total of up to 10 weeks
Time to Cmax (tmax)
Day1 of Up-titration treatment period to Day 21 of Treatment extension period, total of up to 10 weeks
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORPlacebo administered subcutaneously
CotadutideEXPERIMENTALCotadutide administered subcutaneously
Interventions
NameTypeDescription
PlaceboDRUGPlacebo administered subcutaneously
CotadutideDRUGCotadutide administered subcutaneously
Unlock Study Design Details
Eligibility Criteria
Age Range20 Years — 74 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria 1. Provision of signed and dated written informed consent prior to any mandatory study specific procedures, sampling, and analyses. 2. Subject must be 20 to 74 years of age at screening. 3. HbA1c range of 6.5% to 8.5% at screening and run-in visit. 4. Willing and able to self-inj...

Countries:Japan
Unlock Eligibility Criteria