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Experimental: Cotadutide

Phase 1

Diabetes | Small molecule | Metabolic |AstraZeneca PLC|Last Updated: Nov 7, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05437848Chinese Multiple Dose Escalation (MDE) High Dose StudyPHASE1 COMPLETED 16 — — Feb 25, 2022Dec 12, 2022Nov 7, 20232 China
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Study Endpoints
Primary Endpoints
Incidence of treatment-emergent adverse events (TEAEs)
Baseline until the follow-up period (28 days post last dose), 98 days in total

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), 98 days in total

To assess the safety and tolerability of Cotadutide

Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs
Baseline until the follow-up period (28 days post last dose), 98 days in total

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
Baseline until the follow-up period (28 days post last dose), 98 days in total

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
Baseline until the follow-up period (28 days post last dose), 98 days in total

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.

Area under the concentration-time curve (AUC) during the dosing interval (AUCtau)
Day 1 of Up-titration treatment period through 3 days post lost dose, total of up to 73 days.

To characterize the PK profile of Cotadutide

Maximum observed concentration (Cmax)
Day 1 of Up-titration treatment period through 3 days post lost dose, total of up to 73 days.

To characterize the PK profile of Cotadutide

Time to Cmax (tmax)
Day 1 of Up-titration treatment period through 3 days post lost dose, total of up to 73 days.

To characterize the PK profile of Cotadutide

Trough plasma concentration (Ctrough)
Day 1 of Up-titration treatment period through 3 days post lost dose, total of up to 73 days.

To characterize the PK profile of Cotadutide

Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs
Baseline until the follow-up period (28 days post last dose), 98 days in total

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.

Secondary Endpoints
Anti-drug antibodies (ADAs) to Cotadutide
Day 1 of Up-titration treatment period through end of study, 98 days in total
Change in daily average glucose levels
baseline to the end of extension period, and during 14 days of the follow up period, 84 days in total.
Change in 7-day average glucose levels
Baseline (Days -7 to -1), Days 1-7, Days 8-14, Days 15-21, Days 22-28, Days 29-35, Days 36-42, Days 43-49 of the up-titration period, Days 50-56, Days 57-63, Days 64 - 70 of the treatment extension period
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CotadutideEXPERIMENTALThose 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.
PlaceboPLACEBO_COMPARATORPlacebo: Placebo subcutaneous injection
Interventions
NameTypeDescription
Experimental: CotadutideDRUGCotadutide: subcutaneous (SC) injection
PlaceboOTHERPlacebo subcutaneous injection
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Eligibility Criteria
Age Range18 Years — 74 Years
SexALL
Healthy VolunteersNo
Study Sites2

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...

Countries:China
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Competitive Landscape -Diabetes Complications 6 trials
CompanyTickerTrialsLead PhaseDrugs
FibroBiologics, Inc.FBLG1PHASE1Undisclosed
MiMedx Group, Inc.MDXG2NAUndisclosed
Integra LifeSciences Holdings CorporationIART1NAUndisclosed
Organogenesis Holdings, Inc. Class AORGO1NAUndisclosed
Healthcare Services Group, Inc.HCSG1NAUndisclosed
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