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Cotadutide 100 micrograms

Phase 2

Type 2 Diabetes Mellitus | Small molecule | Metabolic |AstraZeneca PLC|Last Updated: Jan 17, 2025

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment248

FDA Designations

No designations recorded

Clinical trial landscape

Cotadutide 100 micrograms · 1 trial · 2 indications

Phase 2 1
NCT04515849A Study of Cotadutide in Participants Who Have Chronic Kidney Disease With Type 2 Diabetes MellitusType 2 Diabetes Mellitus
COMPLETED248 Analytics
PHASE2COMPLETED
A Study of Cotadutide in Participants Who Have Chronic Kidney Disease With Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus
NCT04515849248
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Study Endpoints

Primary Endpoints

The Primary Endpoint Was Percentage Change in UACR of Cotadutide at Different Dose Levels Compared to Placebo After 14 Weeks
Baseline to the end of 14 weeks of dosing

Percentage change in UACR of cotadutide at different dose levels compared to placebo after 14 weeks. Efficacy endpoints for cotadutide vs. semaglutide are exploratory and are therefore excluded.

Secondary Endpoints

Percentage Change in UACR of Cotadutide at Different Dose Levels Compared to Placebo After 26 Weeks
Baseline to end of 26 weeks of dosing
Percent Change in Body Weight of Cotatudide at Different Dose Levels Versus Placebo From Baseline to End of 14 Weeks of Dosing
Baseline to end of 14 weeks of dosing
Percentage Change in Body Weight of Cotadutide at Different Dose Levels Versus Placebo From Baseline to End of 26 Weeks of Dosing
Baseline to end of 26 weeks of dosing
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cotadutide 100 microgramsEXPERIMENTALCotadutide 100 micrograms administered subcutaneously
Cotadutide 300 microgramsEXPERIMENTALCotadutide 300 micrograms administered subcutaneously
Cotadutide 600 microgramsEXPERIMENTALCotadutide 600 micrograms administered subcutaneously
PlaceboPLACEBO_COMPARATORPlacebo administered subcutaneously
SemaglutideACTIVE_COMPARATORSemaglutide 1.0 miligrams administered subcutaneously

Interventions

NameTypeDescription
Cotadutide 100 microgramsDRUGCotadutide 100 micrograms administered subcutaneously
Cotadutide 300 microgramsDRUGCotadutide 300 micrograms administered subcutaneously
Cotadutide 600 microgramsDRUGCotadutide 600 micrograms administered subcutaneously
SemaglutideDRUGSemaglutide 1.0 miligrams administered subcutaneously
PlaceboDRUGPlacebo administered subcutaneously
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Eligibility Criteria

Age Range18 Years to 79 Years
SexALL
Healthy VolunteersNo
Study Sites83

Inclusion Criteria: * Estimated glomerular filtration rate ≥ 20 to \< 90 mL/min/1.73 m2 determined at the screening visit or a documented occurrence in medical history at least 3 months prior to randomisation. * Receiving background standard of care treatment for renal disease and/or T2DM and being...

Countries:AustraliaCanadaGermanyJapanNew ZealandPolandSpainUnited Kingdom
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Frequently asked questions about Cotadutide 100 micrograms

What is Cotadutide 100 micrograms used for?

Cotadutide 100 micrograms is an investigational small molecule being studied for the treatment of Type 2 Diabetes Mellitus, specifically in patients who also have chronic kidney disease. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes Cotadutide 100 micrograms?

Cotadutide 100 micrograms is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Type 2 Diabetes Mellitus and chronic kidney disease.

What phase is Cotadutide 100 micrograms in?

Cotadutide 100 micrograms is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved for commercial use. The Phase 2 trial has been completed, and the drug is being evaluated for its potential to treat Type 2 Diabetes Mellitus in patients with chronic kidney disease.

What clinical trials is Cotadutide 100 micrograms in?

Cotadutide 100 micrograms has been studied in one completed Phase 2 clinical trial with the identifier NCT04515849. This randomized, double-blind, placebo-controlled trial enrolled 248 participants with Type 2 Diabetes Mellitus and chronic kidney disease. The study was conducted across multiple countries, including Australia, Canada, Germany, Japan, New Zealand, Poland, Spain, and the United Kingdom.

Is Cotadutide 100 micrograms the same as Cotadutide?

Cotadutide 100 micrograms is a specific dosage strength of the drug Cotadutide. The clinical trial NCT04515849 evaluated this dosage in participants with Type 2 Diabetes Mellitus and chronic kidney disease. The drug is being developed by AstraZeneca PLC and is currently in Phase 2 clinical development.