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cotadutide multidose pen

Phase 1

Type 2 Diabetes Mellitus | Small molecule | Metabolic |AstraZeneca PLC|Last Updated: Apr 7, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

cotadutide multidose pen · 1 trial · 1 indication

Phase 1 1
NCT04091373A Study Investigating the Pharmacokinetics of a Single Dose Administration of CotadutideType 2 Diabetes Mellitus
COMPLETED36 Analytics
PHASE1COMPLETED
A Study Investigating the Pharmacokinetics of a Single Dose Administration of Cotadutide
Type 2 Diabetes MellitusUnlock trial analytics

Study Endpoints

Primary Endpoints

Area under the plasma concentration time curve
48 hours

To evaluate exposure following a single subcutaneous dose of cotadutide at each of 3 different sites of injection.

Secondary Endpoints

Maximum observed plasma drug concentration
48 hours
Area under the plasma concentration time curve from zero to infinity
48 hours
Time to maximum observed plasma drug concentration
48 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Sequence 1EXPERIMENTAL100ug 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 2EXPERIMENTAL100ug 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 3EXPERIMENTAL100ug 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 4EXPERIMENTAL100ug 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 5EXPERIMENTAL100ug 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 6EXPERIMENTAL100ug SC injection cotadutide in the upper arm on Day 1, in the thigh on Day 8, and in the lower abdomen on Day 15

Interventions

NameTypeDescription
cotadutide multidose pen injectionCOMBINATION_PRODUCTSC injection in the upper arm
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:United States
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Frequently asked questions about cotadutide multidose pen

What is cotadutide multidose pen used for?

Cotadutide multidose pen is an investigational small molecule being developed for Type 2 Diabetes Mellitus. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied to evaluate its pharmacokinetics in patients with this condition.

Who makes cotadutide multidose pen?

Cotadutide multidose pen is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetic profile in patients with Type 2 Diabetes Mellitus.

What phase is cotadutide multidose pen in?

Cotadutide multidose pen is in Phase 1 clinical development. It is an investigational drug and has not yet received regulatory approval. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing for Type 2 Diabetes Mellitus.

What clinical trials is cotadutide multidose pen in?

Cotadutide multidose pen has one completed Phase 1 clinical trial registered under NCT04091373. This study investigated the pharmacokinetics of a single dose administration of cotadutide in 36 participants with Type 2 Diabetes Mellitus. The trial was conducted in the United States and included healthy volunteers.

Is cotadutide multidose pen FDA approved?

Cotadutide multidose pen is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Type 2 Diabetes Mellitus. The drug has completed one Phase 1 trial, but it has not yet been evaluated in later-stage trials or submitted for regulatory approval.