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Cotadutide

Phase 2

Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis | Small molecule | Gastrointestinal |AstraZeneca PLC|Last Updated: Sep 3, 2025

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment54

FDA Designations

No designations recorded

Clinical trial landscape

Cotadutide · 3 trials · 5 indications

Phase 2 1Phase 1 2
NCT05364931A Study to Evaluate the Safety and Efficacy of Cotadutide Given by Subcutaneous Injection in Adult Participants With Non-cirrhotic Non-alcoholic Steatohepatitis With FibrosisNon-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
COMPLETED54 Analytics
PHASE2COMPLETED
A Study to Evaluate the Safety and Efficacy of Cotadutide Given by Subcutaneous Injection in Adult Participants With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
NCT0536493154
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Study Endpoints

Primary Endpoints

Number of Participants With Adverse Events (AEs).
First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.

To assess safety and tolerability of Cotadutide. Occurrence of AEs and serious AEs, including AEs leading to dose reduction, and AEs of special interest.

Number of Participants With Abnormal Vital Signs.
First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.

To assess safety and tolerability of Cotadutide.

Number of Participants With Abnormal Laboratory Assessments
First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.

To assess safety and tolerability of Cotadutide.

Number of Participants With Treatment Emergent Abnormality in 12-lead Electrocardiogram (ECG).
First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.

To assess safety and tolerability of Cotadutide.

Number of Treatment-induced Anti-Drug Antibody (ADA) Participants
First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.

To assess the immunogenicity of Cotadutide

Titer of Treatment-induced Anti-Drug Antibody (ADA)
From first dose on Day 1 until the follow-up period, 28 days post last dose (from randomization up to approximately 52 weeks).

To assess the immunogenicity of cotadutide. Titers represent a dilution and are therefore unitless. Summary statistics are based on the maximum observed titer for each ADA positive subject within the time frame.

Absolute bioavailability of the high and the low concentration cotadutide SC formulations
Collection of plasma samples from pre-dose to 72 hours post-dose.

Evaluation of the absolute bioavailability (F) of the SC formulations by comparison of AUCsubcut/AUCIV

Maximum observed concentration (cmax)
Collection of plasma samples from pre-dose to 72 hours post-dose.

Assessment of pharmacokinetics and relative bioavailability of cotadutide solution for injection by measuring maximum observed concentration (cmax)

Relative bioavailability of a high concentration cotadutide SC formulation in comparison to low concentration formulation, in the fasted state
Collection of plasma samples from pre-dose to 72 hours post-dose.

Pharmacokinetic parameters AUC0-t for cotadutide in the high concentration and low concentration regimens

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

Provide additional details on the single dose PK of cotadutide
Collection of plasma samples from pre-dose to 72 hours post-dose.
Number of adverse events (AEs) experienced by subjects
Collection of plasma samples from pre-dose to 72 hours post-dose.
Evaluate immunogenicity for cotadutide administered as low and high concentration SC formulations and an IV formulation
Collection of plasma samples from pre-dose to 72 hours post-dose.
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cotadutide 300μgEXPERIMENTAL -
Placebo 300μgPLACEBO_COMPARATOR -
Cotadutide 600μgEXPERIMENTAL -
Placebo 600μgPLACEBO_COMPARATOR -
Cotadutide solution for injectionEXPERIMENTALPeriod 1, subcutaneous injection of cotadutide solution Period 2, subcutaneous injection of cotadutide solution Period 3, subcutaneous injection of cotadutide solution
PlaceboPLACEBO_COMPARATORPlacebo administered subcutaneously
CotadutideEXPERIMENTALCotadutide administered subcutaneously

Interventions

NameTypeDescription
CotadutideDRUGCotadutide administered subcutaneously once daily
PlaceboDRUGPlacebo administered subcutaneously once daily
cotadutide solution for injectionDRUGcotadutide solution for injection
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites115

Inclusion Criteria: 1. Provision of informed consent 2. Males and female participants ≥ 18 to ≤ 75 years of age (inclusive) at the time of signing the informed consent. 3. Histologically confirmed non-alcoholic steatohepatitis (NASH) per NASH Clinical Research Network (CRN) criteria as diagnosed by...

Countries:United StatesArgentinaAustraliaAustriaCanadaFranceGermanyGreeceIsraelItalyJapanMalaysiaNew ZealandSouth AfricaSouth KoreaSpainTaiwanThailandTurkey (Türkiye)United Kingdom
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Frequently asked questions about Cotadutide

What is Cotadutide used for?

Cotadutide is an investigational drug being studied for Type 2 Diabetes and non-cirrhotic non-alcoholic steatohepatitis with fibrosis. It is in Phase 2 clinical development for these conditions. Cotadutide is being developed by AstraZeneca PLC.

Who makes Cotadutide?

Cotadutide is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker AZN. The drug is currently in Phase 2 clinical trials for Type 2 Diabetes and non-alcoholic steatohepatitis.

What phase is Cotadutide in?

Cotadutide is in Phase 2 clinical development. A Phase 2 study has been completed evaluating the safety and efficacy of Cotadutide in adult participants with non-cirrhotic non-alcoholic steatohepatitis with fibrosis. The drug remains investigational and is not approved.

What clinical trials is Cotadutide in?

Cotadutide has been studied in clinical trials including NCT05364931, a Phase 2 study in participants with non-cirrhotic non-alcoholic steatohepatitis with fibrosis, and NCT04208620, a Phase 1 study in Japanese obese subjects with Type 2 Diabetes. Both trials have been completed.

Is Cotadutide the same as any other drug?

Cotadutide is also known by the name Cotadutide. No other alternative names have been reported for this drug. It is a distinct investigational compound being developed by AstraZeneca PLC for metabolic and liver conditions.