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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05364931




Registration number
NCT05364931
Ethics application status
Date submitted
4/05/2022
Date registered
6/05/2022

Titles & IDs
Public title
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
Scientific title
A Phase II Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study to Evaluate the Safety and Efficacy of Cotadutide in Participants With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
Secondary ID [1] 0 0
2021-005484-53
Secondary ID [2] 0 0
D5671C00006
Universal Trial Number (UTN)
Trial acronym
PROXYMO-ADV
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cotadutide
Treatment: Drugs - Placebo

Experimental: Cotadutide 300µg -

Placebo comparator: Placebo 300µg -

Experimental: Cotadutide 600µg -

Placebo comparator: Placebo 600µg -


Treatment: Drugs: Cotadutide
Cotadutide administered subcutaneously once daily

Treatment: Drugs: Placebo
Placebo administered subcutaneously once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with adverse events (AEs).
Timepoint [1] 0 0
From first dose on Day 1 until the follow-up period, 28 days post last dose
Primary outcome [2] 0 0
Number of participants with abnormal vital signs.
Timepoint [2] 0 0
From first dose on Day 1 until the follow-up period, 28 days post last dose
Primary outcome [3] 0 0
Number of participants with abnormal laboratory assessments
Timepoint [3] 0 0
From first dose on Day 1 until the follow-up period, 28 days post last dose
Primary outcome [4] 0 0
Number of participants with treatment emergent abnormality in 12-lead electrocardiogram (ECG).
Timepoint [4] 0 0
From first dose on Day 1 until the follow-up period, 28 days post last dose
Primary outcome [5] 0 0
Number of Treatment-induced Anti-Drug Antibody (ADA) participants
Timepoint [5] 0 0
From first dose on Day 1 until the follow-up period, 28 days post last dose
Primary outcome [6] 0 0
Titer of Treatment-induced Anti-Drug Antibody (ADA)
Timepoint [6] 0 0
Time Frame: From first dose on Day 1 until the follow-up period, 28 days post last dose

Eligibility
Key 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 histology from a liver biopsy performed = 180 days from randomization and fulfilling all of the following histological criteria:

1. NAS (Non-alcoholic Fatty Liver Disease Activity Score) = 4 with a score of = 1 for each component: steatosis, lobular inflammation, and ballooning
2. Presence of fibrosis stage F2 or F3
4. Women of childbearing potential, non-pregnant and nonbreastfeeding and using appropriate birth control to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of study intervention.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Chronic liver disease of other etiologies.
2. History of cirrhosis and/or hepatic decompensation, including evidence of portal hypertension (e.g. low platelet count, splenomegaly, ascites, history of hepatic encephalopathy, esophageal varices, or variceal bleeding).
3. Clinically significant cardiovascular or cerebrovascular disease within 90 days prior to screening, including but not limited to, myocardial infarction, acute coronary syndrome, unstable angina pectoris, transient ischemic attack, or stroke, or participants who have undergone percutaneous coronary intervention or a coronary artery bypass graft within the past 90 days or who are due to undergo these procedures at the time of screening
4. History of malignant neoplasms within 5 years prior to screening, except for adequately treated basal cell, squamous cell skin cancer, or any in situ carcinoma.
5. Participation in another clinical study with an investigational product administered within the last 30 days or 5 half-lives of the therapy (whichever is longer) at the time of screening or the time of the historical biopsy or concurrent participation in another interventional study of any kind or prior randomization in this study.
6. Severe allergy/hypersensitivity to any of the proposed study treatments or excipients
7. Contraindication to liver biopsy (eg, bleeding diathesis, such as hemophilia, suspected hemangioma, or suspected echinococcal infection) or inability to safely obtain a liver biopsy as determined by the investigator
8. Severely uncontrolled hypertension defined as SBP = 180 mmHg or DBP = 110 mmHg on the average of 2 seated BP measurements after being at rest for at least 10 minutes at screening or randomization 9 Any positive results for human immunodeficiency virus infection, positive results for hepatitis B surface antigen or hepatitis C antibody test along with a positive HCV RNA test.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/04/2024
Sample size
Target
Accrual to date
Final
54
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Heidelberg
Recruitment hospital [2] 0 0
Research Site - Kogarah
Recruitment hospital [3] 0 0
Research Site - Meadowbrook
Recruitment hospital [4] 0 0
Research Site - Melbourne
Recruitment hospital [5] 0 0
Research Site - Westmead
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
4131 - Meadowbrook
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Nevada
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Utah
Country [14] 0 0
Argentina
State/province [14] 0 0
Caba
Country [15] 0 0
Austria
State/province [15] 0 0
Wien
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
France
State/province [18] 0 0
Montpellier Cedex 5
Country [19] 0 0
France
State/province [19] 0 0
Paris
Country [20] 0 0
Germany
State/province [20] 0 0
Dresden
Country [21] 0 0
Germany
State/province [21] 0 0
Konstanz
Country [22] 0 0
Greece
State/province [22] 0 0
Athens
Country [23] 0 0
Greece
State/province [23] 0 0
Ioannina
Country [24] 0 0
Israel
State/province [24] 0 0
Haifa
Country [25] 0 0
Israel
State/province [25] 0 0
Jerusalem
Country [26] 0 0
Israel
State/province [26] 0 0
Nahariya
Country [27] 0 0
Israel
State/province [27] 0 0
Petach-Tikva
Country [28] 0 0
Israel
State/province [28] 0 0
Tel Aviv
Country [29] 0 0
Israel
State/province [29] 0 0
Tel Hashomer
Country [30] 0 0
Italy
State/province [30] 0 0
Catania
Country [31] 0 0
Italy
State/province [31] 0 0
Foggia
Country [32] 0 0
Italy
State/province [32] 0 0
Milano
Country [33] 0 0
Italy
State/province [33] 0 0
Roma
Country [34] 0 0
Italy
State/province [34] 0 0
Rozzano
Country [35] 0 0
Italy
State/province [35] 0 0
San Giovanni Rotondo
Country [36] 0 0
Japan
State/province [36] 0 0
Chiba-shi
Country [37] 0 0
Japan
State/province [37] 0 0
Fukui-shi
Country [38] 0 0
Japan
State/province [38] 0 0
Gifu-shi
Country [39] 0 0
Japan
State/province [39] 0 0
Hiroshima-shi
Country [40] 0 0
Japan
State/province [40] 0 0
Kawasaki-shi
Country [41] 0 0
Japan
State/province [41] 0 0
Kure-shi
Country [42] 0 0
Japan
State/province [42] 0 0
Osaka
Country [43] 0 0
Japan
State/province [43] 0 0
Saga-shi
Country [44] 0 0
Japan
State/province [44] 0 0
Sapporo-shi
Country [45] 0 0
Japan
State/province [45] 0 0
Sendai-shi
Country [46] 0 0
Japan
State/province [46] 0 0
Shinjuku-ku
Country [47] 0 0
Japan
State/province [47] 0 0
Suita-shi
Country [48] 0 0
Japan
State/province [48] 0 0
Takasaki-shi
Country [49] 0 0
Japan
State/province [49] 0 0
Toon-shi
Country [50] 0 0
Japan
State/province [50] 0 0
Yokohama-shi
Country [51] 0 0
Korea, Republic of
State/province [51] 0 0
Busan
Country [52] 0 0
Korea, Republic of
State/province [52] 0 0
Gangwon-do
Country [53] 0 0
Korea, Republic of
State/province [53] 0 0
Jung-gu
Country [54] 0 0
Korea, Republic of
State/province [54] 0 0
Seoul
Country [55] 0 0
Malaysia
State/province [55] 0 0
Kuala Lumpur
Country [56] 0 0
Malaysia
State/province [56] 0 0
Melaka
Country [57] 0 0
Malaysia
State/province [57] 0 0
Seremban
Country [58] 0 0
New Zealand
State/province [58] 0 0
Auckland
Country [59] 0 0
New Zealand
State/province [59] 0 0
Christchurch
Country [60] 0 0
New Zealand
State/province [60] 0 0
Grafton
Country [61] 0 0
South Africa
State/province [61] 0 0
Plumstead
Country [62] 0 0
Spain
State/province [62] 0 0
A Coruña
Country [63] 0 0
Spain
State/province [63] 0 0
Almería
Country [64] 0 0
Spain
State/province [64] 0 0
Lérida
Country [65] 0 0
Spain
State/province [65] 0 0
Madrid
Country [66] 0 0
Spain
State/province [66] 0 0
Malaga
Country [67] 0 0
Spain
State/province [67] 0 0
Sevilla
Country [68] 0 0
Taiwan
State/province [68] 0 0
Kaohsiung
Country [69] 0 0
Taiwan
State/province [69] 0 0
Tainan City
Country [70] 0 0
Taiwan
State/province [70] 0 0
Taipei City
Country [71] 0 0
Thailand
State/province [71] 0 0
Bangkok
Country [72] 0 0
Thailand
State/province [72] 0 0
Hat Yai
Country [73] 0 0
Thailand
State/province [73] 0 0
Khon Kaen
Country [74] 0 0
Turkey
State/province [74] 0 0
Ankara
Country [75] 0 0
Turkey
State/province [75] 0 0
Istanbul
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Aberdeen
Country [77] 0 0
United Kingdom
State/province [77] 0 0
Glasgow
Country [78] 0 0
United Kingdom
State/province [78] 0 0
Ipswich
Country [79] 0 0
United Kingdom
State/province [79] 0 0
Liverpool
Country [80] 0 0
United Kingdom
State/province [80] 0 0
London
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Preston
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Rochdale
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available to whom?
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05364931