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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06579092




Registration number
NCT06579092
Ethics application status
Date submitted
28/08/2024
Date registered
30/08/2024

Titles & IDs
Public title
Effects of AZD5004 in Adults Who Are Living With Obesity or Overweight With at Least 1 Weight-related Comorbidity
Scientific title
A Phase IIb Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AZD5004 in Participants Living With Obesity or Overweight With Comorbidity
Secondary ID [1] 0 0
2024-513691-18-00
Secondary ID [2] 0 0
D7260C00001
Universal Trial Number (UTN)
Trial acronym
VISTA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity or Overweight 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AZD5004
Treatment: Drugs - Placebo

Experimental: Arm 1 - Active IMP

Experimental: Arm 2 - Active IMP

Experimental: Arm 3 - Active IMP

Experimental: Arm 4 - Active IMP

Experimental: Arm 5 - Active IMP

Placebo comparator: Arm 6 - Matching placebo for each of the 5 active arms


Treatment: Drugs: AZD5004
AZD5004 film-coated tablet once daily during 36 weeks

Treatment: Drugs: Placebo
Placebo matching AZD5004 film-coated tablet once daily during 36 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent change in body weight from baseline
Timepoint [1] 0 0
26 weeks
Primary outcome [2] 0 0
Proportion of participants with weight loss = 5% from baseline weight
Timepoint [2] 0 0
26 weeks
Secondary outcome [1] 0 0
Percent change in body weight from baseline
Timepoint [1] 0 0
36 weeks
Secondary outcome [2] 0 0
Proportion of participants with weight loss = 5%
Timepoint [2] 0 0
36 weeks
Secondary outcome [3] 0 0
Absolute change from baseline in body weight
Timepoint [3] 0 0
Week 26 and Week 36
Secondary outcome [4] 0 0
Proportion of participants with weight loss = 10% as well as = 15%
Timepoint [4] 0 0
Week 26 and Week 36

Eligibility
Key inclusion criteria
* Adults = 18 years of age.
* BMI of (a) = 30 kg/m2, or (b) = 27 kg/m2 and have a current diagnosis of at least 1 of the following weight-related comorbidities (treated or untreated):

(i) Hypertension (ii) Dyslipidemia or hyperlipidemia (iii) CV disease (iv) Obstructive sleep apnea
* A stable body weight for 3 months prior to Screening (± 5% body weight change).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have obesity induced by other endocrine disorders, such as Cushing's syndrome or monogenic or syndromic obesity such as Prader-Willi syndrome.
* Has received prescription or non-prescription medication for weight loss within the last 3 months prior to Screening.
* Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier).
* History of type 1 diabetes mellitus or type 2 diabetes mellitus.
* Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper GI tract.
* History of acute or chronic pancreatitis.

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
9/12/2025
Actual
Sample size
Target
304
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Heidelberg West
Recruitment hospital [2] 0 0
Research Site - Merewether
Recruitment hospital [3] 0 0
Research Site - St Albans
Recruitment hospital [4] 0 0
Research Site - St Leonards
Recruitment postcode(s) [1] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [2] 0 0
2291 - Merewether
Recruitment postcode(s) [3] 0 0
3021 - St Albans
Recruitment postcode(s) [4] 0 0
2065 - St Leonards
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
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Idaho
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
Nebraska
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
North Dakota
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Utah
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
Canada
State/province [21] 0 0
Alberta
Country [22] 0 0
Canada
State/province [22] 0 0
British Columbia
Country [23] 0 0
Canada
State/province [23] 0 0
Nova Scotia
Country [24] 0 0
Canada
State/province [24] 0 0
Ontario
Country [25] 0 0
Canada
State/province [25] 0 0
Quebec
Country [26] 0 0
Germany
State/province [26] 0 0
Bad Oeynhausen
Country [27] 0 0
Germany
State/province [27] 0 0
Berlin
Country [28] 0 0
Germany
State/province [28] 0 0
Essen
Country [29] 0 0
Germany
State/province [29] 0 0
Falkensee
Country [30] 0 0
Germany
State/province [30] 0 0
Hamburg
Country [31] 0 0
Germany
State/province [31] 0 0
Mannheim
Country [32] 0 0
Germany
State/province [32] 0 0
Muenster
Country [33] 0 0
Germany
State/province [33] 0 0
Oldenburg
Country [34] 0 0
Germany
State/province [34] 0 0
Sankt Ingbert
Country [35] 0 0
Japan
State/province [35] 0 0
Chuo-ku
Country [36] 0 0
Japan
State/province [36] 0 0
Shinjuku-ku
Country [37] 0 0
Japan
State/province [37] 0 0
Suita-shi
Country [38] 0 0
Taiwan
State/province [38] 0 0
Kaohsiung
Country [39] 0 0
Taiwan
State/province [39] 0 0
Taichung
Country [40] 0 0
Taiwan
State/province [40] 0 0
Tainan
Country [41] 0 0
Taiwan
State/province [41] 0 0
Taipei
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Airdrie
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Blackpool
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Bristol
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Chesterfield
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Leicester
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Rotherham
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Witney

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
Prof Melanie Davies, MBChB MD
Address 0 0
Diabetes Research Centre Leicester Diabetes Centre - Bloom University of Leicester
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
information.center@astrazeneca.com
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 Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

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

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

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 PhRMA 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 anonymized individual patient-level data via secure research environment Vivli.org.

Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


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/NCT06579092