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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
Date last updated
2/05/2025

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
Active, not 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
Accrual to date
Final
310
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
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United States of America
State/province [4] 0 0
Illinois
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United States of America
State/province [5] 0 0
Indiana
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United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
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Nebraska
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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North Dakota
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United States of America
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Ohio
Country [15] 0 0
United States of America
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South Carolina
Country [16] 0 0
United States of America
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Tennessee
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United States of America
State/province [17] 0 0
Texas
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United States of America
State/province [18] 0 0
Utah
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
Country [20] 0 0
Canada
State/province [20] 0 0
Alberta
Country [21] 0 0
Canada
State/province [21] 0 0
British Columbia
Country [22] 0 0
Canada
State/province [22] 0 0
Nova Scotia
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Canada
State/province [23] 0 0
Ontario
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Canada
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Quebec
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Germany
State/province [25] 0 0
Bad Oeynhausen
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Germany
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Berlin
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Germany
State/province [27] 0 0
Hamburg
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Germany
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Mannheim
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Germany
State/province [29] 0 0
Muenster
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Germany
State/province [30] 0 0
Oldenburg
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Germany
State/province [31] 0 0
Sankt Ingbert
Country [32] 0 0
Japan
State/province [32] 0 0
Suita-shi
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Taiwan
State/province [33] 0 0
Kaohsiung
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Taiwan
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Taichung
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Taiwan
State/province [35] 0 0
Tainan
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Taiwan
State/province [36] 0 0
Taipei
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Blackpool
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Bristol
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Chesterfield
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Leicester
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Rotherham
Country [42] 0 0
United Kingdom
State/province [42] 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
[email protected]
Contact person for scientific queries

Data sharing statement


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