Effects of AZD5004 in Adults Who Are Living With Obesity or Overweight With at Least 1 Weight-related Comorbidity
VISTA
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
2 other identifiers
interventional
310
7 countries
62
Brief Summary
A Phase IIb, global, randomized, parallel-group, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of AZD5004 compared with placebo, given once daily as an oral tablet(s) for 36 weeks, in male and female participants at least 18 years of age who are living with obesity (body mass index \[BMI\] ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) who have at least 1 weight-related comorbidity
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2024
Shorter than P25 for phase_2
62 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2024
CompletedFirst Posted
Study publicly available on registry
August 30, 2024
CompletedStudy Start
First participant enrolled
October 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 21, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 21, 2025
CompletedDecember 18, 2025
December 1, 2025
1.1 years
August 28, 2024
December 17, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Percent change in body weight from baseline
To determine whether AZD5004 is superior to placebo for weight loss
26 weeks
Achieved Weight Loss ≥ 5% From Baseline
To determine whether AZD5004 is superior to placebo on achieving weight loss ≥ 5% from baseline
26 weeks
Secondary Outcomes (4)
Percent change in body weight from baseline
36 weeks
Achieved weight loss ≥ 5% from baseline
36 weeks
Absolute change from baseline in body weight
Week 26 and Week 36
Achieved weight loss ≥ 10% as well as ≥ 15% from baseline
Week 26 and Week 36
Study Arms (6)
Arm 1
EXPERIMENTALActive IMP
Arm 2
EXPERIMENTALActive IMP
Arm 3
EXPERIMENTALActive IMP
Arm 4
EXPERIMENTALActive IMP
Arm 5
EXPERIMENTALActive IMP
Arm 6
PLACEBO COMPARATORMatching placebo for each of the 5 active arms
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (62)
Research Site
Chandler, Arizona, 85225, United States
Research Site
Huntington Park, California, 90255, United States
Research Site
La Mesa, California, 91942, United States
Research Site
Lincoln, California, 95648, United States
Research Site
Walnut Creek, California, 94598, United States
Research Site
Hialeah, Florida, 33012, United States
Research Site
Orlando, Florida, 32806, United States
Research Site
Lombard, Illinois, 60148, United States
Research Site
Valparaiso, Indiana, 46383, United States
Research Site
West Des Moines, Iowa, 50266, United States
Research Site
Roslindale, Massachusetts, 02131, United States
Research Site
Farmington Hills, Michigan, 48334, United States
Research Site
Chesterfield, Missouri, 63005, United States
Research Site
Omaha, Nebraska, 68134, United States
Research Site
Vestal, New York, 13850, United States
Research Site
Durham, North Carolina, 27701, United States
Research Site
Wilmington, North Carolina, 28401, United States
Research Site
Fargo, North Dakota, 58104, United States
Research Site
Beachwood, Ohio, 44122, United States
Research Site
Cincinnati, Ohio, 45219, United States
Research Site
North Charleston, South Carolina, 29405, United States
Research Site
Spartanburg, South Carolina, 29303, United States
Research Site
Knoxville, Tennessee, 37912, United States
Research Site
Austin, Texas, 78735, United States
Research Site
Dallas, Texas, 75230, United States
Research Site
Houston, Texas, 77040, United States
Research Site
Woodway, Texas, 76712, United States
Research Site
Ogden, Utah, 84405, United States
Research Site
Charlottesville, Virginia, 22911, United States
Research Site
Manassas, Virginia, 20110, United States
Research Site
Heidelberg, 3081, Australia
Research Site
Merewether, 2291, Australia
Research Site
St Albans, 3021, Australia
Research Site
St Leonards, 2065, Australia
Research Site
Calgary, Alberta, T2V 4J2, Canada
Research Site
Surrey, British Columbia, V3T 2V6, Canada
Research Site
Victoria, British Columbia, V8V 4A1, Canada
Research Site
Halifax, Nova Scotia, B3H 1V7, Canada
Research Site
Guelph, Ontario, N1G 0B4, Canada
Research Site
Hamilton, Ontario, L8J 0B6, Canada
Research Site
Hamilton, Ontario, L8L 5G8, Canada
Research Site
Toronto, Ontario, M9V 4B4, Canada
Research Site
Toronto, Ontario, M9W 4L6, Canada
Research Site
Terrebonne, Quebec, J6X 4P7, Canada
Research Site
Bad Oeynhausen, 32545, Germany
Research Site
Berlin, 10787, Germany
Research Site
Hamburg, 22607, Germany
Research Site
Mannheim, 68167, Germany
Research Site
Münster, 48145, Germany
Research Site
Oldenburg, 23758, Germany
Research Site
Sankt Ingbert, 66386, Germany
Research Site
Suita-shi, 565-0853, Japan
Research Site
Kaohsiung City, 807, Taiwan
Research Site
Taichung, 40447, Taiwan
Research Site
Tainan, 704, Taiwan
Research Site
Taipei, 10048, Taiwan
Research Site
Blackpool, FY3 7EN, United Kingdom
Research Site
Bristol, BS34 6BQ, United Kingdom
Research Site
Chesterfield, S40 4AA, United Kingdom
Research Site
Leicester, Le5 4PW, United Kingdom
Research Site
Rotherham, S65 1DA, United Kingdom
Research Site
Witney, OX28 6JS, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prof Melanie Davies, MBChB MD
Diabetes Research Centre Leicester Diabetes Centre - Bloom University of Leicester
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2024
First Posted
August 30, 2024
Study Start
October 8, 2024
Primary Completion
November 21, 2025
Study Completion
November 21, 2025
Last Updated
December 18, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 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
- Access Criteria
- 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.
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.