Obesity or OverweightPhase 2VISTANCT06579092
Effects of AZD5004 in Adults Who Are Living With Obesity or Overweight With at Least 1 Weight-related Comorbidity
A Phase 2 study testing AZD5004 in people with Obesity or Overweight, run by AstraZeneca at 62 sites in 7 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity or Overweight
- What is being tested?
- AZD5004
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 310 participants
- Where
- 62 sitesin 7 countries
- Study dates
- 8 Oct 2024to 21 Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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):
- 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).
Who cannot join
- 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.
Trial locations and contacts
62 sites in 7 countries.
62 sites in 7 countries
United States30 sites
Research Site
Austin, Texas, 78735
Research Site
Beachwood, Ohio, 44122
Research Site
Chandler, Arizona, 85225
Research Site
Charlottesville, Virginia, 22911
Research Site
Chesterfield, Missouri, 63005
Research Site
Cincinnati, Ohio, 45219
Research Site
Dallas, Texas, 75230
Research Site
Durham, North Carolina, 27701
Research Site
Fargo, North Dakota, 58104
Research Site
Farmington Hills, Michigan, 48334
Research Site
Hialeah, Florida, 33012
Research Site
Houston, Texas, 77040
Research Site
Huntington Park, California, 90255
Research Site
Knoxville, Tennessee, 37912
Research Site
La Mesa, California, 91942
Research Site
Lincoln, California, 95648
Research Site
Lombard, Illinois, 60148
Research Site
Manassas, Virginia, 20110
Research Site
North Charleston, South Carolina, 29405
Research Site
Ogden, Utah, 84405
Research Site
Omaha, Nebraska, 68134
Research Site
Orlando, Florida, 32806
Research Site
Roslindale, Massachusetts, 02131
Research Site
Spartanburg, South Carolina, 29303
Research Site
Valparaiso, Indiana, 46383
Research Site
Vestal, New York, 13850
Research Site
Walnut Creek, California, 94598
Research Site
West Des Moines, Iowa, 50266
Research Site
Wilmington, North Carolina, 28401
Research Site
Woodway, Texas, 76712
Canada10 sites
Research Site
Calgary, Alberta, T2V 4J2
Research Site
Guelph, Ontario, N1G 0B4
Research Site
Halifax, Nova Scotia, B3H 1V7
Research Site
Hamilton, Ontario, L8J 0B6
Research Site
Hamilton, Ontario, L8L 5G8
Research Site
Surrey, British Columbia, V3T 2V6
Research Site
Terrebonne, Quebec, J6X 4P7
Research Site
Toronto, Ontario, M9V 4B4
Research Site
Toronto, Ontario, M9W 4L6
Research Site
Victoria, British Columbia, V8V 4A1
Germany7 sites
Research Site
Bad Oeynhausen, 32545
Research Site
Berlin, 10787
Research Site
Hamburg, 22607
Research Site
Mannheim, 68167
Research Site
Münster, 48145
Research Site
Oldenburg, 23758
Research Site
Sankt Ingbert, 66386
United Kingdom6 sites
Research Site
Blackpool, FY3 7EN
Research Site
Bristol, BS34 6BQ
Research Site
Chesterfield, S40 4AA
Research Site
Leicester, Le5 4PW
Research Site
Rotherham, S65 1DA
Research Site
Witney, OX28 6JS
Australia4 sites
Research Site
Heidelberg, 3081
Research Site
Merewether, 2291
Research Site
St Albans, 3021
Research Site
St Leonards, 2065
Taiwan4 sites
Research Site
Kaohsiung City, 807
Research Site
Taichung, 40447
Research Site
Tainan, 704
Research Site
Taipei, 10048
About this study
Official 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
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
Read the detailed description
This is a Phase IIb, global, randomized, parallel-group, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of 5 doses of AZD5004 compared with placebo, given once daily as an oral tablet or tablets for a duration of 36 weeks, in adults aged 18 years and above, who are living with obesity (BMI ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) and have at least 1 weight-related comorbidity (Hypertension, Dyslipidemia or hyperlipidemia, CV disease and/or Obstructive sleep apnea). Approximately 304 participants will be randomized in the study. The dual primary endpoints are percent change in body weight from baseline at 26 weeks and the proportion of participants with weight loss ≥ 5% of baseline weight at 26 weeks.
- Conditions
- Obesity or Overweight
- Being tested
- AZD5004, Placebo
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD5004Drug
Also called Active IMP
AZD5004 film-coated tablet once daily during 36 weeks
PlaceboDrug
Placebo matching AZD5004 film-coated tablet once daily during 36 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Active IMP Receives: Drug: AZD5004 |
| Arm 2 | Experimental | Active IMP Receives: Drug: AZD5004 |
| Arm 3 | Experimental | Active IMP Receives: Drug: AZD5004 |
| Arm 4 | Experimental | Active IMP Receives: Drug: AZD5004 |
| Arm 5 | Experimental | Active IMP Receives: Drug: AZD5004 |
| Arm 6 | Placebo comparator | Matching placebo for each of the 5 active arms Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in body weight from baseline
To determine whether AZD5004 is superior to placebo for weight loss
Measured: 26 weeks
Achieved Weight Loss ≥ 5% From Baseline
To determine whether AZD5004 is superior to placebo on achieving weight loss ≥ 5% from baseline
Measured: 26 weeks
Secondary outcomes (4)
Percent change in body weight from baseline
To determine whether AZD5004 is superior to placebo for weight loss
Measured: 36 weeks
Achieved weight loss ≥ 5% from baseline
To determine whether AZD5004 is superior to placebo on achieving weight loss ≥ 5% from baseline
Measured: 36 weeks
Absolute change from baseline in body weight
To determine whether AZD5004 is superior to placebo for absolute weight loss
Measured: Week 26 and Week 36
Achieved weight loss ≥ 10% as well as ≥ 15% from baseline
To assess the effect of AZD5004 versus placebo on achieving weight loss ≥ 10% as well as ≥ 15% from baseline
Measured: Week 26 and Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start8 Oct 2024
- Primary completion21 Nov 2025
- Study completion21 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity or OverweightStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof Melanie Davies, MBChB MD, Principal investigator, Diabetes Research Centre Leicester Diabetes Centre - Bloom University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579092
- Sponsor's protocol ID
- D7260C00001
- Other IDs
- 2024-513691-18-00
- Acronym
- VISTA
- Status last verified
- Dec 2025
- First submitted
- 28 Aug 2024
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Davies MJ, Aroda VR, Rosenstock J, Capehorn M, Pedersen SD, Morizzo E, Malhotra S, Johansson PA, Grice D, Andersson A, Rizi EP, Sjostrom CD. Elecoglipron, an oral small molecule GLP-1 receptor agonist in adults with obesity or overweight (VISTA): a multicentre, phase 2, randomised, placebo-controlled clinical trial. Lancet. 2026 Jun 20;407(10547):2503-2514. doi: 10.1016/S0140-6736(26)00748-8. Epub 2026 Jun 8.
PubMed 42259337
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06579092
- Acronym / sponsor ID
- VISTA / D7260C00001
- Conditions
- Obesity or Overweight
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 21 Nov 2025 (actual)
- Study completion
- 21 Nov 2025 (actual)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This is a Phase IIb, global, randomized, parallel-group, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of 5 doses of AZD5004 compared with placebo, given once daily as an oral tablet or tablets for a duration of 36 weeks, in adults aged 18 years and above, who are living with obesity (BMI ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) and have at least 1 weight-related comorbidity (Hypertension, Dyslipidemia or hyperlipidemia, CV disease and/or Obstructive sleep apnea). Approximately 304 participants will be randomized in the study. The dual primary endpoints are percent change in body weight from baseline at 26 weeks and the proportion of participants with weight loss ≥ 5% of baseline weight at 26 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: AZD5004Active IMP |
| Arm 2 | Experimental | Drug: AZD5004Active IMP |
| Arm 3 | Experimental | Drug: AZD5004Active IMP |
| Arm 4 | Experimental | Drug: AZD5004Active IMP |
| Arm 5 | Experimental | Drug: AZD5004Active IMP |
| Arm 6 | Placebo comparator | Drug: PlaceboMatching placebo for each of the 5 active arms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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):
- A stable body weight for 3 months prior to Screening (± 5% body weight change).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD5004Also: Active IMPAZD5004 film-coated tablet once daily during 36 weeks | Drug | Arm 1, Arm 2, Arm 3, Arm 4, Arm 5 |
| PlaceboPlacebo matching AZD5004 film-coated tablet once daily during 36 weeks | Drug | Arm 6 |
Primary outcome
Percent change in body weight from baseline
Time frame: 26 weeks
To determine whether AZD5004 is superior to placebo for weight loss
Achieved Weight Loss ≥ 5% From Baseline
Time frame: 26 weeks
To determine whether AZD5004 is superior to placebo on achieving weight loss ≥ 5% from baseline
4 secondary outcomes
Percent change in body weight from baseline
Time frame: 36 weeks
Achieved weight loss ≥ 5% from baseline
Time frame: 36 weeks
Absolute change from baseline in body weight
Time frame: Week 26 and Week 36
Achieved weight loss ≥ 10% as well as ≥ 15% from baseline
Time frame: Week 26 and Week 36
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Derived from this study: PubMed 42259337Davies MJ, Aroda VR, Rosenstock J, Capehorn M, Pedersen SD, Morizzo E, Malhotra S, Johansson PA, Grice D, Andersson A, Rizi EP, Sjostrom CD. Elecoglipron, an oral small molecule GLP-1 receptor agonist in adults with obesity or overweight (VISTA): a multicentre, phase 2, randomised, placebo-controlled clinical trial. Lancet. 2026 Jun 20;407(10547):2503-2514. doi: 10.1016/S0140-6736(26)00748-8. Epub 2026 Jun 8.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof Melanie Davies, MBChB MD principal investigator
Diabetes Research Centre Leicester Diabetes Centre - Bloom University of Leicester
62 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD5004 in people with Obesity or Overweight, run by AstraZeneca at 62 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in United States, Canada, Germany, United Kingdom, Australia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in body weight from baseline (time frame: 26 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06579092, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.