← Trials/Trial dossier/NCT06579092

VISTA

CompletedPhase 2

Effects of AZD5004 in Adults Who Are Living With Obesity or Overweight With at Least 1 Weight-related Comorbidity

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

Lead sponsor

AstraZeneca

Asset

AZD5004 / ECC5004

Oral · GLP-1 agonist

Listed sites

62

Recruiting sites

Enrollment

310

actual

Study population

Obesity / overweight

Key I/E criterion

BMI ≥30

Primary endpoints

Body weight, % change≥5% weight-loss responders

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06579092
Org study IDD7260C00001
Secondary ID2024-513691-18-00EU CT number

Timeline

Milestones

Study first posted2024-08-30actual
Study start2024-10-08actual
Primary completion2025-11-21actual
Study completion2025-11-21actual
Last update posted2025-12-18actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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).

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.

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Weight & body composition

6 endpoints
Primary/protocol endpoint

Percent change in body weight from baseline

Time frame:26 weeks

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

Achieved Weight Loss ≥ 5% From Baseline

Time frame:26 weeks

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percent change in body weight from baseline

Time frame:36 weeks

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Achieved weight loss ≥ 5% from baseline

Time frame:36 weeks

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Absolute change from baseline in body weight

Time frame:Week 26 and Week 36

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Achieved weight loss ≥ 10% as well as ≥ 15% from baseline

Time frame:Week 26 and Week 36

≥10% weight-loss responders

threshold achievement, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.