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Arm 3 for Obesity (VISTA Trial)

Phase 2
Waitlist Available
Led By Prof Melanie Davies, MBChB MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Be at least 18 years old at the time of signing the informed consent.
(i) Hypertension (ii) Dyslipidemia or hyperlipidemia (iii) CV disease (iv) Obstructive sleep apnea
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 26 and week 36
Awards & highlights

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

Who is the study for?
This trial is for adults at least 18 years old who are living with obesity (BMI ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2) with at least one weight-related health issue. Specific eligibility details were not provided, so interested individuals should inquire about additional inclusion and exclusion criteria.
What is being tested?
The study is testing the effects of a new drug called AZD5004 compared to a placebo. Participants will take an oral tablet once daily for 36 weeks in this double-blind study, meaning neither they nor the researchers know who gets the real drug or placebo.
What are the potential side effects?
Potential side effects of AZD5004 are not listed but may include typical reactions to weight loss drugs such as nausea, headaches, digestive issues, and fatigue. The exact side effects would be clarified by the research team.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 26 and week 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 26 and week 36 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of participants with weight loss ≥ 5% from baseline weight
Secondary study objectives
Absolute change from baseline in body weight
Percent change in body weight from baseline
Proportion of participants with weight loss ≥ 10% as well as ≥ 15%
+1 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Arm 5Experimental Treatment2 Interventions
00mg dose or placebo
Group II: Arm 4Experimental Treatment2 Interventions
00mg dose or placebo
Group III: Arm 3Experimental Treatment2 Interventions
00mg dose or placebo
Group IV: Arm 2Experimental Treatment2 Interventions
00mg dose or placebo
Group V: Arm 1Experimental Treatment2 Interventions
00mg dose or placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

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Who is running the clinical trial?

AstraZenecaLead Sponsor
4,331 Previous Clinical Trials
288,639,800 Total Patients Enrolled
30 Trials studying Obesity
12,677 Patients Enrolled for Obesity
Prof Melanie Davies, MBChB MDPrincipal InvestigatorDiabetes Research Centre Leicester Diabetes Centre - Bloom University of Leicester
1 Previous Clinical Trials
285 Total Patients Enrolled
1 Trials studying Obesity
285 Patients Enrolled for Obesity
~190 spots leftby Aug 2025
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