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AZD5004 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
Female(s) of childbearing potential (FOCBP) must use adequate contraception from enrollment, through the study, after the last dose of IMP. Oral contraceptives are not permitted.
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 26 and week 36
Summary
This trial is testing a new drug, AZD5004, to see if it helps with weight loss and related health issues in adults who are obese or overweight. Participants will take the drug or a
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 belowSelect...
I am at least 18 years old.
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I am using effective birth control that is not the pill during the study.
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I cannot become pregnant.
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I am overweight with a BMI ≥ 30, or ≥ 27 with a related health issue like high blood pressure.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My obesity is caused by a condition like Cushing's syndrome or Prader-Willi syndrome.
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I have taken weight loss medication in the last 3 months.
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I have had or plan to have weight loss surgery or a device fitted.
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I have a history of type 1 or type 2 diabetes.
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I have a history of psychosis or bipolar disorder.
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I have a severe digestive condition or have had major surgery on my upper GI tract.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 26 and week 36
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 26 and week 36
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 moreTrial 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
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,427 Previous Clinical Trials
289,164,326 Total Patients Enrolled
31 Trials studying Obesity
12,927 Patients Enrolled for Obesity
Prof Melanie Davies, MBChB MDPrincipal InvestigatorDiabetes Research Centre Leicester Diabetes Centre - Bloom University of Leicester
1 Previous Clinical Trials
304 Total Patients Enrolled
1 Trials studying Obesity
304 Patients Enrolled for Obesity