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AZD5004 for Obesity (VISTA Trial)
Phase 2
Recruiting
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
Adults ≥ 18 years of age
BMI of ≥ 30 kg/m2, or ≥ 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
Must not have
History of type 1 diabetes mellitus or type 2 diabetes mellitus
History of acute or chronic pancreatitis
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. Key eligibility details will be provided by the study team.
What is being tested?
The trial is testing AZD5004, a new oral medication, against a placebo over a period of 36 weeks to see its effects on individuals with obesity or overweight conditions. Participants are randomly assigned to either the drug or placebo group.
What are the potential side effects?
Specific side effects of AZD5004 aren't listed here but typically may include digestive issues, changes in appetite, fatigue, and potential metabolic disturbances. The exact side effects will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My BMI is over 27 and I have a condition like high blood pressure, high cholesterol, heart disease, or sleep apnea.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of type 1 or type 2 diabetes.
Select...
I have a history of pancreatitis.
Select...
I have a severe digestive condition or have had major surgery on my upper GI tract.
Select...
I have had or plan to have weight loss surgery or a device fitted.
Select...
I have taken weight loss medication in the last 3 months.
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
6Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 5Experimental Treatment1 Intervention
Active IMP
Group II: Arm 4Experimental Treatment1 Intervention
Active IMP
Group III: Arm 3Experimental Treatment1 Intervention
Active IMP
Group IV: Arm 2Experimental Treatment1 Intervention
Active IMP
Group V: Arm 1Experimental Treatment1 Intervention
Active IMP
Group VI: Arm 6Placebo Group1 Intervention
Matching placebo for each of the 5 active arms
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,427 Previous Clinical Trials
289,164,307 Total Patients Enrolled
31 Trials studying Obesity
12,908 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