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AZD6234 for Obesity (APRICUS Trial)
Phase 2
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Obesity induced by other endocrine disorders, such as Cushing's syndrome or Prader-Willi syndrome
Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 26 and week 36
Summary
This trial will test the effectiveness, safety, and tolerance of AZD6234 compared to a placebo in male and female participants over 18 years old who are either obese or overweight and have at least
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) and have at least one weight-related health issue. Specific eligibility criteria details were not provided.
What is being tested?
The study tests AZD6234, a potential new medication for weight management, against a placebo. Participants will receive either the real drug or placebo as a weekly subcutaneous injection for 32 weeks in this double-blind study.
What are the potential side effects?
While specific side effects of AZD6234 aren't listed here, common ones may include reactions at the injection site, nausea, headaches, and fatigue. Placebo injections can also cause similar symptoms due to psychological factors.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My obesity is caused by an endocrine disorder like Cushing's or Prader-Willi syndrome.
Select...
I have had or plan to have weight loss surgery or a device fitted.
Select...
I have a history of type 1 or type 2 diabetes.
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
Percent change in body weight from baseline to week 26
Weight loss ≥ 5% from baseline weight to week 26
Secondary study objectives
AZD6234 plasma concentrations
Absolute change in body weight (kg) from baseline to week 26 and week 36
Percent change in body weight from baseline to week 36
+2 moreTrial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 3Experimental Treatment1 Intervention
Dose 3
Group II: Arm 2Experimental Treatment1 Intervention
Dose 2
Group III: Arm 1Experimental Treatment1 Intervention
Dose 1
Group IV: Arm 4Placebo Group1 Intervention
Placebo - Dose matched with each Experimental arm
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD6234
2022
Completed Phase 1
~60
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,425 Previous Clinical Trials
289,140,713 Total Patients Enrolled
31 Trials studying Obesity
12,981 Patients Enrolled for Obesity