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Kinase Inhibitor
AZD6234 for Obesity
Phase 1
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Must not have
Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier)
Participants who cannot communicate reliably with the Investigator
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, 15, 36, and 78 (cohort 1); day 1, 15, 29, 43, 78 and 120 (cohort 2 and 3)
Summary
This trial looked at the health effects of a weight-loss drug in people who are overweight or obese.
Who is the study for?
This trial is for healthy men and women aged 18-55 who are overweight or obese (BMI between 25 and 40 kg/m2) but otherwise in good health. Women must not be able to bear children, either due to being postmenopausal or having undergone certain sterilization surgeries.
What is being tested?
The study tests the safety and effects of a drug called AZD6234 on people who are overweight or obese. Participants will receive either AZD6234 or a placebo, which has no active ingredients, to compare outcomes.
What are the potential side effects?
While specific side effects aren't listed here, common ones may include digestive issues, changes in appetite, fatigue, headaches, and potential allergic reactions. The exact side effects will be monitored throughout the trial.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had or plan to have weight loss surgery or a device fitted.
Select...
I can communicate clearly with my doctor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1, 15, 36, and 78 (cohort 1); day 1, 15, 29, 43, 78 and 120 (cohort 2 and 3)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, 15, 36, and 78 (cohort 1); day 1, 15, 29, 43, 78 and 120 (cohort 2 and 3)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with Adverse Events (AEs) and Serious Adverse Events(SAE)
Secondary study objectives
ADA titer
Area under concentration time curve in the dosing interval (AUCtau)
Area under plasma concentration-time curve from zero to infinity (AUCinf)
+8 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment2 Interventions
Japanese participants will receive repeated doses of AZD6234 or placebo via SC injection
Group II: Cohort 2Experimental Treatment2 Interventions
Participants will receive repeated doses of AZD6234 or placebo via SC injection
Group III: Cohort 1Experimental Treatment2 Interventions
Participants will receive repeated doses of AZD6234 or placebo via SC injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD6234
2022
Completed Phase 1
~60
Placebo
1995
Completed Phase 3
~2670
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,427 Previous Clinical Trials
289,164,376 Total Patients Enrolled
ParexelIndustry Sponsor
314 Previous Clinical Trials
96,710 Total Patients Enrolled