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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, day 15, day 29 and at follow up (day 43)
Awards & highlights
Study Summary
This trial is testing a new weight loss drug in people who are overweight or obese.
Who is the study for?
This trial is for healthy, overweight or obese adults aged 18 to 55 who are not of childbearing potential. Women must be postmenopausal or surgically sterile. Participants should have a BMI between 25 and 35 kg/m2, weigh at least 50 kg, and have good veins for drawing blood. Japanese heritage participants need both parents and all grandparents to be Japanese.Check my eligibility
What is being tested?
The study tests the safety, tolerability, and how the body processes AZD6234 in single doses compared to a placebo. Some participants will also receive acetaminophen to assess interactions. The trial involves people receiving one dose of either AZD6234 or placebo in varying amounts.See study design
What are the potential side effects?
Potential side effects may include reactions similar to those experienced with drugs having chemical structures like AZD6234 but specific side effects are not listed as this is an early-phase trial assessing safety.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1, day 15, day 29 and at follow up (day 43)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 15, day 29 and at follow up (day 43)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with AEs and Serious Adverse Events(SAE)
Secondary outcome measures
ADA titer
Apparent total body clearance of drug from plasma (SC dosing only) (CL/F)
Apparent volume of distribution based on the terminal phase (SC dosing only) (Vz/F)
+13 moreSide effects data
From 2014 Phase 4 trial • 323 Patients • NCT015872746%
Nausea/ vomiting
5%
Stomach irritation
4%
Dizziness
4%
Drowsiness
3%
Other
100%
80%
60%
40%
20%
0%
Study treatment Arm
Naproxen Alone
Opioid
Skeletal Muscle Relaxant
Trial Design
8Treatment groups
Experimental Treatment
Group I: Cohort 8Experimental Treatment3 Interventions
Participants will receive AZD6234 via SC injection and matching volumes of placebo as a solution via SC injection
Group II: Cohort 7Experimental Treatment3 Interventions
Participants will receive single ascending doses of AZD6234 via SC injection and matching volumes of the placebo as a solution via SC injection
Group III: Cohort 6Experimental Treatment3 Interventions
Participants will receive single ascending doses of AZD6234 via SC injection and matching volumes of the placebo as a solution via SC injection
Group IV: Cohort 5Experimental Treatment3 Interventions
One dose level for SC administration is planned to be investigated for Japanese participants only
Group V: Cohort 4Experimental Treatment3 Interventions
Participants will receive single ascending doses of AZD6234 via IV injection and matching volumes of the placebo as a solution via IV injection
Group VI: Cohort 3Experimental Treatment3 Interventions
Participants will receive single ascending doses of AZD6234 via SC injection and matching volumes of the placebo as a solution via SC injection
Group VII: Cohort 2Experimental Treatment3 Interventions
Participants will receive a single dose of AZD6234 via an SC injection and matching volume of the placebo as a solution via SC injection
Group VIII: Cohort 1Experimental Treatment3 Interventions
Participants will receive single ascending doses of AZD6234 via SC injection and matching volumes of the placebo as a solution via SC
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
Acetaminophen
2017
Completed Phase 4
~2030
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,257 Previous Clinical Trials
288,593,732 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are a Japanese citizen, defined as having both parents and four grandparents who are JapaneseYou have a history or current condition affecting your stomach, liver, kidneys, or any other condition that could affect how your body processes medication.You are a healthy male or female aged 18 to 55 years with suitable veins for cannulation or repeated venipuncture.You follow a vegan diet or have specific dietary restrictions for medical reasons.You have had any significant illness, surgery, or injury within the past 4 weeks before starting the study.You have a history of strong allergic reactions or ongoing allergies that are considered important by the doctor. You may also have had reactions to medications that are similar to AZD6234.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 7
- Group 2: Cohort 8
- Group 3: Cohort 1
- Group 4: Cohort 3
- Group 5: Cohort 4
- Group 6: Cohort 5
- Group 7: Cohort 6
- Group 8: Cohort 2
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the senior demographic being included in this research initiative?
"To be eligible for this research, potential participants must fall within the 18 to 55 age range. Conversely, there are 103 trials available for minors and 573 studies catering towards seniors."
Answered by AI
Has the FDA granted approval for AZD6234?
"Because it is only in phase 1, there is minimal clinical data supporting the safety of AZD6234. Consequently, our team has assigned a score of one to describe its security profile."
Answered by AI
Can I be admitted into this clinical investigation?
"Participants who wish to join this clinical trial must be hale and hearty, as well as fall within the 18-55 age range. At present, 64 individuals are needed for enrolment."
Answered by AI
What is the aggregate participation rate for this research study?
"Verified. Reports on clinicaltrials.gov divulge that this trial, initiated on September 20th 2022, is actively seeking participants. In total, 64 patients need to be sourced between 2 different facilities."
Answered by AI
Are more volunteers needed for this experiment?
"Affirmative. Clinicaltrials.gov has the details that confirm this clinical trial is currently recruiting participants, with initial postings on September 20th 2022 and subsequent updates as recently as November 18th 2022. 64 patients need to be recruited from 2 sites for this research project."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I would like to lose 45 pounds. And maintain that weight.
PatientReceived 1 prior treatment
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