Testing AZD6234 against a placebo for obesity or overweight
Official title: A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus
A Phase III Randomised, Double-Blind, Placebo-Controlled Multicentre Trial to Evaluate the Efficacy and Safety of AZD6234 in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity Without Type 2 Diabetes Mellitus (SELENE 1)
- Phase 3
- 3 groups
- Sites in Calgary, New Westminster and 16 more cities
- Recruiting
Interventions
- Medication
AZD6234
IMP injected subcutaneously, once a week. Unit dose strength as per CSP.
- Medication
Placebo
Placebo matching IMP dose injected subcutaneously, once a week.
Canadian Sites (20)
2 of 20 recruiting
- Recruiting
Research Site
Mississauga, Ontario
- Recruiting
Research Site
Stouffville, Ontario
- Not yet recruiting
Research Site
Calgary, Alberta
- Not yet recruiting
Research Site
New Westminster, British Columbia
- Not yet recruiting
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Surrey, British Columbia
- Not yet recruiting
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Victoria, British Columbia
- Not yet recruiting
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Moncton, New Brunswick
- Not yet recruiting
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Truro, Nova Scotia
- Not yet recruiting
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Brampton, Ontario
- Not yet recruiting
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Guelph, Ontario
- Not yet recruiting
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Hamilton, Ontario
- Not yet recruiting
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North York, Ontario
- Not yet recruiting
Research Site
Scarborough Village, Ontario
- Not yet recruiting
Research Site
Stoney Creek, Ontario
- Not yet recruiting
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Toronto, Ontario
- Not yet recruiting
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Montreal, Quebec
- Not yet recruiting
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Québec, Quebec
- Not yet recruiting
Research Site
Québec, Quebec
- Not yet recruiting
Research Site
Saint-Charles-Borromée, Quebec
- Not yet recruiting
Research Site
Sherbrooke, Quebec
Eligibility Criteria
See who this study is looking for11 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Males \& females (inclusive of all gender identities) age ≥18 years
- +BMI ≥30 kg/m2 OR BMI ≥27 kg/m2 with at least one of the following weight related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, heart failure, chronic kidney disease, metabolic dysfunction-associated steatotic liver disease, osteoarthritis of the knee, or stress urinary incontinence
- +Stable body weight (≤5% body weight change) for at least 3 months prior to RandomisationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
- +History of at least one self-reported unsuccessful attempt to lose body weight in their lifetime
Exclusion
- −Obesity primarily caused by other endocrine disorders
- −History of Type 1 or Type 2 Diabetes Mellitus, HbA1c ≥6.5% (48 mmol/mol), and/or treatment with glucose-lowering agent(s) within 3 months prior to ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →
- −Significant hepatobiliary disease and/or any of the following results at Screening:
- −ALT ≥ 3.0 × ULN
- −AST ≥ 3.0 × ULN
- −TBL \> 1.5 × ULN (except for cases of known Gilbert's Syndrome)
- −Has received treatment with a GLP-1 receptor agonist or GLP-1 containing medication for any indication within 3 months before RandomisationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 3 groups in this study.
Groups A and B receive AZD6234.
Registry label: A: AZD6234 Dose 1 · B: AZD6234 Dose 2
Group C, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo.
Registry label: C: Placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 2,500 people.
The study is currently expected to finish around May 2029.
The main measurement is taken over: 68 weeks.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Percent change in body weight from baselineBaselineYour starting measurements, taken before treatment begins.Read more → at 68 weeks of treatment — measured over 68 weeks.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07784725 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About AZD6234Drug
IMP injected subcutaneously, once a week. Unit dose strength as per CSP.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
Placebo matching IMP dose injected subcutaneously, once a week.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 68 weeks.
The study as a whole is currently expected to finish around 2029-05-21.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 2,500 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 24 locations, including: Calgary, Alberta, Canada; New Westminster, British Columbia, Canada; Surrey, British Columbia, Canada; Victoria, British Columbia, Canada; Moncton, New Brunswick, Canada; Truro, Nova Scotia, Canada, and 18 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The study will evaluate how well AZD6234 works and how safe it is in adults with excess weight or obesity. Efficacy of AZD6234 will be compared to placebo in percent body weight change from baseline at 68 weeks of treatment
Other Sites (5)
Research Site
Troy, Michigan, United States
Research Site
Butte, Montana, United States
Research Site
Cortland, New York, United States
Research Site
Renton, Washington, United States
Research Site
Seattle, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.