Comparing 3 approaches for obesity
Official title: A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight
A Clinical Study to Compare Efficacy and Safety of Two Different Doses of CagriSema and Semaglutide in Participants With Obesity With or Without Type 2 Diabetes
- Phase 3
- 3 groups
- Sites in Québec, Calgary and 14 more cities
- Recruiting
Interventions
- Medication
Cagrisema
Cagrisema (Cagrilintide and Semaglutide) will be administered subcutaneously.
- Medication
Semaglutide
Semaglutide will be administered subcutaneously.
Canadian Sites (21)
20 of 21 recruiting
- Recruiting
C-Health Partners
Calgary, Alberta
- Recruiting
Kelowna Health and Memory Centre Ltd.
Kelowna, British Columbia
- Recruiting
Medical Arts Health Research Group_Kelowna
Kelowna, British Columbia
- Recruiting
Ocean West Research Clinic
Surrey, British Columbia
- Recruiting
Hilltop Medical Clinic
Surrey, British Columbia
- Recruiting
Dr. M.B. Jones Inc
Victoria, British Columbia
- Recruiting
G.A. Research Associates Ltd.
Moncton, New Brunswick
- Recruiting
Nova Scotia Hlth Halifax
Halifax, Nova Scotia
- Recruiting
Care Access Cape Breton
Sydney, Nova Scotia
- Recruiting
Centricity Research Brampton Endocrinology
Brampton, Ontario
- Recruiting
Hamilton Medical Research Group
Hamilton, Ontario
- Recruiting
Premier Clinical Trial Research Network (PCTRN)
Hamilton, Ontario
- Recruiting
Wharton Medical Clinic Clinical Trials (Hamilton)
Hamilton, Ontario
- Recruiting
Milestone Research
London, Ontario
- Recruiting
Bluewater Clin Res Group Inc
Sarnia, Ontario
- Recruiting
Diabetes Heart Research Centre
Toronto, Ontario
- Recruiting
Diex Recherche Quebec
Québec
- Recruiting
Alpha Recherche Clinique - Lebourgneuf
Québec
- Recruiting
Centre Medical Acadie
Montreal, Quebec
- Recruiting
Centricity Res Pointe-Claire
Pointe-Claire, Quebec
- Not yet recruiting
Apex Trials
Guelph, Ontario
Eligibility Criteria
See who this study is looking for6 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Male or female (sex assigned at birth, inclusive of all gender identities).
- +Age 18 years or above at the time of signing the informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
- +BMI≥ 35.0 kg/m\^2.
- +Participants without T2D: No history of T2D and HbA1c \< 6.5% (48 millimoles per mole (mmol/mol)) Participants with T2D: A history of T2D and HbA1c \< 10% (\< 86 mmol/mol). If a participant without a history of diabetes during the screening periodScreeningThe checks done before joining, to see whether a study fits.Read more → receives an HbA1c result of 6.5% (48 mmol/mol) or higher, the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → or the participant's healthcare provider must confirm the diagnosis of type 2 diabetes before the participant is randomisedRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
Exclusion
- −A self-reported change in body weight \> 5% within 90 days before screeningScreeningThe checks done before joining, to see whether a study fits.Read more →, irrespective of medical records.
- −Use of any glucagon-like-peptide-1 receptor agonist (GLP-1 RA), including medication with GLP-1 RA activity, or amylin analogues, including medication with amylin activity, within 6 months before screening.
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.
Group A receives Cagrisema.
Registry label: A: Cagrisema - dose level 1
Group B, the comparison group, receives Cagrisema.
Registry label: B: Cagrisema - dose level 2
Group C, the comparison group, receives Semaglutide.
Registry label: C: Semaglutide
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?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
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 April 2028.
The main measurement is taken over: From randomisationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → (week 0) to end of treatment (week 72).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Relative change in body weight — measured over From randomisationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → (week 0) to end of treatment (week 72).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07564414 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 CagrisemaDrug
Cagrisema (Cagrilintide and Semaglutide) will be administered subcutaneously.
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 SemaglutideDrug
Semaglutide will be administered subcutaneously.
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?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
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: From randomisationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → (week 0) to end of treatment (week 72).
The study as a whole is currently expected to finish around 2028-04-19.
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 20 locations, including: Québec, Canada; Calgary, Alberta, Canada; Kelowna, British Columbia, Canada; Surrey, British Columbia, Canada; Victoria, British Columbia, Canada; Moncton, New Brunswick, Canada, and 14 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
This clinical study is testing how the study medicine CagriSema helps people living with obesity, with or without type 2 diabetes (T2D), lose weight. The purpose of the study is to find out how safe and effective CagriSema is for body weight loss in these participants. Participants will receive either CagriSema or semaglutide, and which treatment participants receive is decided by chance. CagriSema is a new study medicine being tested, while semaglutide is a medicine that doctors can already prescribe. The study will last for about 83 weeks
Other Sites (4)
Northern Pines Hlth Ctr, PC
Buckley, Michigan, United States
International Diabetes Center
Minneapolis, Minnesota, United States
AES Minneapolis DRS
Richfield, Minnesota, United States
Southgate Medical Group, LLP
West Seneca, New York, 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.