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Phase 3Recruiting
View on ClinicalTrials.gov

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

Condition: ObesitySponsor: Novo Nordisk A/STarget enrollment: 2500
  • Phase 3
  • 3 groups
  • Sites in Québec, Calgary and 14 more cities
  • Recruiting
Apex Trials, Guelph, OntarioDiex Recherche Quebec, QuébecAlpha Recherche Clinique - Lebourgneuf, QuébecC-Health Partners, Calgary, AlbertaKelowna Health and Memory Centre Ltd., Kelowna, British ColumbiaMedical Arts Health Research Group_Kelowna, Kelowna, British ColumbiaOcean West Research Clinic, Surrey, British ColumbiaHilltop Medical Clinic, Surrey, British ColumbiaDr. M.B. Jones Inc, Victoria, British ColumbiaG.A. Research Associates Ltd., Moncton, New BrunswickNova Scotia Hlth Halifax, Halifax, Nova ScotiaCare Access Cape Breton, Sydney, Nova ScotiaCentricity Research Brampton Endocrinology, Brampton, OntarioHamilton Medical Research Group, Hamilton, OntarioPremier Clinical Trial Research Network (PCTRN), Hamilton, OntarioWharton Medical Clinic Clinical Trials (Hamilton), Hamilton, OntarioMilestone Research, London, OntarioBluewater Clin Res Group Inc, Sarnia, OntarioDiabetes Heart Research Centre, Toronto, OntarioCentre Medical Acadie, Montreal, QuebecCentricity Res Pointe-Claire, Pointe-Claire, Quebec

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

  • 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

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.
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
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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This 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.