Comparing Semaglutide with Tirzepatide for obesity (disorder)
Official title: Mechanisms of Weight Loss: Tirzepatide vs Semaglutide
Mechanisms of Weight Loss Due to Dual GIP GLP-1 Receptor Agonism With Tirzepatide Compared to Semaglutide: A Randomized Controlled Trial
- Phase 4
- 2 groups
- One site, in Hamilton
- Recruiting
Interventions
- Medication
Tirzepatide
This group will take tirzepatide once weekly for 12 weeks. Participants will be started at 2.5 mg and increase by one dose level every 4 weeks, if tolerated (allowing up to 3 dose levels over 12 weeks), to a maximum dose of 7.5 mg. Dose levels are 2.5 mg, 5 mg, 7.5 mg.
- Medication
Semaglutide
This group will take semaglutide once weekly for 12 weeks. Participants will be started at 0.25 mg and increase by one dose level every 4 weeks, if tolerated (allowing up to 3 dose levels over 12 weeks), to a maximum dose of 1 mg. Dose levels are 0.25 mg, 0.5 mg, 1 mg.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
McMaster University
Hamilton, Ontario
Eligibility Criteria
See who this study is looking for23 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age 18-60 years
- +Body mass index (BMI) \>30 kg/m2
- +Stable body weight (\<5kg change in the 3 months prior to screeningScreeningThe checks done before joining, to see whether a study fits.Read more →)
Exclusion
- −Other medications, allergies or comorbidities that, in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → could interfere with study medication or study measures (e.g., catecholamine medications) or current medication use that has been unstable in the past 8 weeks or expected to change within the next 3 months
- −History of type 1 or type 2 diabetes or current diagnosis
- −Glucose-lowering or weight loss drugs in the last 3 months or planned in the next 3 months
- −Known clinically significant gastric emptying abnormality (for example, severe gastroparesis or gastric outlet obstruction) or chronic GI symptoms (nausea, vomiting, diarrhea, constipation, bloating or unexplained abdominal pain) or chronically take drugs that directly affect GI motility
- −Known liver disease other than non-alcoholic fatty liver disease, or ALT \>3x ULN
- −Intake of standard alcoholic drinks more than 21/week for men, or 14/week for women
- −Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2
- −History of pancreatitis
- −Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia 2
- −Claustrophobia precluding a 24 hour stay in a whole room calorimeter or MRI scan
- −Inability to undergo MRI (weight \>250 kg, incompatible implanted device, e.g., pacemaker)
- −Use of cannabis or its related products (d-9-THC, CBD, d-8-THC, and cannabinol) in the past three months
- −Known monogenic, syndromic hypothalamic causes of obesity
- −Not able to communicate in English
- −History of cardiac conditions that precludes exercise
- −Participation in any intervention clinical study within 90 days before screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
- −History of eating disorder within the last year
- −Currently pregnant/breastfeeding, previous pregnancy within the last 6 months, or unwillingness to use contraception for 3 months
- −Prior or planned bariatric surgery or planned low calorie meal program in the next 3 months
- −Use of nicotine/tobacco that has been unstable in the past 8 weeks or expected to change within the next 3 months (exclusionExclusion criteriaThe things that would prevent someone from taking part.Read more → from MRI visit ONLY)
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 4Phase 4A study of a treatment that is already approved and in use.Read more → — a study of a treatment already approved for use, following it in everyday practice.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Semaglutide.
Registry label: A: Semaglutide
Group B receives Tirzepatide.
Registry label: B: Tirzepatide
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.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
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.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 60 years.
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.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 80 people.
The study is currently expected to finish around December 2029.
The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, 12 Weeks.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
24-hour Energy Expenditure Measured Using Whole Room Indirect Calorimetry — measured over BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, 12 Weeks.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07900074 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 TirzepatideDrug
This group will take tirzepatide once weekly for 12 weeks. Participants will be started at 2.5 mg and increase by one dose level every 4 weeks, if tolerated (allowing up to 3 dose levels over 12 weeks), to a maximum dose of 7.5 mg. Dose levels are 2.5 mg, 5 mg, 7.5 mg.
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
This group will take semaglutide once weekly for 12 weeks. Participants will be started at 0.25 mg and increase by one dose level every 4 weeks, if tolerated (allowing up to 3 dose levels over 12 weeks), to a maximum dose of 1 mg. Dose levels are 0.25 mg, 0.5 mg, 1 mg.
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: an age range of 18 years to 60 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.maximumAge
- 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.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
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 an age range of 18 years to 60 years.
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.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, 12 Weeks.
The study as a whole is currently expected to finish around 2029-12-31.
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 80 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Hamilton, Ontario, Canada.
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 goal of this clinical trial is to determine if there are differences in the effect of 12 weeks of tirzepatide versus semaglutide on energy balance in adults with obesity and without known diabetes. The main questions it aims to answer are: \- Does tirzepatide have a greater effect on energy expenditure or energy extraction than semaglutide? Participants will: * Take tirzepatide or semaglutide once weekly for 12 weeks * Undergo identical baseline and week 12 study visits (including 24-hour whole room indirect calorimeter testing, MRI scan, body composition, 3-day meal plan and stool collection)
If this study interests you
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Save it to your Collection
Keep it with the other studies you are looking at.
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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.