Testing Tirzepatide against a placebo for obesity
Official title: A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2)
Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo for the Treatment of Obesity and Weight-Related Comorbidities in Adolescents: A Randomized, Double-Blind, Placebo- Controlled Trial (SURMOUNT-ADOLESCENTS-2)
- Phase 3
- 2 groups
- Sites in Hamilton and Sarnia
- Recruiting
Interventions
- Medication
Tirzepatide
Administered SC
- Medication
Placebo
Administered SC
Canadian Sites (3)
1 of 3 recruiting
- Recruiting
Winterberry Research Inc.
Hamilton
- Not yet recruiting
Premier Clinical Trial Network
Hamilton
- Completed
Bluewater Clinical Research Group Inc.
Sarnia
Eligibility Criteria
See who this study is looking for13 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Have body mass index (BMI) equal to or above the 95th percentile for age and sex (on age and gender-specific growth chart for diagnosis of obesity) with at least 2 of the following predefined weight-related comorbidities: hypertension, prediabetes and hypertriglyceridemia.
- +Have history of at least 1 self-reported unsuccessful dietary effort to lose weight.
- +Are capable of giving signed informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → by a legal representative or assent by a study participant (when applicable).
Exclusion
- −Have undergone or plan to undergo a weight reduction procedure during the study, such as, but not limited to
- −gastric bypass
- −sleeve gastrectomy
- −any other procedure intended to result in weight reduction.
- −Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight greater than 5 kg (11 lbs) within 90 days before screeningScreeningThe checks done before joining, to see whether a study fits.Read more → irrespective of medical records
- −Have type 1 diabetes or history of ketoacidosis, or hyperosmolar state
- −Have type 2 diabetes or have a HbA1c \> 6.4% at screening
- −Have a history of chronic or acute pancreatitis
- −Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- −restrictive bariatric surgery, such as Lap-Band gastric banding, or
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 2 groups in this study.
Group A receives Tirzepatide.
Registry label: A: Tirzepatide
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo.
Registry label: B: 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.
Neither you nor the study team would know 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 an age range of 12 years to 17 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 300 people.
The study is currently expected to finish around December 2030.
The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, Week 72.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Percent Change from BaselineBaselineYour starting measurements, taken before treatment begins.Read more → in Body Mass Index (BMI) — measured over Baseline, Week 72.
A Composite EndpointEndpointThe specific thing a study measures to answer its question.Read more → of Normalization or Clinically Significant Improvement in At Least 2 Predefined Weight-Related Comorbidities Present at ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more → Without Development of New Predefined Comorbidity or Worsening of Existing Predefined Comorbidity — measured over Baseline, Week 72.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06439277 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
Administered SC
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
Administered SC
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 12 years to 17 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?
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?
Neither you nor the study team would know 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 an age range of 12 years to 17 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 →, Week 72.
The study as a whole is currently expected to finish around 2030-12.
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 300 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 4 locations, including: Hamilton, Canada; Sarnia, Canada; Buffalo, New York, United States; Syracuse, New York, United States.
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 the study is to assess how tirzepatide impacts bodyweight and cardiovascular risk factors when used in conjunction with healthy nutrition and physical activity in adolescents with obesity and multiple weight related comorbidities. The study will last approximately 76 weeks and may include up to 23 visits. Participants who have completed the primary 72-week GPIX study and have been off treatment for no more than 12 weeks (including the 4-week safety follow-up period), will have the opportunity to receive an additional 156 weeks of treatment with tirzepatide as well as continuing the lifestyle intervention.
Other Sites (2)
UBMD Pediatrics
Buffalo, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
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.