No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 26
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
36 (estimated)
Sponsor
Grace Kim · Other
Who this trial is looking for
This trial is looking for young adults aged 18 to 26 with obesity, Prader-Willi Syndrome, or hypothalamic obesity. Participants will take a weight loss medication called Tirzepatide for one year to see how it affects their weight and health.
Are You a Good Fit for This Trial?
Must not be takingInsulinSulfonylureaGLP1A inhibitorsDPP4 inhibitors
Rules you outPregnancyPancreatitisChronic kidney diseaseMedullary thyroid carcinomaUncontrolled diabetes
You may be able to join if
I am 18 to 26 years old.
I have obesity or a diagnosis of Prader-Willi Syndrome or hypothalamic obesity.
I have been in a stable care setting for at least 6 months.
I can tolerate blood draws and other study visits.
I can take weekly injections of Tirzepatide.
I have a consistent caregiver if I am not independent.
I have maintained a stable diet and exercise for at least 6 months.
I can use contraception if I can get pregnant.
You may not be able to join if
I have used weight loss medications in the last 3 months.
I am currently using insulin or certain other diabetes medications.
I have had significant weight changes in the last 2 months.
I am pregnant or planning to become pregnant during the study.
I have a history of pancreatitis or certain kidney conditions.
I have uncontrolled diabetes.
I have any significant heart, kidney, or liver disease.
I have had cancer in the last 5 years.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This research study is comparing the effectiveness of a weight loss medication called Tirzepatide in young adults with Prader-Willi Syndrome and/or hypothalamic obesity, as compared to young adults with obesity that is unrelated to a genetic syndrome or underlying medical cause. These groups will be given medication for 1 year to see how weight and other health factors are effected by the medicati…
This research study is comparing the effectiveness of a weight loss medication called Tirzepatide in young adults with Prader-Willi Syndrome and/or hypothalamic obesity, as compared to young adults with obesity that is unrelated to a genetic syndrome or underlying medical cause. These groups will be given medication for 1 year to see how weight and other health factors are effected by the medication.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* Individuals 18-26 years with a BMI in the obesity range (BMI ≥95th percentile for age and sex or ≥30 kg/m2) with either 1) genetically confirmed diagnosis of PWS, 2) hypothalamic obesity as defined by damage to the medial hypothalamic region resulting in dysregulation of satie…
Inclusion Criteria:
* Individuals 18-26 years with a BMI in the obesity range (BMI ≥95th percentile for age and sex or ≥30 kg/m2) with either 1) genetically confirmed diagnosis of PWS, 2) hypothalamic obesity as defined by damage to the medial hypothalamic region resulting in dysregulation of satiety and energy balance as diagnosed by a physician, 3) general obesity unrelated to a genetic syndrome or underlying medical condition
* In a stable care setting at least 6 months prior to enrollment
* Able and willing to participate in study visits including tolerating blood draws, urine samples and tolerate DXA scan.
* Ability to take weekly subcutaneous tirzepatide
* Consistent caregiver if they are not independent
* Stable diet and exercise regimen for at least 6 months prior to enrollment
* Able to use contraceptive methods if able to conceive offspring in order to prevent unintentional pregnancy during the study
Exclusion Criteria:
* Current or recent (within 3 months of start of study drug initiation) use of weight loss medications
* Current use of insulin or sulfonylurea or other medication affecting insulin secretion or GLP1 clearance
* Current or prior use of any GLP1A or DPP4 inhibitor during the 6 months before screening
* Any medications that may affect the study endpoints
* Significant weight change (\>3% weight gain or loss) in the last 2 months prior to enrollment
* Change in dose of chronic endocrine medications (testosterone, estrogen, levothyroxine, or growth hormone medications) \>10%/kg/day for at least 3 months prior to study
* Current pregnancy or desire to become pregnant within study period, current lactation
* History of recurrent pancreatitis, CKD, gastroparesis
* Chronic/acute heart, kidney, or liver disease
* Personal or family history of medullary thyroid carcinoma or MEN syndrome type 2
* Uncontrolled diabetes (A1C \>8.5%)
* DVT
* Cancer within the previous 5 years
* Current participation in an interventional clinical study
* Previous or planned surgical treatment for obesity
* Individuals with current substance abuse equivalnt to moderate or severe based on DSM 5 criteria (Hasin DS, 2013)
* Any suicidal ideation in the past year
* Unable to perform any of the procedures for the study
* Have a body weight, height, and/or width that that prohibits the ability to obtain accurate measurements according to the DXA manufacturer's specification
* Any condition that would prevent successful participation in the study.
Contacts
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