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New treatment option for Prader-Willi Syndrome
Official title Tirzepatide in PWS, HO and GNSO
ClinicalTrials.gov ID: NCT06901245
What this study is testing
What is Tirzepatide?
Tirzepatide is an investigational medicine, given as an once-weekly, being studied as a potential treatment for prader-willi syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 26
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
See the full eligibility 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...
- 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
- 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%)
- Cancer within the previous 5 years
- Current participation in an treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Saint Paul, Minnesota, United States
- Nashville, Tennessee, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 26 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saint Paul, Minnesota, United States; Nashville, Tennessee, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.