The Effects of Tirzepatide in Young Adults With Prader-Willi Syndrome, Hypothalamic Obesity and General Non-Syndromic Obesity
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- Change in weight
研究概览
简要总结
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.
详细描述
This study is for the following individuals:
- Age 18-26.
- Have Prader-Willi Syndrome, Hypothalamic Obesity, or Obesity unrelated to a genetic syndrome or medical condition.
- Have a BMI in the obesity range
If you/your child decide to take part in the research study, you/your child would participate in the study for approximately 56-60 weeks. During this time the following can be expected:
-
Receive tirzepatide for once-weekly dosing.
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Complete 6 in-person SCH study visits
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Complete 4 telehealth visits.
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Complete the following research procedures:
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Medical Record Review
-
Vital Signs
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Anthropometry (e.g., height, weight, waist measurements)
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Physical Exams
-
Laboratory Tests (e.g., fasting blood draws, urine test)
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Dual-Energy Absorptiometry (DXA) scans
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Questionnaires
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 26 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 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.
研究组 & 干预措施
Prader-Willi Syndrome
Individuals 18-26 years with a BMI in the obesity range (BMI ≥95th percentile for age and sex or ≥30 kg/m2) with genetically confirmed Prader-Willi Syndrome between 18-26 years old.
干预措施: Tirzepatide (Drug)
Hypothalamic Obesity
Individuals 18-26 years with a BMI in the obesity range (BMI ≥95th percentile for age and sex or ≥30 kg/m2) and hypothalamic obesity as defined by damage to the medial hypothalamic region resulting in dysregulation of satiety and energy balance as diagnosed by a physician.
干预措施: Tirzepatide (Drug)
General Non-Syndromic Obesity
Individuals 18-26 years with a BMI in the obesity range (BMI ≥95th percentile for age and sex or ≥30 kg/m2) and general obesity unrelated to a genetic syndrome or underlying medical condition.
干预措施: Tirzepatide (Drug)
结局指标
主要结局
Change in weight
时间窗: 48 weeks
Weight will be measured in kilograms through anthropometric measurements. Change in percent weight from baseline to week 48 of treatment with tirzepatide in young adults with PWS, HO, GNSO and obesity will then be assessed.
次要结局
- Change in BMI(48 weeks)
- Change in fat mass(48 weeks)
- Change in appetite - CoEQ (Control of Eating Questionnaire)(48 weeks)
- Change in appetite - Physician Rated Hyperphagia Severity Scale(48 weeks)
- Change in metabolic markers - fasting lipids(48 weeks)
- Change in metabolic markers - fasting plasma glucose(48 weeks)
- Change in metabolic markers- fasting insulin(48 weeks)
- Change in metabolic markers - hemoglobin A1C(48 weeks)
- Change in metabolic markers- Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)(48 weeks)
研究者
Grace Kim
Principal Investigator
Seattle Children's Hospital