GLP-1 Longitudinal Outcomes in Weight Management
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in the frequency of Objective Binge Episodes
研究概览
简要总结
The goal of this observational study is to learn about the long-term effects of GLP-1RAs (Ozempic, Wegovy, Rybelsus, Mounjaro, or Zepbound) in adolescents and young adults aged 12-21 who will start taking this drug for weight management. The main question it aims to answer is:
How does starting GLP-1RAs impact eating behaviors and mental health symptoms?
Participants starting to take GLP-1RAs as part of their medical care for weight management will answer online survey questions about their experience taking the drug for 1 year.
详细描述
This prospective single-arm observational study will enroll 100 adolescents and young adults 12 to 21 years of age who are initiating a prescribed glucagon-like peptide-1 receptor agonist (GLP-1RA) therapy or related incretin-based therapy for weight management. The study will assess longitudinal changes in eating behaviors and related clinical features from pre-treatment baseline through 6 months of GLP-1RA treatment, spanning treatment initiation, titration, and maintenance. Exploratory cognitive assessments and biomarker collection will examine behavioral and biological correlates of change. After 6 months, participants will be in follow-up and attend a final study visit at their 12-month mark.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and provide informed consent or, for minor participants, able to provide assent with parent/guardian informed consent
- •Age 12 and 21 years at the time of consent
- •Able to read and write in English; for minor participants, at least one parent/guardian must be able to read and write in English or Spanish
- •Willing and able to complete all required in-person and remote study visits and procedures
- •Current binge-eating symptomatology
- •Initiating first-time GLP-1RA therapy or related incretin-based therapy for weight management (Ozempic, Rybelsus, Wegovy)
- •Meets current FDA medication eligibility criteria for prescribed GLP-1RA treatment for weight management: BMI ≥95th percentile OR ≥85th percentile with ≥1 weight-related comorbidity for those <18 years old and a BMI>30 or BMI>26 with ≥1 weight-related comorbidity for those 18 years old and older
- •Has reliable access to prescribed GLP1-RA medication through insurance coverage, self-payment, or discount pharmacy plans and is willing to take it as prescribed for the duration of study participation
- •On a stable regimen of permitted concomitant medications for at least 1 month prior to GLP-1RA initiation. Participants recently taking prohibited medications may be eligible after an adequate wash-out period as applicable (minimum of 5 half-lives).
- •Receiving care in a clinic affiliated with the research study
排除标准
- •Current use of Lisdexamfetamine (Vyvanse) or insufficient washout from such medication prior to GLP-1RA initiation
- •Anticipated medication changes or planned surgical procedures during the study period that, in the investigator's judgment, could affect study participation of interpretation of outcomes
- •Known genetic metabolic or endocrine syndromes associated with obesity, including Prader Willi Syndrome and familial hypercholesterolemia
- •Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- •Type 1 or type 2 diabetes
- •History of pancreatitis
- •Documented uncontrolled thyroid disease
- •History of bariatric surgery
- •Current pregnancy or known plans to become pregnant within the next 6 months
- •Suicidality or any suicide attempts within the past 3 months
- •Current severe depressive symptoms at screening
- •Any medical, psychiatric, behavioral, or other condition, disorder, or circumstance not otherwise specified in the exclusion criteria that, in the investigator's judgment, may compromise participant safety, study participation, or adherence to the protocol
研究组 & 干预措施
Adolescents and Young Adults (12-21)
Adolescents and Young Adults who plan to start GLP-1RA treatment for weight management.
结局指标
主要结局
Change in the frequency of Objective Binge Episodes
时间窗: 6 months
Change in the frequency of OBEs over the past 28 days from baseline to 6 months following GLP-1RA initiation, as measured by the Eating Disorder Examination (EDE) Binge-Eating Module
次要结局
- Change in Frequency of LOC Episodes(Baseline to 6 months)
- Change in Frequency of OBEs(From baseline to 4 months)
- Change in Frequency of LOC Episodes(Baseline to 4 months)
- Change in Disordered Eating Symptom Severity(Baseline to 4-6 months)
- Change in Body Esteem(Baseline to Month 4 and 6)
- Change in Food Noise(Baseline to 4 and 6 months)
- Change in Frequency on Purging Behaviors(Baseline to 4 and 6 Months)