← Back to all trials
Not Yet Recruiting
NCT07829016
GLP-1 Impacts on Weight Management
Conditions: Weight Management, Disordered Eating Behaviors
Sex: All
Ages: 12 Years – 21 Years
Healthy volunteers: No
Enrollment: 100
Sponsor: University of California, San Francisco
Location: University of California San Francisco, Mission Bay Campus San Francisco California
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* 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 \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
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT07829016). StuddyBuddy aggregates publicly available trial information.