GLP-1 Impacts on Weight Management

NCT07829016 | Not Yet Recruiting DMC

• 1 other identifier: STUDY00000173
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Weight Management; Disordered Eating Behaviors

Keywords

GLP-1RAs; Weight Management

Outcome Measures

Primary Outcomes (1)

• Change in the frequency of Objective Binge Episodes

  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

  6 months

Secondary Outcomes (7)

• 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

Study Arms (1)

Adolescents and Young Adults (12-21)

Adolescents and Young Adults who plan to start GLP-1RA treatment for weight management.

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be 12-21 years olds who plan to begin GLP-1RA treatment for weight management. Participants will be current patients receiving care from UCSF affiliated clinics.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco, Mission Bay Campus

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Disordered Eating Behavior

Condition Hierarchy (Ancestors)

Behavior; Feeding and Eating Disorders; Mental Disorders

Study Officials

• Marissa Raymond-Flesch, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Franziska Plessow, PhD

CONTACT

4153532747; Franziska.Plessow@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)