GLP-1 Plus Lifestyle for Overall Wellness: Find Your Way Forward

This study is looking at how a medication called Semaglutide, combined with different levels of health behavior and lifestyle treatment (HBLT), can help teenagers aged 12 to 18 who are living with obesity. The study aims to see if Semaglutide can reduce the need for very intensive HBLT by changing how the body handles appetite and cravings. All participants will receive Semaglutide. Researchers will measure changes in Body Mass Index (BMI) after 24 months to see how well the treatments work. You can join if you are 12 to under 18 years old, have a BMI at or above the 95th percentile for your age and sex, and can connect to virtual sessions with a device. People with type 1 or type 2 diabetes cannot participate.

Study design
This is an interventional study planning to enroll 1020 participants. It compares three different doses of health behavior and lifestyle treatment (HBLT) alongside Semaglutide.
What's involved
You will receive treatment with Semaglutide and participate in virtual platform sessions with video. The primary outcome is measured at 24 months.
Compensation
Not stated in the trial record.
Follow-up
Your Body Mass Index (BMI) will be measured at 24 months.

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NCT06977438

GLP-1 Plus Lifestyle for Overall Wellness: Find Your Way Forward

Not Yet Recruiting
PHASE4Ages 12–18InterventionalTreatment
University of Minnesota
~1,020 participants
Updated 2026-06-16 on ClinicalTrials.gov
What's tested:Semaglutide

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Body Mass Index (BMI) Reduction
Measured over 24 months
Obesity, Childhood
1 sites across 1 states
Minnesota1
  • Aaron Kelly, PhD · PRINCIPAL_INVESTIGATOR · University of Minnesota

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Eligibility criteria

Inclusion

Aged 12 to \< 18 years at screening
BMI \>/= 95th percentile based on age and sex at screening
Provide release of information for established primary health provider
Own a device capable of connecting to the virtual platform sessions with video

Exclusion

Diabetes (type 1 or 2) due to safety concerns about proper surveillance of glycemic control virtually
HbA1c \>/= 6.5%
Current or recent (\< 6 months prior to screening) use of FDA-approved obesity medications
Previous metabolic/bariatric surgery or metabolic/bariatric surgery planned during the study period
Hypertriglyceridemia (TG \>/= 500 mg/dL)
Any past or current diagnosis of an eating disorder (i.e. anorexia nervosa, atypical anorexia nervosa, bulimia nervosa)
Major psychiatric disorder (e.g. schizophrenia, bipolar disorder)
Unstable clinically-diagnosed depression, defined as requiring psychiatric hospitalization in the last six months)
History of suicide attempt
History of suicidal ideation or self-harm within 30 days of screening
Patient Health Questionnaire (PHQ-9) score \>/= 15 at screening
Current pregnancy, breast feeding, or plans to become pregnant
Females refusing to use effective contraception
Diagnosis of monogenic obesity due to mutations in POMC, PCSK1, or LEPR
Diagnosis of syndromic obesity including, but not limited to, Bardet Biedl or Prader-Willi Syndrome
History of cholelithiasis without cholecystectomy
History of pancreatitis
Personal history of first-degree relative history of medullary thyroid carcinoma and/or multiple endocrine neoplasia type 2
Known hypersensitivity to GLP1 agonists
Other participants from the same household who are participating in this trial
Any disorder, unwillingness, or inability, which in the investigator's opinion might jeopardize the participant's safety or compliance with the protocol
  • Body Mass Index (BMI) Reduction24 months

    Change in body mass index