What this trial means for you
This study is active, not recruiting — it is not currently taking new participants, but its results may matter for treatments you're considering. It's studying Liraglutide, Placebo for obesity.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
The study looks at how liraglutide works on participant's body weight. Researchers will look at how liraglutide can help children with obesity to lose weight. They will look at how much weight the children will lose, and if there are any side effects. Participants will either get liraglutide or placebo. Which treatment the participants get is decided by chance. Liraglutide is a new medicine for children, but it can already be prescribed by doctors to adults with overweight or obesity. The participant will get 1 injection every day. In addition to taking the medicine, the participants will have talks with the study staff about healthy food choices, how they can be more physically active and what can be done to help the participants to lose weight. The study will last for about 96 weeks (almost 2 years). The participants will have 18 clinic visits and 10 phone or video calls with the study doctor/staff. Participant will have blood samples taken, have 1 test to check the heart, 1 hand X-ray taken and must fill in a diary between some of the visits.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
Inclusion Criteria: * Informed consent of parent(s) or legally acceptable representative of subject and child assent, as age-appropriate, obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * Male or female, aged 6 to below 12 years at the time of signing informed consent * Tanner stage 1-5 pubertal development at the time of signing informed consent * BMI above or equal to 95th percentile, on gender and age-specific growth charts (CDC.gov) * History of failing to lose sufficient weight with lifestyle modification as judged by the investigator For subjects with type 2 diabetes at screening the following inclusion criterion apply in addition: \- Hemoglobin A1c (HbA1c) below or equal to 10.0 percent (86 mmol/mol) as measured by central laboratory at screening Exclusion Criteria: * A self-reported (or by parent(s)/LAR (legally acceptable representative) where applicable) change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records * Treatment with any medication for the indication of obesity within the past 90 days before screening * Type 1 diabetes * Subjects with secondary causes of obesity (for example hypothalamic, monogenic or endocrine causes)
Study sites by state
Arizona
- TMC Hlthcr Clin Res Office — Tucson
Colorado
- Children's Hospital Colorado — Denver
Idaho
- Solaris Clinical Research — Meridian
Louisiana
- Pennington Biom Res Ctr — Baton Rouge
Maryland
- Barry J. Reiner, MD LLC — Baltimore
Minnesota
- University of Minnesota_CPOM — Minneapolis
New York
- UBMD Peds-Div of Endo/Diabetes — Buffalo
Ohio
- PriMed Clinical Research — Dayton
Pennsylvania
- UPMC Child Hosp-Pittsburgh — Pittsburgh
View the official record on ClinicalTrials.gov →
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