Efficacy, Safety, and Pharmacokinetics of Tirzepatide (LY3298176) Once Weekly Versus Placebo in Pediatric Participants 6 to Less Than 12 Years of Age Who Have Obesity (ADVANCE-SURMOUNT-KIDS)
Sponsored by Eli Lilly and Company
About this study
The main purpose of this study, performed under Master Protocol J4M-MC-PWMP (NCT06672549), is to evaluate the efficacy, safety, and pharmacokinetics of tirzepatide as an addition to healthy lifestyle in participants 6 to less than 12 years of age, with obesity. Participation in the study will last about 104 weeks. Participants who have completed the primary 104-week PW02 study (including the 4-week safety follow-up period), will have the opportunity to receive an additional 156 weeks of treatment with tirzepatide as well as continuing the lifestyle intervention.
Where this study is enrolling (17)
- I'm interested
University of Arizona
Tucson, Arizona
- Call 805-483-1185 x.947
Carey Chronis MD Pediatric, Infant and Adolescent Medicine
Oxnard, California
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 714-509-8824
Children's Hospital of Orange County
Orange, California
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 407-303-9826
Florida Hospital- Center for Pediatric Research
Orlando, Florida
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 404-256-2593
Children's Healthcare of Atlanta - Center for Advanced Pediatrics
Atlanta, Georgia
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
Show all 17 locations
- I'm interested
Ann and Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois
- Call 502-588-2590
Norton Children's Endocrinology
Louisville, Kentucky
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call (507) 538-7804
Mayo Clinic - PIN
Rochester, Minnesota
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 651-220-5730
Children's Minnesota Pediatric Endocrinology Clinic & McNeeley Diabetes Center
Saint Paul, Minnesota
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call (612) 625-3623
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 252-222-5700 ext. 195
Lucas Research, Inc
Morehead City, North Carolina
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call (216) 636-2828
Cleveland Clinic
Cleveland, Ohio
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 843-518-5646
Coastal Pediatric Associates
Charleston, South Carolina
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 713-500-5010
McGovern Medical School
Houston, Texas
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- I'm interested
Texas Childrens Hospital
Houston, Texas
- Call 804-628-6674
VCU Health - Center for Endocrinology Diabetes and Metabolism
Richmond, Virginia
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call (425) 786-3784
Seattle Children's Research Institute - Hughes Building - PIN
Seattle, Washington
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
Who can participate
Inclusion criteria
- ✓J4M-MC-PW02
- ✓Are 6 to less than 12 years of age (Tanner stage 1 to 5 inclusive)
- ✓Have:
- ✓a body weight of ≥ 40 kilograms (kg) (88 pounds), and
- ✓been diagnosed with obesity, as defined by BMI equal to or above the 95th percentile for age and sex, on age- and sex-specific growth chart
- ✓J4M-MC-PWMP
- ✓Have a history of at least 1 unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification program (diet and exercise counseling for at least 3 months) prior to screening.
- ✓Obesity as defined by BMI equal to or above the 95th percentile for age and sex (on age- and gender-specific growth chart \[CDC-NCHS, 2022\])
Exclusion criteria
- ✕J4M-MC-PW02
- ✕Have a history of
- ✕proliferative diabetic retinopathy
- ✕diabetic macular edema, or
- ✕nonproliferative diabetic retinopathy that requires acute treatment
- ✕J4M-MC-PWMP
- ✕Have undergone or plan to undergo weight reduction procedure during the study, such as, but not limited to:
- ✕gastric bypass
- ✕sleeve gastrectomy
- ✕restrictive bariatric surgery, such as Lap-Band® gastric banding, or
- ✕any other procedure intended to result in weight reduction.
- ✕Have a diagnosis that is a secondary cause of obesity or have a history of abrupt onset of obesity suggesting a secondary cause, such as hypothalamic, monogenetic, syndromic, or endocrine causes.
- ✕Have type 1 diabetes or history of ketoacidosis, or hyperosmolar state.
- ✕Have HbA1c \>9.0% (75 mmol/mol) as measured by central laboratory at screening.
- ✕Have a family or personal history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome Type 2.
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.