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)
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
6 – 11
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
150 (estimated)
Sponsor
Eli Lilly and Company · Industry
Who this trial is looking for
This trial is looking for children aged 6 to less than 12 years who have obesity. Participants will try a new treatment along with healthy lifestyle changes for about two years.
Are You a Good Fit for This Trial?
Rules you outType 1 diabetes
You may be able to join if
I am between 6 and 12 years old.
I weigh at least 40 kilograms (88 pounds).
I have been diagnosed with obesity based on my BMI.
I have tried to lose weight before without success.
You may not be able to join if
I have had severe eye problems related to diabetes.
I am planning to have any weight loss surgery.
I have a medical condition that causes obesity.
I have type 1 diabetes or a history of diabetic complications.
My HbA1c level is above 9.0%.
I have a family history of certain thyroid cancers.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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-we…
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.
Trial Locations
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Eligibility Criteria
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…
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.
Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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