Tests tirzepatide against placebo in children with obesity
Tests tirzepatide with healthy lifestyle in children aged 6 to 11 with obesity.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Florence, Modena, Novara, Parma, and Roma, ItalySee the 5 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 11 years old?
Source: NCT07817875, who can take part
Where in Italy
- Azienda Ospedaliero-Universitaria MeyerFlorence, ItalyNot yet recruiting
- Azienda Ospedaliera Universitaria Policlinico de ModenaModena, ItalyNot yet recruiting
- Azienda Ospedaliero Universitaria Maggiore della CaritàNovara, ItalyNot yet recruiting
- Azienda Ospedaliero Universitaria di ParmaParma, ItalyNot yet recruiting
- Ospedale Pediatrico Bambino GesùRoma, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT07817875EU 2025-522020-27-00
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
Efficacy, Safety, and Pharmacokinetics of Tirzepatide Once Weekly Versus Placebo in Pediatric Participants 6 to Less Than 12 Years of Age Who Have Obesity: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial
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.
Inclusion: 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: 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 history of; proliferative diabetic retinopathy; diabetic macular edema, or; nonproliferative diabetic retinopathy that requires acute treatment; J4M-MC-PWMP; 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 a family or personal history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome Type 2; Have HbA1c >9.0% (75 mmol/mol) as measured by central laboratory at screening; J4M-MC-PW02.