RecruitingPhase 3

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)

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

Lead sponsor

Eli Lilly and Company

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Estimated enrollment

150

Study population

Obesity / overweight

Eligibility highlights

•Age 6-11

Primary endpoint

•Body Mass Index (BMI)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07817875

Org study ID27090

Secondary ID2025

Secondary ID2025-522020-27-00

Secondary IDJ4M-MC-PW02Eli Lilly and Company

Secondary IDJ4M-MC-PWMP Master ProtocolEli Lilly and Company

Timeline

Milestones

Study first posted2026-09-14actual

Study start2026-09-25actual

Last update posted2026-11-04actual

Primary completion2029-12estimated (month precision)

Study completion2032-12estimated (month precision)

Assets

Investigational agents

Tirzepatide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age6 Years

Maximum age11 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Glycemic / diabetes

MASH / liver

Cardiometabolic biomarkers

Patient-reported / QoL

Safety / tolerability / PK

Other (unclassified)

Weight & body composition

3 endpoints

Primary/protocol endpoint

Percent Change from Baseline in Body Mass Index (BMI)

Time frame:Baseline, Week 84

percent change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Body Weight

Time frame:Baseline, Week 84

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Waist Circumference

Time frame:Baseline, Week 84

change from baseline, improvement

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Change from Baseline in Fasting Glucose

Time frame:Baseline, Week 84

change from baseline, improvement

Secondary/protocol endpoint

Percent Change from Baseline in Fasting Insulin

Time frame:Baseline, Week 84

percent change from baseline, improvement

MASH / liver

2 endpoints

Secondary/protocol endpoint

Change from Baseline in Alanine Aminotransferase (ALT)

Time frame:Baseline, Week 84

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Aspartate Aminotransferase (AST)

Time frame:Baseline, Week 84

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Change from Baseline in Blood Pressure

Time frame:Baseline, Week 84

change from baseline, improvement

Secondary/protocol endpoint

Percent Change from Baseline in Total Cholesterol

Time frame:Baseline, Week 84

percent change from baseline, improvement

Patient-reported / QoL

2 endpoints

Secondary/protocol endpoint

Change from Baseline in Pediatric Quality of Life Inventory (PedsQL) Score

Time frame:Baseline, Week 84

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Child Three-Factor Eating Questionnaire (CTFEQr17) Score

Time frame:Baseline, Week 84

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Treatment-Emergent Suicidality from Columbia-Suicide Severity Rating Scale (C-SSRS)

Time frame:Baseline, Week 84

descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK): Average Tirzepatide Concentration at Steady State (Css)

Time frame:Baseline through Week 84

concentration, descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change from Baseline in Height

Time frame:Baseline, Week 84

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.