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NCT07817875

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)

StatusRecruiting
PhasePhase 3
Primary completion (estimated)
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Record History

All 4 versions: 4 with changes below.

  1. Site details revised at 7 of 82 sites
  2. Recruitment opened
    • Study sites: 84 to 82
    • Start date changed from estimate of Sep 2026 to Sep 25, 2026
  3. Site details revised at 9 of 84 sites
  4. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Percent Change from Baseline in Body Mass Index (BMI)
Timeframe: Baseline, Week 84

Secondary (13)

Change from Baseline in Body Weight
Change from Baseline in Waist Circumference
Change from Baseline in Blood Pressure
Percent Change from Baseline in Total Cholesterol
Change from Baseline in Fasting Glucose
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Percent Change from Baseline in Fasting Insulin
Change from Baseline in Pediatric Quality of Life Inventory (PedsQL) Score
Change from Baseline in Child Three-Factor Eating Questionnaire (CTFEQr17) Score
Change from Baseline in Height
Change from Baseline in Alanine Aminotransferase (ALT)
Change from Baseline in Aspartate Aminotransferase (AST)
Treatment-Emergent Suicidality from Columbia-Suicide Severity Rating Scale (C-SSRS)
Pharmacokinetics (PK): Average Tirzepatide Concentration at Steady State (Css)

Arms and interventions

TirzepatideExperimental

Participants will receive tirzepatide subcutaneously (SC)

PlaceboPlacebo comparator

Participants will receive placebo SC

Drugs: Tirzepatide, Placebo

Sites

82 sites in 10 countries

United States 41, Poland 8, Israel 6, Spain 6, Italy 5, Mexico 4, Belgium 3, Portugal 3, South Korea 3, Taiwan 3