Study S001549

Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo for the Treatment of Obesity and Weight-Related Comorbidities in Adolescents: A Randomized, Double-Blind, Placebo- Controlled Trial (SURMOUNT-ADOLESCENTS-2)

ClinicalTrials.gov record

Registration

Registration: NCT06439277
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: RECRUITING
Enrollment: 300
Start: 2024-06-03
Primary completion: 2027-10
Lead sponsor: Eli Lilly and Company
Conditions: Obesity; Weight Gain
Interventions: DRUG:Tirzepatide; DRUG:Placebo
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: OTHER:I8F-MC-GPIX

Registered primary outcomes

Percent Change from Baseline in Body Mass Index (BMI) [Baseline, Week 72]
A Composite Endpoint of Normalization or Clinically Significant Improvement in At Least 2 Predefined Weight-Related Comorbidities Present at Screening Without Development of New Predefined Comorbidity or Worsening of Existing Predefined Comorbidity [Baseline, Week 72]

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