I8F-MC-GPIX: 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)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507655-30-00

Acronym

I8F-MC-GPIX

Enrollment

Registered

2024-09-05

Start date

2024-09-27

Completion date

Unknown

Last updated

2025-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Brief summary

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

Interventions

DRUGTirzepatide

DRUGPlacebo to match LY3298176 injection

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Percent Change from Baseline in Body Mass Index (BMI), A Composite Endpoint of Normalization or Clinically Significant Improvement in At Least 2 Predefined Weight-Related Comorbidities Present at Screening Without Development of a New Predefined Comorbidity Or Worsening of an Existing Predefined Comorbidity	—

Countries

France, Germany, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026