TRIUMPH-7: Adolescent Obesity Trial

Study Overview

TRIUMPH-7 extends the retatrutide clinical program to adolescents aged 12-17, a population with rapidly increasing obesity prevalence and limited approved pharmacological options. The trial was initiated following the EMA’s agreement on a Pediatric Investigation Plan (PIP) for retatrutide in September 2024.

Background

Adolescent Obesity Crisis

Adolescent obesity has reached epidemic proportions globally:

• Approximately 340 million children and adolescents aged 5-19 are overweight or obese
• Adolescent-onset obesity is strongly predictive of adult obesity and metabolic disease
• Pharmacological options are limited: only semaglutide and phentermine-topiramate have pediatric indications for obesity

Regulatory Requirements

Both the EMA and FDA require pediatric studies for obesity drugs:

• EMA: Agreed PIP requires retatrutide evaluation in adolescents 12-17
• FDA: Pediatric Research Equity Act (PREA) mandates pediatric studies unless waived

Study Design

Population

Adolescents aged 12-17 with:

• BMI at or above the 95th percentile for age and sex (obesity)
• At least one weight-related comorbidity or BMI at or above 120% of the 95th percentile

Dose Selection

Lower starting doses and slower escalation compared to adult trials, based on body weight-adjusted pharmacokinetic modeling and Phase 1 data.

Endpoints

Primary endpoints:

• Percent change in BMI from baseline
• Safety and tolerability

Secondary endpoints:

• Proportion achieving at least 5% BMI reduction
• Changes in cardiometabolic parameters
• Quality of life measures (PedsQL)
• Growth and development monitoring

Safety Considerations

Pediatric trials require additional safety monitoring:

• Linear growth assessment (height velocity)
• Bone density monitoring
• Pubertal development tracking
• Nutritional status evaluation
• Psychological well-being assessment
• Long-term follow-up protocol