TRIUMPH-Adolescent: Retatrutide in Adolescents with Obesity
NCT06051734 · Eli Lilly
- Phase
- Phase 3
- Enrollment
- 400 participants
- Est. completion
- Q2 2027
- Sponsor
- Eli Lilly
Background
TRIUMPH-Adolescent evaluates the efficacy and safety of retatrutide in adolescents aged 12–17 years with obesity. The trial is designed to support a potential pediatric indication, following the regulatory pathway established by tirzepatide and semaglutide in adolescent obesity. The primary endpoint is BMI reduction rather than absolute weight loss, consistent with pediatric obesity trial standards.
Primary endpoint
Percent change in BMI from baseline at 52 weeks
Secondary endpoints
- Proportion achieving ≥ 5% BMI reduction
- Change in body weight
- Change in waist circumference
- Change in cardiometabolic risk factors (blood pressure, lipids, glucose)
- Safety and tolerability in adolescent population
Population
Adolescents 12–17 years with obesity (BMI ≥ 95th percentile for age and sex), without type 2 diabetes
Intervention
Retatrutide (dose TBD based on adult Phase 3 data) SC once weekly vs. placebo; dose escalation protocol
Inclusion criteria
Adolescents 12–17 years; BMI ≥ 95th percentile for age and sex; no type 2 diabetes; Tanner stage ≥ 2
Exclusion criteria
Type 2 diabetes; prior bariatric surgery; use of weight-loss medications in prior 3 months; personal or family history of medullary thyroid carcinoma or MEN2; recent cardiovascular event
Trial information sourced from ClinicalTrials.gov and published literature. TryTrutide is not affiliated with Eli Lilly or any trial site. This is not medical advice.