ADVANCE-ATTAIN
Research type
Research Study
Full title
A Master Protocol for a Randomized, Controlled, Clinical Platform Trial to Investigate the Efficacy and Safety of Interventions for Chronic Weight Management in Pediatric Participants with Obesity or Overweight (ADVANCE) Efficacy, Safety, and Pharmacokinetics of Orforglipron Once Daily Oral versus Placebo in Adolescent Participants Who Have Obesity, or Overweight with Weight-Related Comorbidities: A Randomized, Double-Blind Trial (ADVANCE-ATTAIN-ADOLESCENTS)
IRAS ID
1011053
Contact name
Lilly Clinical Trials information desk
Contact email
Sponsor organisation
Eli Lilly and Co
Research summary
Obesity is a global epidemic that is associated with increased morbidity and mortality. The main study is a phase 3, randomised, controlled platform clinical trial to evaluate the safety of study drugs to treat obesity in paediatric participants with obesity or who are overweight.
The main purpose of ISA1 is to compare the study drug orforglipron with placebo to test how safe it is and how well it works to decrease body max index.
About 125 adolescents will take part in this worldwide study. Participants will have a 4 in 5 chance (80%) of receiving orforglipron and 1 in 5 chance (20%) of receiving placebo, participants will be assigned by chance (randomised).
This study will have the following 5 periods: screening, lead-in, treatment escalation period, treatment maintenance and follow-up.
The study Sponsor is Eli Lilly & Company.
As part of ISA1, participants will undergo a number of procedures such as questionnaires, blood sample collection, physical examinations and X-rays.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
25/EE/0015
Date of REC Opinion
11 Mar 2025
REC opinion
Further Information Favourable Opinion