J1I-MC-GZQB

• Research type

  Research Study

• Full title

  A Phase 3b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Retatrutide Treatment in the Maintenance of Weight Reduction in Individuals with Obesity (TRIUMPH-6)

• IRAS ID

  1011077

• Contact name

  Tetiana Rudenok

• Contact email

  EU_lilly_clinical_trials@lilly.com

• Sponsor organisation

  Eli Lilly and Company

• Research summary

  Study GZQB is designed to investigate the efficacy and safety of once weekly treatment of retatrutide maximum tolerated dose (MTD 9 mg or 12 mg) and/or 4 mg compared with placebo for maintenance of body weight reduction.
  Study GZQB will consist of 4 periods:
  - a screening period
  - an open-label lead-in retatrutide treatment period
  - a randomized, double-blind, placebo-controlled treatment period, and
  - a posttreatment safety follow-up period.
  Approximately 586 participants will be enrolled in the open-label treatment period to achieve about 450 participants randomly assigned in a 1:1:1 ratio to receive
  - retatrutide MTD of 9 or 12 mg (approximately150 participants)
  - retatrutide 4 mg (approximately 150 participants), or
  - placebo (approximately 150 participants).

• REC name

  London - City & East Research Ethics Committee

• REC reference

  25/LO/0013

• Date of REC Opinion

  22 Jan 2025

• REC opinion

  Further Information Favourable Opinion