NCT06297603

Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Glycemic Control on Basal Insulin, With or Without Metformin and/or SGLT2 Inhibitor (TRANSCEND-T2D-3)

A Phase 3, Randomized, Multicenter, Double-Blind Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly Compared With Placebo in Adult Participants With Type 2 Diabetes, Moderate or Severe Renal Impairment With Inadequate Glycemic Control on Basal Insulin With or Without Metformin and/or SGLT2 Inhibitor

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the efficacy and safety of retatrutide compared with placebo in participants with Type 2 Diabetes and renal impairment, with inadequate glycemic control on basal insulin alone or a combination of basal insulin with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study will last about 14 months and may include up to 22 visits.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Retatrutide	Administered SC
DRUG	Placebo	Administered SC

Timeline

• Start date: 2024-03-15
• Primary completion: 2026-10-01
• Completion: 2026-11-01
• First posted: 2024-03-07
• Last updated: 2025-12-24

Locations

76 sites across 7 countries: United States, Argentina, Brazil, Israel, Mexico, Puerto Rico, United Kingdom

Regulatory

• FDA-regulated drug study