I8F-MC-GPIT
Research type
Research Study
Full title
A Phase 2, Randomized, Double-blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Investigational Tirzepatide Doses in Participants with Type 2 Diabetes and Obesity.
IRAS ID
1009577
Contact name
Michael Wilkewitz
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2023-504561-24
Clinicaltrials.gov Identifier
Research summary
Obesity affects a large number of people worldwide and is associated with increased obesity related diseases including the metabolic condition Type 2 diabetes (T2D). T2D is characterised by impaired control of blood sugar (glycemic control). This is caused by the body's resistance to insulin as well as reduced insulin production by beta cells in the pancreas.
Due to the progressive nature of T2D, many people will require basal insulin therapy usually in combination with oral medications to reach or maintain glycemic goals. Tirzepatide has shown significant improvement in glycemic control and weight reduction when compared to placebo. This randomised study is designed to explore the effect of investigational doses of Tirzepatide when compared with placebo in participants with Type 2 Diabetes and Obesity.
This study consists of a screening period (35 days), a dose increase period (24 weeks), a high dose treatment period (20 weeks), an extension phase (36 weeks), and an after treatment follow-up period (4 weeks).
Approximately 350 participants globally will take part in the study including 35 in the UK. The study will last about 89 weeks.REC name
Wales REC 2
REC reference
24/WA/0074
Date of REC Opinion
29 Apr 2024
REC opinion
Further Information Favourable Opinion