SURPASS-EARLY
Research type
Research Study
Full title
A Randomized, Open-Label, Parallel-Group, Two-Arm, Phase 4 Study to Evaluate the Long-Term Efficacy and Safety of Tirzepatide Compared with Intensified Conventional Care in Adults When Initiating Treatment Early in the Course of Type 2 Diabetes (SURPASS-EARLY)
IRAS ID
1005913
Contact name
Janis Bayley
Contact email
Sponsor organisation
Eli Lilly and Company
Clinicaltrials.gov Identifier
Research summary
Patients with type-2 diabetes (T2D) have above normal levels of glucose (sugar) in their blood. T2D is associated with comorbidities such as obesity, hypertension, dyslipidemia, and a higher risk of cardiovascular disease such as heart attack or stroke. To help prevent diabetes related complications, in addition to addressing comorbidities as part of standard care, treatments are used to control the high levels of glucose in the blood. Tirzepatide acts like a group of hormones in the body called incretins. Incretin hormones are released when food is eaten and help to reduce blood glucose levels. Tirzepatide mimics the function of the incretin hormones GIP (glucosedependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) in the body. Treatment with Tirzepatide has been shown to reduce blood glucose levels and result in weight loss in patients with T2D. This study aims to test the hypothesis that, during the course of T2D, when compared to other existing treatment options, early initiation of tirzepatide treatment may improve glycemic control and lower body weight. Existing treatment options are represented in this trial by the intensified conventional care. The intensified conventional care treatments include a range of glucose-lowering medications used in clinical practice and supported by treatment guidelines. SURPASS-EARLY is a randomized, open-label, parallel-group, two-arm, multicenter, multinational, Phase 4 study to investigate the long-term efficacy and safety of tirzepatide 15 mg or maximum tolerated dose compared to intensified conventional care. Patients must be of 18 years of age and have been diagnosed with T2D in the last 4 years that is inadequately controlled with diet, exercise, and metformin. Approximately 780 participants globally will take part in the study including 35 in the UK. Participants will be randomly assigned to receive either tirzepatide or intensified conventional care and the study will last approximately 215 weeks.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
22/SC/0248
Date of REC Opinion
22 Sep 2022
REC opinion
Further Information Favourable Opinion