Tirzepatide versus placebo in NASH
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing the Efficacy and Safety of Tirzepatide versus Placebo in Patients with Nonalcoholic Steatohepatitis (NASH)
IRAS ID
272541
Contact name
Pinelopi Manousou
Contact email
Sponsor organisation
Eli Lilly and Company Limited
Eudract number
2019-001550-26
Duration of Study in the UK
2 years, 1 months, 21 days
Research summary
Non-alcoholic steatohepatitis (NASH) is a condition where excess fat is present in liver cells and is associated with inflammation of the liver. Obesity, Type 2 Diabetes (T2DM) and high levels of fats in the blood are associated with the development of NASH. Patients with NASH may develop liver fibrosis (scarring of the liver), which may progress to liver cirrhosis. Liver cirrhosis may cause death unless the patient receives a liver transplant. They may also develop a type of liver cancer. There are currently no medicines approved for the treatment of NASH. Diet and exercise are considered standard treatment, and weight loss has been shown to be beneficial in reducing liver inflammation.
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 (glucose-dependent 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 T2DM. The link between NASH, increased body weight and T2DM suggests that therapies that induce weight loss and improve blood glucose levels may also result in improvement in or resolution of NASH.
This is a Phase 2, multi-centre study investigating the safety and effectiveness of Tirzepatide treatment in patients with NASH, compared to treatment with a placebo. Patients must be 18 years or over, have a diagnosis of NASH confirmed by biopsy and a BMI ≥27kg/m2. Approximately 196 participants will take part in this study; at least 40-65% of these patients will also have a diagnosis of T2DM. Study participants will be randomly assigned to take either Tirzepatide (one of three dosing plans) or placebo and participation in the study will last about 68 weeks.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
19/NW/0707
Date of REC Opinion
23 Jan 2020
REC opinion
Further Information Favourable Opinion