Tirzepatide versus placebo in NASH

Phase 1

• Conditions: onalcoholic Steatohepatitis (NASH); MedDRA version: 22.0Level: PTClassification code 10053219Term: Non-alcoholic steatohepatitisSystem Organ Class: 10019805 - Hepatobiliary disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2019-001550-26-IT
• Lead Sponsor: ELI LILLY & COMPANY, LILLY CORPORATE CENTER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-07
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

- Female or male 18 to 80 years of age (inclusive)
- Body Mass Index (BMI) = greater or equal to 27kg/m² and less or equal to 50 kg/m²
- Participants with T2DM (HbA1c = 9.5% at screening, treated with diet and/or exercice, or treated with oral antihyperglycemic medication (as detailed in the protocol))
- Participants without diagnosed T2DM (HbA1c < 6.5% at screening and fasting glucose < 7.0 mmol/L)
- Diagnosis of NASH by liver biopsy
- NAFLD Activity Score (NAS) = 4 with = 1 point for each component
- Fibrosis stage 2 or 3 according to the NASH CRN scoring system
- Stable body weight for at least 3 months. For participants entering the study with a liver biopsy done between 3 to 6 months from the screening visit, body weight must be stable (<5% body weight change) for the period of time between the biopsy and the screening visit.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 156
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

- Alcohol consumption > 14 units/week for women and > 21 units/week for men
- Fibrosis stages 0 and 1 according to the NASH CRN scoring system
- Cirrhosis (fibrosis stage 4)
- Platelet count < 150,000/mm3
- Evidence of other forms of chronic liver disease
- Uncontrolled T2DM

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified