4656: NNC0194-0499 and semaglutide in NASH
Research type
Research Study
Full title
Efficacy and safety investigation of NNC0194-0499 co-administered with semaglutide in subjects with non-alcoholic steatohepatitis: a dose-ranging, placebo-controlled trial
IRAS ID
296568
Contact name
Phillip Newsome
Contact email
Sponsor organisation
Novo Nordisk Ltd
Eudract number
2020-003566-39
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Universal Trial Number , U1111-1255-5551
Duration of Study in the UK
3 years, 0 months, 20 days
Research summary
Non-alcoholic steatohepatitis (NASH) is associated with increased risk of morbidity and mortality. Current treatment options are few and insufficient. First-line of treatment is lifestyle intervention to achieve weight loss (which has been shown to reverse NASH) and treatment of comorbidities (e.g.hyperlipidaemia, hypertension and diabetes).
Semaglutide is a marketed treatment for type 2 diabetes and is currently in phase 3 clinical trials for weight loss and treatment of NASH. Semaglutide is similar to glucagon-like peptide 1 (GLP-1) a hormone normally made in the body.
Evidence is emerging that a combination of drugs with different mechanisms of action may be show greater effectiveness in NASH than any single drugs.
NNC0194-499 is similar to fibroblast growth factor 21 (FGF-21) which is a hormone normally made in the body. Previous research indicates that FGF-21 may be able to reduce fat levels in the blood, fat stores in the liver and inflammation and scarring in the liver.
NNC0174-0833 is similar to amylin which is a hormone normally made in the body. Amylin controls food intake, body weight and metabolism. Early trials indicate that NNC0174-0833 in combination with semaglutide can lead to more weight loss than semaglutide alone.
This trial will assess the safety and effectiveness of three doses of NNC0194-0499 and a single dose of NNC0174-0833, both in combination with semaglutide. The study is randomised, blinded and placebo controlled. Every active treatment has a matching placebo.
During their participation, all subjects will have two injections on the same day every week. Each subject will have a 6 in 7 chance of receiving at least one of the active trial products. For each subject there is a 1 in 7 chance of receiving only placebo injections. Neither the subject or the study staff will know which injections contain active trial products and which contain placebo.
The study will be carried out in hospitals and subjects will participate for approximately 19 months.REC name
London - Central Research Ethics Committee
REC reference
21/LO/0297
Date of REC Opinion
2 Jun 2021
REC opinion
Further Information Favourable Opinion