A Study to Investigate Effects of Omega-3 Carboxylic Acids and Dapagliflozin on Liver Fat Content in Diabetic Patients

Phase 2 Completed 223 enrolled AstraZeneca Uppsala Clinical Research, Uppsala, Sweden · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

This study is a double-blind randomized, placebo-controlled, parallel-group, 12 week study performed in up to 5 centres in Sweden to assess the effect of Omega-3 carboxylic acids and dapagliflozin on liver fat in patients with Type 2 diabetes with fatty liver (\>5.5% as measured with magnetic resonance imaging (MRI))

Timeline

Start: 2015-01
Primary completion: 2015-12
Completion: 2015-12

Outcome

Met primary endpoint

registry analysis (superiority or other test); Epanova + Dapagliflozin vs Placebo; p = 0.046; Geometric mean ratio for difference 0.83 (95% CI 0.70 to 1.00) NCT02279407 ↗

paper Only the combination treatment reduced liver PDFF (p = 0.046) and total liver fat volume (relative change, -24%, p = 0.037) in comparison with placebo. PMID 29971527 ↗

Publications

Eriksson JW, Lundkvist P, Jansson PA, Johansson L, Kvarnstrom M, Moris L, Miliotis T, Forsberg GB, Riserus U, Lind L, Oscarsson J. Effects of dapagliflozin and n-3 carboxylic acids on non-alcoholic fatty liver disease in people with type 2 diabetes: a double-blind randomised placebo-controlled study. Diabetologia. 2018 Sep;61(9):1923-1934. doi: 10.1007/s00125-018-4675-2. Epub 2018 Jul 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dapagliflozin	Small molecule	10 mg	Oral
Subject	Epanova	Other / unclassified	4 g	Oral