NCT04976283

Effect of Oral Anti-diabetic Medication on Liver Fat in Subjects With Type II Diabetes and Non-alcoholic Fatty Liver

Status unknown Phase 4 Last updated 18 March 2022

What this trial tests

Phase 4 trial testing Pioglitazone in Diabetes Mellitus, Type 2 in 123 participants. Status unknown.

Timeline

15 September 2021

Primary endpoint
15 May 2023

15 November 2023

Quick facts

Lead sponsor	Getz Pharma
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	123
Start date	15 September 2021
Primary completion	15 May 2023
Estimated completion	15 November 2023
Sites	1 location across Pakistan

Drugs / interventions tested

• Pioglitazone (pioglitazone) — full drug profile →
• Empagliflozin (empagliflozin) — full drug profile →
• Pioglitazone + Empagliflozin — full drug profile →

Conditions studied

• Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
• NASH - Nonalcoholic Steatohepatitis — all drugs for NASH - Nonalcoholic Steatohepatitis →
• NAFLD — all drugs for NAFLD →

Sponsor

Getz Pharma — full company profile →

Who can join

Adults 18 to 60, any sex, with Diabetes Mellitus, Type 2 or NASH - Nonalcoholic Steatohepatitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This randomized clinical trial aims to compare the effect of the pioglitazone and SGLT2 inhibitor combination on liver fat mass, as compared to either drug used alone, with or without background medical therapy of metformin and/or DDP4 inhibitors.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. PPAR-Targeted Therapies in the Treatment of Non-Alcoholic Fatty Liver Disease in Diabetic Patients.
   Lange NF, Graf V, Caussy C, Dufour JF. · · 2022 · cited 52× · PMID 35457120 · DOI 10.3390/ijms23084305
2. Current Clinical Trial Status and Future Prospects of PPAR-Targeted Drugs for Treating Nonalcoholic Fatty Liver Disease.
   Kamata S, Honda A, Ishii I. · · 2023 · cited 42× · PMID 37627329 · DOI 10.3390/biom13081264
3. Non-alcoholic fatty liver disease: Immunological mechanisms and current treatments.
   Petagine L, Zariwala MG, Patel VB. · · 2023 · cited 27× · PMID 37701135 · DOI 10.3748/wjg.v29.i32.4831
4. Understanding NAFLD: From Case Identification to Interventions, Outcomes, and Future Perspectives.
   Clayton-Chubb D, Kemp W, Majeed A, Lubel JS, et al · · 2023 · cited 26× · PMID 36771394 · DOI 10.3390/nu15030687
5. MetALD: Does it require a different therapeutic option?
   Marek GW, Malhi H. · · 2024 · cited 21× · PMID 38820071 · DOI 10.1097/hep.0000000000000935
6. Pharmaceutical Strategies to Improve Druggability of Potential Drug Candidates in Nonalcoholic Fatty Liver Disease Therapy.
   Amatya R, Lee D, Min KA, Shin MC. · · 2023 · cited 9× · PMID 37514148 · DOI 10.3390/pharmaceutics15071963
7. Application of PPAR Ligands and Nanoparticle Technology in Metabolic Steatohepatitis Treatment.
   Vu HT, Nguyen VD, Ikenaga H, Matsubara T. · · 2024 · cited 5× · PMID 39200340 · DOI 10.3390/biomedicines12081876
8. Hepatic Mechanisms of Myocardial Infarction: A New Perspective in Metabolic Dysfunction-Associated Fatty Liver Disease.
   Cui J, Wang W, Xu Q, Zhu M, et al · · 2025 · PMID 40879000 · DOI 10.1161/jaha.124.040775