MASLD in Primary Hypothyroidism and Efficacy of Dapaglifozin

EARLY_PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

September 1, 2024

Primary Completion Date

June 30, 2025

Study Completion Date

July 30, 2025

Conditions
Hepatic Steato-FibrosisNon-Alcoholic Fatty Liver Disease
Interventions
DRUG

Dapagliflozin 10mg Tab

Dapagliflozin 10mg daily will be given to the treatment arm.Eligible subjects will be followed up until week 28, and will undergo clinical, anthropometric and laboratory assessments (including liver function test and lipid profile) at baseline, week 14 and week 28. They will undergo LSM and CAP By Transient Elastography at baseline, week 14 and week 28, and MRI-PDFF at baseline and week 28. The primary outcome will be a difference in change of liver fat content (measured by MRI-PDFF) at week 28 from baseline between the two groups.

DRUG

Placebo

The placebo pills will be manufactured to be identical in appearance to the study drug(Dapaglifozin 10 mg tablet).

DRUG

Levothyroxine Replacement daily

Levothyroxine Replacement daily for 28 weeka

Trial Locations (1)

160012

PGIMER, Chandigarh

All Listed Sponsors
lead

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

NCT06373523 - MASLD in Primary Hypothyroidism and Efficacy of Dapaglifozin | Biotech Hunter | Biotech Hunter