An interventional study of Dapagliflozin (10mg Tab) and Placebo in Non-Alcoholic Fatty Liver Disease, sponsored by Shalamar Hospital. Completed at 1 site in Pakistan. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Shalamar Hospital · Not applicable, Interventional, and Treatment
This study was designed to assess the effect of dapagliflozin on body weight, blood sugar, liver enzymes, and blood fats in adults with non-alcoholic fatty liver disease (NAFLD), a condition involving excess fat accumulation in the liver. The study hypothesis was that changes in these measurements after 12 weeks would differ significantly between participants receiving dapagliflozin and those receiving placebo.
The study was designed as a randomized, single-blind trial at the Department of Medicine, Shalamar Hospital, Lahore. Planned enrolment was 146 adults aged 20-70 years with NAFLD confirmed by ultrasound and a body mass index of at least 29 kg/m². Participants were to be randomly assigned to two equal groups of 73. One group was to receive dapagliflozin 10 mg by mouth once daily for 12 weeks, while the other was to receive an identical-looking placebo tablet containing no active medicine. Participants were to remain unaware of their assigned treatment. Both groups were to receive the same advice regarding diet, weight reduction, physical activity, and management of metabolic risk factors.
The protocol specified measurements of body weight, body mass index, fasting blood sugar, HbA1c-a measure of average blood sugar-and liver enzymes before treatment and after 12 weeks. Blood fats, including cholesterol and triglycerides, and the ultrasound grade of liver fat were also included. Follow-up visits were scheduled every four weeks to assess medication use and record side effects. The planned analysis compared changes from baseline between the two treatment groups.
1,507 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 303 are open to participants now.
This study's enrollment of 146 is above the median of 60 across 1,098 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →Shalamar Hospital is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
73 participants assigned to dapagliflozin 10 mg orally once daily for 12 weeks, alongside standardized lifestyle advice.
Drug: Dapagliflozin (10mg Tab)
73 participants assigned to an identical-looking placebo tablet orally once daily for 12 weeks, alongside standardized lifestyle advice.
Drug: Placebo
Dapagliflozin tablet, 10 mg administered orally once daily for 12 weeks.
An identical-looking tablet containing no active drug, administered orally once daily for 12 weeks.
Change in Body Mass Index
Mean change in body mass index, expressed in kg/m², compared between the dapagliflozin and placebo groups. Body mass index is calculated as weight in kilograms divided by height in metres squared. Weight is measured using a standardized digital weighing scale, and height is measured using a stadiometer.
Time frame: Baseline and 12 weeks
Change in Body Weight
Mean change in body weight, expressed in kilograms, compared between the treatment groups. Weight is measured using a standardized digital weighing scale with participants wearing light clothing and no shoes.
Time frame: Baseline and 12 weeks
Change in Fasting Blood Glucose
Mean change in fasting blood glucose, expressed in mg/dL, compared between the treatment groups. Glucose is measured using a standardized glucose meter after an overnight fast of at least eight hours.
Time frame: Baseline and 12 weeks
Change in Glycated Hemoglobin
Mean change in glycated hemoglobin, expressed in percentage points, compared between the treatment groups. Glycated hemoglobin is measured using high-performance liquid chromatography.
Time frame: Baseline and 12 weeks
Change in Serum Total Cholesterol
Mean change in serum total cholesterol, expressed in mg/dL, compared between the treatment groups. Serum levels are measured using an automated biochemical analyzer.
Time frame: Baseline and 12 weeks
Ran from Apr 2026 to primary completion in Sep 2026, 5 months.
Of 323 non-industry interventional studies with no phase under Non-alcoholic Fatty Liver Disease, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 51. This study's 5 months is below that.
Counting every sponsor, half of 350 studies reached it within 24 months; a quarter within 12 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Dapagliflozin
Non-alcoholic Fatty Liver Disease →
Shalamar Hospital