NCT07881796Completed
Effect of Dapagliflozin on Metabolic Parameters in Patients With Non-Alcoholic Fatty Liver Disease
Effect of Dapagliflozin on Metabolic Parameters in Patients With Non-Alcoholic Fatty Liver Disease (NAFLD): A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 146 (actual)
- First submitted
- 13 Oct 2026
- Start date
- 15 Apr 2026
- Primary completion date
- 15 Sept 2026
- Lead sponsor
- Shalamar Hospital
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07881796
What you commit to
- Study type: Interventional
- Participants enrolled: 146
- From 15 Apr 2026 to the primary completion date, 15 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of medications known to cause hepatic steatosis (e.g., corticosteroids, methotrexate, tamoxifen) within the past 6 months as per history and medical records.
Other illness
- Presence of other chronic liver diseases, including: Viral hepatitis (HBV or HCV), Autoimmune hepatitis, Wilson's disease, Hemochromatosis.
- History of bariatric surgery as per medical records.
- Active urinary tract infection based on urine analysis report.
- Severe cardiovascular disease
- Active malignancy
- Known hypersensitivity to dapagliflozin or any of its components
Lab values
- Uncontrolled diabetes (HbA1c \> 9 %)
- Renal impairment (eGFR \< 45 mL/min/1.73m²)
Other
- Pregnancy or breastfeeding
Who the study is looking for
- Adults aged 20-70 years
- Diagnosed with NAFLD based on operational definition.
- Body Mass Index (BMI) ≥ 29 kg/m²
Age in the registry: 20 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shalamar Hospital, lahore Coordinator of this site? Confirm its status | Lahore | Pakistan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.