Non-Alcoholic Fatty Liver DiseaseNCT07881796
Effect of Dapagliflozin on Metabolic Parameters in Patients With Non-Alcoholic Fatty Liver Disease
A study testing Dapagliflozin (10mg Tab) in people with Non-Alcoholic Fatty Liver Disease, run by Shalamar Hospital at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Dapagliflozin (10mg Tab)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Apr 2026to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 20-70 years
- Diagnosed with NAFLD based on operational definition.
- Body Mass Index (BMI) ≥ 29 kg/m²
Who cannot join
- Presence of other chronic liver diseases, including: Viral hepatitis (HBV or HCV), Autoimmune hepatitis, Wilson's disease, Hemochromatosis.
- Use of medications known to cause hepatic steatosis (e.g., corticosteroids, methotrexate, tamoxifen) within the past 6 months as per history and medical records.
- History of bariatric surgery as per medical records.
- Active urinary tract infection based on urine analysis report.
- Pregnancy or breastfeeding
- Uncontrolled diabetes (HbA1c > 9 %)
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- Severe cardiovascular disease
- Renal impairment (eGFR < 45 mL/min/1.73m²)
- Active malignancy
- Known hypersensitivity to dapagliflozin or any of its components
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Dapagliflozin on Metabolic Parameters in Patients With Non-Alcoholic Fatty Liver Disease (NAFLD): A Randomized Controlled Trial
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.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Dapagliflozin (10mg Tab), Placebo
- Keywords
- Dapagliflozin, Hepatic steatosis, Sodium-glucose cotransporter 2 inhibitors, Body weight, Body mass index
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin (10mg Tab)Drug
Dapagliflozin tablet, 10 mg administered orally once daily for 12 weeks.
PlaceboDrug
An identical-looking tablet containing no active drug, administered orally once daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group A-Dapagliflozin | Experimental | 73 participants assigned to dapagliflozin 10 mg orally once daily for 12 weeks, alongside standardized lifestyle advice. Receives: Drug: Dapagliflozin (10mg Tab) |
| Group B-Placebo | Placebo comparator | 73 participants assigned to an identical-looking placebo tablet orally once daily for 12 weeks, alongside standardized lifestyle advice. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start15 Apr 2026
- Primary completion15 Sep 2026
- Study completion15 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shalamar Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hina Awan, Shalamar Hospital
- Investigators
- Hina Awan, Principal investigator, Shalamar Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881796
- Sponsor's protocol ID
- Shalamar1
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dapagliflozin on Metabolic Parameters in Patients With Non-Alcoholic Fatty Liver Disease (NAFLD): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07881796
- Acronym / sponsor ID
- Shalamar1
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- Dapagliflozin, Hepatic steatosis, Sodium-glucose cotransporter 2 inhibitors, Body weight, Body mass index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Shalamar HospitalUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 15 Sep 2026 (actual)
- Study completion
- 15 Sep 2026 (actual)
- First posted
- 19 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A-Dapagliflozin | Experimental | Drug: Dapagliflozin (10mg Tab)73 participants assigned to dapagliflozin 10 mg orally once daily for 12 weeks, alongside standardized lifestyle advice. |
| Group B-Placebo | Placebo comparator | Drug: Placebo73 participants assigned to an identical-looking placebo tablet orally once daily for 12 weeks, alongside standardized lifestyle advice. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 20-70 years
- Diagnosed with NAFLD based on operational definition.
- Body Mass Index (BMI) ≥ 29 kg/m²
Key exclusion criteria (10 listed)
- Presence of other chronic liver diseases, including: Viral hepatitis (HBV or HCV), Autoimmune hepatitis, Wilson's disease, Hemochromatosis.
- Use of medications known to cause hepatic steatosis (e.g., corticosteroids, methotrexate, tamoxifen) within the past 6 months as per history and medical records.
- History of bariatric surgery as per medical records.
- Active urinary tract infection based on urine analysis report.
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin (10mg Tab)Dapagliflozin tablet, 10 mg administered orally once daily for 12 weeks. | Drug | Group A-Dapagliflozin |
| PlaceboAn identical-looking tablet containing no active drug, administered orally once daily for 12 weeks. | Drug | Group B-Placebo |
Primary outcome
Change in Body Mass Index
Time frame: Baseline and 12 weeks
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.
4 secondary outcomes
Change in Body Weight
Time frame: Baseline and 12 weeks
Change in Fasting Blood Glucose
Time frame: Baseline and 12 weeks
Change in Glycated Hemoglobin
Time frame: Baseline and 12 weeks
Change in Serum Total Cholesterol
Time frame: Baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hina Awan principal investigator
Shalamar Hospital, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dapagliflozin (10mg Tab) in people with Non-Alcoholic Fatty Liver Disease, run by Shalamar Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Mass Index (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.