Hepatic Steato-FibrosisEarly Phase 1SHIELDNCT06373523
MASLD in Primary Hypothyroidism and Efficacy of Dapaglifozin
A Early Phase 1 study testing Dapagliflozin 10mg Tab and Levothyroxine Replacement daily in people with Hepatic Steato-Fibrosis and Non-Alcoholic Fatty Liver Disease, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Non-alcoholic fatty liver disease (NAFLD) is a global epidemic with a prevalence of 25-40%.Primary Hypothyroidism is one of Endocrinopathies who are at risk of developing NAFLD/NASH and estimated prevalence of Primary Hypothyroidism in NAFLD patients is 10-15 %.Though First line Management is Dietary changes and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatic Steato-Fibrosis, Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Dapagliflozin 10mg Tab and Levothyroxine Replacement daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 15 Jan 2024to 31 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- Patients with Overt Primary hypothyroidism (Low FT3/Low FT4 and TSH>ULN)
Who cannot join
- Patients with Diabetes Mellitus(T1DM AND T2DM)
- Patient with Secondary Hypothyroidism
- Patients with other Endocrinopathies who are at risk of MASLD (T1DM and T2DM, Growth Hormone Insufficiency,Cushing Syndrome)
- Patients with concomitant other etiologies for hepatic steatosis or elevated transaminases (chronic viral hepatitis infection, autoimmune hepatitis, Wilson's disease, hemochromatosis, congestive hepatopathy, primary biliary cholangitis, primary sclerosing cholangitis, biliary tract obstruction)
- Patient with Drug Induced Liver Injury(DILI)
- Patients with Decompensated Cirrhosis or Portal hypertensionPatients with Cirrhosis or Portal hypertension
Show all 13Show fewer
- Patients with HCC or any other malignancy
- Drugs like OCPS
- Patients <18 years of age
- Patients already on Vitamin E or pioglitazone
- Pregnancy/Lactation
- Patients who are too sick to carry out the protocol
- Those who do not consent to participate in the study
Trial locations and contacts
1 site in 1 country.
India1 site
Postgraduate Institute of Medical Education and Research
Chandigarh, Punjab, 160012
About this study
Non-alcoholic fatty liver disease (NAFLD) is a global epidemic with a prevalence of 25-40%.Primary Hypothyroidism is one of Endocrinopathies who are at risk of developing NAFLD/NASH and estimated prevalence of Primary Hypothyroidism in NAFLD patients is 10-15 %.Though First line Management is Dietary changes and lifestyle modifications(LSM),unfortunately Adherence to Lifestyle has been poor,rise of Lean NAFLD is on rise, faster progression of NAFLD,evolving risk factors for NAFLD like endocrinopathies,these push need for Pharmacotherapy.Currently therapies for NAFLD patients without diabetes mellitus (DM) are limited, and are associated with various adverse side effects. Sodium-glucose cotransporter type-2 (SGLT2) inhibitors can reduce hepatic fat content in patients with DM which is independent of glycemic control. However, the role of SGLT2 inhibitors in NAFLD patients without DM has not been investigated.Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) is an emerging non-invasive imaging technique, and is more sensitive than liver biopsy/histology in quantifying liver fat change. Liver stiffness measurement (LSM) by Transient Elastography is a non-invasive method to diagnose fibrosis/cirrhosis with high accuracy.The novelty of utilizing the concept of "drug repositioning" by changing the role of SGLT2 inhibitors in treating DM to treating NAFLD in patients without DM deserves exploration.The investigators propose a double-blind, randomized, placebo-controlled trial to compare the effects of Dapagliflozin (a type of SLGT2 inhibitors) versus placebo (in a 1:1 ratio) in reducing hepatic fat content as measured by MRI-PDFF in NAFLD patients with Primary Hypothyroidism.The study results will determine whether SGLT2 inhibitors can reduce hepatic steatosis/hepatic fibrosis in NAFLD patients with Primary Hypothyroidism.
Read the detailed description
Non-alcoholic fatty liver disease (NAFLD) is a global epidemic with a prevalence of 25-40%.Cirrhosis can occur without intervening NASH .Time line of progression is variable - modified by risk factors.Over all average progression from one disease Stage to another can take up 7 years for NASH while 14 years for NAFLD.In general ,10-30% of patient NAFLD progress to NASH ; Of which 15-25 % progress to advanced fibrosis.Amongst advanced fibrosis,20 % Progress to Cirrhosis over 2 years and 20 % of cirrhotics will have decompensation over 2 years.Overall in NAFLD MCC of mortality - CVD>Extrahepatic cancer > Liver specific mortality ( HCC and Hepatic decompensation).Primary Hypothyroidism is one of Endocrinopathies who are at risk of developing NAFLD/NASH and estimated prevalence of Primary Hypothyroidism in NAFLD patients is 10-15 %.
Though First line Management is Dietary changes and lifestyle modifications(LSM),unfortunately Adherence to Lifestyle has been poor,rise of Lean NAFLD is on rise, faster progression of NAFLD,evolving risk factors for NAFLD like endocrinopathies,these push need for Pharmacotherapy.Currently therapies for NAFLD patients without diabetes mellitus (DM) are limited, and are associated with various adverse side effects. Sodium-glucose cotransporter type-2 (SGLT2) inhibitors can reduce hepatic fat content in patients with DM which is independent of glycemic control. However, the role of SGLT2 inhibitors in NAFLD patients without DM has not been investigated.
Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) is an emerging non-invasive imaging technique, and is more sensitive than liver biopsy/histology in quantifying liver fat change.The Dixon proton density fat fraction sequence is frequently used to determine the liver's fat composition.To estimate PDFF across the entire liver, 9 regions of interest (ROIs) of 200 mm2 to 300 mm2 in the area will be placed in the nine liver segments on the PDFF parametric maps.This fat percentage called PDFF is calculated by the following formula; PDFF
= F / (F +W) x 100% The radiological findings will be examined by the radiology investigator who will be blinded to prior liver fat fraction maps.
Liver stiffness measurement (LSM) by Transient Elastography is a non-invasive method to diagnose fibrosis/cirrhosis with high accuracy.
The novelty of utilizing the concept of "drug repositioning" by changing the role of SGLT2 inhibitors in treating DM to treating NAFLD in patients without DM deserves exploration.
The investigators propose a double-blind, randomized, placebo-controlled trial to compare the effects of Dapagliflozin (a type of SLGT2 inhibitors) versus placebo (in a 1:1 ratio) in reducing hepatic fat content as measured by MRI-PDFF in NAFLD patients with Primary Hypothyroidism.
A total of 60 adult patients will be randomly sampled from the Endocrinology/liver/Internal Medicine clinics from our institute. Dapagliflozin 10mg daily will be given to the treatment arm. The placebo pill will be manufactured to be identical in appearance to the study drug. 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 4, 12 and 28 weeks. They will undergo LSM/CAP at baseline, week 14 and 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. The secondary outcomes will be proportion of participants achieving remission of steatosis (MRI-PDFF <5%) at week 28, reduction of liver fibrosis (LSM) and decrease in steatosis by 1 stage at week 14 and 28, improvement of laboratory results (including liver transaminases and ductal enzymes, fasting glucose, HbA1c, lipid profile), improvement of anthropometric measurements, and cardiovascular events.
The study results will determine whether SGLT2 inhibitors can reduce hepatic steatosis and regress fibrosis in NAFLD patients with Primary Hypothyroidism.
- Being tested
- Dapagliflozin 10mg Tab, Placebo, Levothyroxine Replacement daily
- Keywords
- Dapaglifozin, MRI-PDFF, Primary hypothyroidism
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10mg TabDrug
Also called Dartdapa
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.
PlaceboDrug
Also called Placib
The placebo pills will be manufactured to be identical in appearance to the study drug(Dapaglifozin 10 mg tablet).
Levothyroxine Replacement dailyDrug
Also called LT4
Levothyroxine Replacement daily for 28 weeka
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin Plus levothyroxine Group | Experimental | Dapagliflozin 10mg daily will be given to the treatment arm in addition to Levothyroxine replacement therapy. 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. The secondary outcomes will be proportion of participants achieving remission of steatosis (MRIPDFF <5%) at week 28, reduction of liver fibrosis (LSM) and decrease in hepatic steatosis by 1 stage at week 14 and 28 and other secondary outcomes as mentioned above. Receives: Drug: Dapagliflozin 10mg Tab; Drug: Levothyroxine Replacement daily |
| Levothyroxine daily and Placebo pill identical to Dapaglifozin for 28 weeks | Placebo comparator | The placebo pill will be manufactured to identical in appearance to the Dapaglifozin will be given to the Placebo arm in addition to Levothyroxine replacement therapy. 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. The secondary outcomes will be proportion of participants achieving remission of steatosis (MRI PDFF <5%) at week 28, reduction of liver fibrosis (LSM) and decrease in hepatic steatosis by 1 stage at week 14 and 28 and other secondary outcomes as mentioned above. Receives: Drug: Placebo; Drug: Levothyroxine Replacement daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in liver fat content
Difference in the change in liver fat content between the two groups at week 28 from the baseline as measured by MRI-PDFF
Measured: 28 weeks
Secondary outcomes (3)
Proportion of participants achieving 1 Stage decrease in steatosis at 6 months asassessed by Transient Elastography
Proportion of participants achieving 1 Stage decrease in steatosis at 6 months as assessed by Transient Elastography
Measured: 28 weeks
Changes in Improvement in hepatic fibrosis measured by non invasive parameters like Fib4 score at 3 and 6 months
Changes in Improvement in hepatic fibrosis measured by non invasive parameters like Fib4 score at 3 and 6 months
Measured: 28 weeks
Changes in Lipid Profile at 3 and 6 months
Changes in Lipid Profile at 3 and 6 months
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start15 Jan 2024
- Primary completion15 Jun 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic Steato-FibrosisStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible subjects will be randomly allocated to either the Dapagliflozin group or placebo group (i.e. control group)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashu Rastogi, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Ashu Rastogi, MD,DM, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373523
- Sponsor's protocol ID
- SHIELD
- Acronym
- SHIELD
- Status last verified
- Aug 2026
- First submitted
- 17 Dec 2023
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MASLD in Primary Hypothyroidism and Efficacy of Dapaglifozin
- ClinicalTrials.gov ID
- NCT06373523
- Acronym / sponsor ID
- SHIELD / SHIELD
- Keywords
- Dapaglifozin, MRI-PDFF, Primary hypothyroidism
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Apr 2024 (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.
Non-alcoholic fatty liver disease (NAFLD) is a global epidemic with a prevalence of 25-40%.Primary Hypothyroidism is one of Endocrinopathies who are at risk of developing NAFLD/NASH and estimated prevalence of Primary Hypothyroidism in NAFLD patients is 10-15 %.Though First line Management is Dietary changes and lifestyle modifications(LSM),unfortunately Adherence to Lifestyle has been poor,rise of Lean NAFLD is on rise, faster progression of NAFLD,evolving risk factors for NAFLD like endocrinopathies,these push need for Pharmacotherapy.Currently therapies for NAFLD patients without diabetes mellitus (DM) are limited, and are associated with various adverse side effects. Sodium-glucose cotransporter type-2 (SGLT2) inhibitors can reduce hepatic fat content in patients with DM which is independent of glycemic control. However, the role of SGLT2 inhibitors in NAFLD patients without DM has not been investigated.Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) is an emerging non-invasive imaging technique, and is more sensitive than liver biopsy/histology in quantifying liver fat change. Liver stiffness measurement (LSM) by Transient Elastography is a non-invasive method to diagnose fibrosis/cirrhosis with high accuracy.The novelty of utilizing the concept of "drug repositioning" by changing the role of SGLT2 inhibitors in treating DM to treating NAFLD in patients without DM deserves exploration.The investigators propose a double-blind, randomized, placebo-controlled trial to compare the effects of Dapagliflozin (a type of SLGT2 inhibitors) versus placebo (in a 1:1 ratio) in reducing hepatic fat content as measured by MRI-PDFF in NAFLD patients with Primary Hypothyroidism.The study results will determine whether SGLT2 inhibitors can reduce hepatic steatosis/hepatic fibrosis in NAFLD patients with Primary Hypothyroidism.
Detailed description
Non-alcoholic fatty liver disease (NAFLD) is a global epidemic with a prevalence of 25-40%.Cirrhosis can occur without intervening NASH .Time line of progression is variable - modified by risk factors.Over all average progression from one disease Stage to another can take up 7 years for NASH while 14 years for NAFLD.In general ,10-30% of patient NAFLD progress to NASH ; Of which 15-25 % progress to advanced fibrosis.Amongst advanced fibrosis,20 % Progress to Cirrhosis over 2 years and 20 % of cirrhotics will have decompensation over 2 years.Overall in NAFLD MCC of mortality - CVD>Extrahepatic cancer > Liver specific mortality ( HCC and Hepatic decompensation).Primary Hypothyroidism is one of Endocrinopathies who are at risk of developing NAFLD/NASH and estimated prevalence of Primary Hypothyroidism in NAFLD patients is 10-15 %.
Though First line Management is Dietary changes and lifestyle modifications(LSM),unfortunately Adherence to Lifestyle has been poor,rise of Lean NAFLD is on rise, faster progression of NAFLD,evolving risk factors for NAFLD like endocrinopathies,these push need for Pharmacotherapy.Currently therapies for NAFLD patients without diabetes mellitus (DM) are limited, and are associated with various adverse side effects. Sodium-glucose cotransporter type-2 (SGLT2) inhibitors can reduce hepatic fat content in patients with DM which is independent of glycemic control. However, the role of SGLT2 inhibitors in NAFLD patients without DM has not been investigated.
Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) is an emerging non-invasive imaging technique, and is more sensitive than liver biopsy/histology in quantifying liver fat change.The Dixon proton density fat fraction sequence is frequently used to determine the liver's fat composition.To estimate PDFF across the entire liver, 9 regions of interest (ROIs) of 200 mm2 to 300 mm2 in the area will be placed in the nine liver segments on the PDFF parametric maps.This fat percentage called PDFF is calculated by the following formula; PDFF
= F / (F +W) x 100% The radiological findings will be examined by the radiology investigator who will be blinded to prior liver fat fraction maps.
Liver stiffness measurement (LSM) by Transient Elastography is a non-invasive method to diagnose fibrosis/cirrhosis with high accuracy.
The novelty of utilizing the concept of "drug repositioning" by changing the role of SGLT2 inhibitors in treating DM to treating NAFLD in patients without DM deserves exploration.
The investigators propose a double-blind, randomized, placebo-controlled trial to compare the effects of Dapagliflozin (a type of SLGT2 inhibitors) versus placebo (in a 1:1 ratio) in reducing hepatic fat content as measured by MRI-PDFF in NAFLD patients with Primary Hypothyroidism.
A total of 60 adult patients will be randomly sampled from the Endocrinology/liver/Internal Medicine clinics from our institute. Dapagliflozin 10mg daily will be given to the treatment arm. The placebo pill will be manufactured to be identical in appearance to the study drug. 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 4, 12 and 28 weeks. They will undergo LSM/CAP at baseline, week 14 and 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. The secondary outcomes will be proportion of participants achieving remission of steatosis (MRI-PDFF <5%) at week 28, reduction of liver fibrosis (LSM) and decrease in steatosis by 1 stage at week 14 and 28, improvement of laboratory results (including liver transaminases and ductal enzymes, fasting glucose, HbA1c, lipid profile), improvement of anthropometric measurements, and cardiovascular events.
The study results will determine whether SGLT2 inhibitors can reduce hepatic steatosis and regress fibrosis in NAFLD patients with Primary Hypothyroidism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible subjects will be randomly allocated to either the Dapagliflozin group or placebo group (i.e. control group)
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin Plus levothyroxine Group | Experimental | Drug: Dapagliflozin 10mg Tab, Drug: Levothyroxine Replacement dailyDapagliflozin 10mg daily will be given to the treatment arm in addition to Levothyroxine replacement therapy. 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. The secondary outcomes will be proportion of participants achieving remission of steatosis (MRIPDFF <5%) at week 28, reduction of liver fibrosis (LSM) and decrease in hepatic steatosis by 1 stage at week 14 and 28 and other secondary outcomes as mentioned above. |
| Levothyroxine daily and Placebo pill identical to Dapaglifozin for 28 weeks | Placebo comparator | Drug: Placebo, Drug: Levothyroxine Replacement dailyThe placebo pill will be manufactured to identical in appearance to the Dapaglifozin will be given to the Placebo arm in addition to Levothyroxine replacement therapy. 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. The secondary outcomes will be proportion of participants achieving remission of steatosis (MRI PDFF <5%) at week 28, reduction of liver fibrosis (LSM) and decrease in hepatic steatosis by 1 stage at week 14 and 28 and other secondary outcomes as mentioned above. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-75 years
- Patients with Overt Primary hypothyroidism (Low FT3/Low FT4 and TSH>ULN)
Key exclusion criteria (13 listed)
- Patients with Diabetes Mellitus(T1DM AND T2DM)
- Patient with Secondary Hypothyroidism
- Patients with other Endocrinopathies who are at risk of MASLD (T1DM and T2DM, Growth Hormone Insufficiency,Cushing Syndrome)
- Patients with concomitant other etiologies for hepatic steatosis or elevated transaminases (chronic viral hepatitis infection, autoimmune hepatitis, Wilson's disease, hemochromatosis, congestive hepatopathy, primary biliary cholangitis, primary sclerosing cholangitis, biliary tract obstruction)
- Patient with Drug Induced Liver Injury(DILI)
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 TabAlso: DartdapaDapagliflozin 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 | Dapagliflozin Plus levothyroxine Group |
| PlaceboAlso: PlacibThe placebo pills will be manufactured to be identical in appearance to the study drug(Dapaglifozin 10 mg tablet). | Drug | Levothyroxine daily and Placebo pill identical to Dapaglifozin for 28 weeks |
| Levothyroxine Replacement dailyAlso: LT4Levothyroxine Replacement daily for 28 weeka | Drug | Dapagliflozin Plus levothyroxine Group, Levothyroxine daily and Placebo pill identical to Dapaglifozin for 28 weeks |
Primary outcome
Change in liver fat content
Time frame: 28 weeks
Difference in the change in liver fat content between the two groups at week 28 from the baseline as measured by MRI-PDFF
3 secondary outcomes
Proportion of participants achieving 1 Stage decrease in steatosis at 6 months asassessed by Transient Elastography
Time frame: 28 weeks
Changes in Improvement in hepatic fibrosis measured by non invasive parameters like Fib4 score at 3 and 6 months
Time frame: 28 weeks
Changes in Lipid Profile at 3 and 6 months
Time frame: 28 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
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.
Ashu Rastogi, MD,DM principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dapagliflozin 10mg Tab and Levothyroxine Replacement daily in people with Hepatic Steato-Fibrosis and Non-Alcoholic Fatty Liver Disease, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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 2 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 28 Aug 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 India. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 liver fat content (time frame: 28 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 28 Aug 2026.