Liver Transplant; ComplicationsSema-LitNCT06060392
Effect of Oral Semaglutide on Liver Fat and Body Composition in Liver Transplant Recipients With Diabetes Mellitus
A study testing Semaglutide Pill in people with Liver Transplant; Complications and Diabete Mellitus, run by Medanta, The Medicity, India at 1 site in India.
Trial summary
Nonalcoholic fatty liver disease (NAFLD) is a spectrum of liver conditions ranging from liver steatosis (NAFL), steatohepatitis (NASH), advanced liver fibrosis and ultimately leads to cirrhosis in a significant proportion of individuals. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Liver Transplant; Complications, Diabete Mellitus
- What is being tested?
- Semaglutide Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 30 Oct 2023to 1 Nov 2025
- Phase
- Interventional
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A man or woman, 30 years of age or above with liver transplantation of at least 3 months duration who meets all the following two criteria:
- On standard anti-diabetic agents (metformin and/or insulin) with an HbA1c of <=9% at screening
- Body mass index of >25 kg/m2
- Subjects must be medically stable based on medical history, physical examination, and laboratory investigations.
- Subjects must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
- Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of the study and are willing to participate in the study.
Who cannot join
- History of diabetic ketoacidosis, type 1 diabetes, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy.
- History of brittle or labile glycemic control, with widely varying glucose measurements by FPG or SMBG such that stable glucose control over the treatment period would be unlikely.
- History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 3 years before Screening, or an Alcohol Use Disorders Identification Test (AUDIT) with a score >=8, or alcohol consumption of more than 20 g per day in the case of women and more than 30 g per day in the case of men for at least three consecutive months during the previous 5 years.
- Thyroid stimulating hormone (TSH) value that is either < 0.45 mIU/L or >10 mIU/L at Screening.
- Note: Subjects on thyroid hormone replacement therapy must be on a stable dose and dosing regimen for at least 4 weeks prior to enrollment.
- Use of a PPAR-γ agonist [e.g., a thiazolidinedione (pioglitazone], an SGLT2 inhibitor (e.g., canagliflozin, empagliflozin, dapagliflozin) or GLP-1 receptor agonists (e.g., liraglutide, dulaglutide) within 12 weeks before the enrollment.
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- Ongoing eating disorder, or a significant weight loss or weight gain within 12 weeks before the Screening visit, defined as an increase or decrease of 5% in body weight based upon clinic-based measurement or, if not available, based on subject's report.
- Myocardial infarction, unstable angina, pulmonary hypertension, revascularization procedure (e.g., stent or bypass graft surgery), or cerebrovascular accident within 3 months before Screening, or revascularization procedure is planned, or subject has a history of New York Heart Association (NYHA) Class III-IV cardiac disease.
- Use of vitamin E within 4 weeks before screening.
- History of prior bariatric (e.g., Roux-en-Y gastric bypass) or other major upper gastrointestinal surgical procedure (including gastric resection).
- History of diabetic gastroparesis (or symptoms suggestive of this disorder, including postprandial bloating or vomiting), malabsorption, inflammatory bowel disease, or any other chronic, clinically important gastrointestinal disorder.
- Estimated glomerular filtration rate (eGFR) <45 mL/min/1•73 m2 using the Modification of Diet in Renal Disease Study (MDRD) equation.
- Subjects with a history of having or possibly having metallic material in the body or any contraindication for a MR examination.
- Claustrophobia, or anxiety related to previous negative experiences with magnetic resonance imaging procedures or if the subject is unwilling to participate in magnetic resonance imaging procedures.
- Clinically important hematologic disorder (e.g., symptomatic anemia, proliferative bone marrow disorder, thrombocytopenia) at Screening.
- History of human immunodeficiency virus (HIV) antibody positive at Screening.
- Contraindications to the use of oral semaglutide (per ORAL SEMAGLUTIDE Prescribing Information).
- Pregnancy or women breastfeeding or planning to become pregnant while enrolled in this study.
- History of significant cardiac, vascular, pulmonary, renal, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric disturbances.
- Patients with history of myopathies or evidence of active muscle disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Division Of Endocrinology & Diabetes, Medanta The Medicity
Gurgaon, Haryana, 122001
Surender, PhD, 01244141414 ext. 6596, yadavsurender89@gmail.com
Mohammad Shafi Kuchay, MBBS, MD,DM, 01244141414 ext. 6596, drshafikuchay@gmail.com
About this study
Official title: Effect of Oral Semaglutide on Liver Fat and Body Composition in Liver Transplant Recipients With Diabetes Mellitus: Sema-Lit
Nonalcoholic fatty liver disease (NAFLD) is a spectrum of liver conditions ranging from liver steatosis (NAFL), steatohepatitis (NASH), advanced liver fibrosis and ultimately leads to cirrhosis in a significant proportion of individuals. NAFLD is intimately associated with insulin resistance and associated disorders, such as obesity, type 2 diabetes, metabolic syndrome, and dyslipidemia.
It has been noted that several individuals with liver transplantation develop nonalcoholic fatty liver disease in the transplanted liver. This is because of the presence of various risk factors of obesity and NAFLD, such as decreased physical activity, that persist following liver transplantation. Post-liver transplant patients are particularly at risk for developing NAFLD, as these patients are on oral steroids and immunosuppressants for a significant period of time.
There is no medication approved for the prevention or treatment of NAFLD. Semaglutide is an GLP-1 receptor agonist that have been approved for the treatment of type 2 diabetes and obesity. Semaglutide has also been demonstrated to have beneficial effects on NAFLD. However, there is no data on the effect of semaglutide on liver fat accumulation or changes in body composition in patients following liver transplantation. Therefore, the current pilot study is planned to evaluate the effect of oral semaglutide on the liver fat, liver enzymes and body composition in patients undergoing liver transplantation
Read the detailed description
This trial is an investigator initiated, open label, case-control study to examine the effect of oral semaglutide (3mg for 4 weeks; then 7 mg for 20 weeks) once a day for 24 weeks on liver and pancreatic fat content and body composition. Age- and BMI-matched controls will be recruited, who will receive standard care, except for oral semaglutide. Hepatic and pancreatic steatosis will be measured by MRI-proton-density fat fraction (PDFF), a validated quantitative biomarker for liver fat. Body composition parameters will be quantified by DEXA, the gold standard for body composition analysis. The study will be conducted according to the CONSORT guidelines. The patient population for the trial will be derived from Medanta-The Medicity Hospital endocrine and hepatology out-patient clinic, who would primarily visit for management of post-liver transplantation care and diabetes mellitus. The study will be conducted in Medanta-The Medicity Hospital, Gurugram, Haryana, which is a tertiary care center in North India. Patients deemed eligible will be screened for the trial
Study visits
After careful assessment at the baseline visit, participants meeting all inclusion and exclusion criteria will receive oral semaglutide 3 mg once daily empty stomach for 4 weeks, then 7 mg for 20 weeks. Age- and BMI-matched controls will receive standard of care, except for oral semaglutide. Participants will be advised to return to the out-patient endocrine and hepatology/liver transplant clinics for follow-up visits at weeks 12 and 24.
MRI-PDFF protocols
MRI-PDFF for fat quantification
MRI-PDFF is a non-invasive, objective, and quantitative MR imaging-based biomarker that can accurately estimate liver fat. MRI-PDFF has been demonstrated to be a robust technique for assessing treatment response in NASH clinical trials. In this study, the time interval from obtaining the baseline MRI-PDFF to initiating the study drug will be less than one week.
MRI-PDFF for detailed fat mapping of the entire liver
All MR examinations will be done by an experienced MR technologist in the Medanta Radiology department under the direction of the radiologist investigator (SK). The radiologist investigator, blinded to the patients' treatment group allocation, clinical and biochemical data, and order of scans (baseline and follow-up), will perform the image analyses.
ROI colocalization before and after treatment To assess longitudinal changes in liver fat content, one colocalized ROI will be placed in each of the nine liver segments (nine separate ROIs) on the baseline and follow-up MRI examinations.
Sample size calculation We assumed that a 5.0% change in absolute liver fat content between baseline and 24 weeks would be the minimally appreciable and clinically relevant difference. We will recruit 30 patients on a pilot study basis. We will also recruit 20 age- and BMI-matched controls.
Patient confidentiality Precautions will be taken to ensure confidentiality. Data collection forms will not reveal the name of patients included in study. All the participants will be covered by insurance to cover the cost of any untoward effect directly resulting from enrolment in the study.
- Conditions
- Liver Transplant; Complications, Diabete Mellitus
- Being tested
- Semaglutide Pill
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide PillDrug
Patient will receive oral semaglutide
| Study group | Role | What they receive |
|---|---|---|
| Oral Semaglutide | Experimental | Patient will receive oral semaglutide Receives: Drug: Semaglutide Pill |
| Standard of care | No intervention | Patient will receive standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in liver fat content
Quantified by MRI-PDFF
Measured: Baseline to 24 weeks
Secondary outcomes (16)
Change in pancreatic fat content
Measured by DEXA
Measured: Baseline to 24 weeks
Change in body weight
Measured by DEXA
Measured: Baseline to 24 weeks
Change in body mass index
Measured by DEXA
Measured: Baseline to 24 weeks
Change in total fat percentage
Measured by DEXA
Measured: Baseline to 24 weeks
Change in lean muscle mass
Measured by DEXA
Measured: Baseline to 24 weeks
Change in bone mineral content
Measured by DEXA
Measured: Baseline to 24 weeks
Change in controlled attenuation parameter
Measured by transient elastography
Measured: Baseline to 24 weeks
Change in liver stiffness measurement
Measured by transient elastography
Measured: Baseline to 24 weeks
Change in aspartate aminotransferase
Measured: Baseline to 24 weeks
Change in alanine aminotransferase
Measured: Baseline to 24 weeks
Change in gamma-glutamyl transpeptidase
Measured: Baseline to 24 weeks
Change in serum creatinine concentrations
Measured: Baseline to 24 weeks
Change in HbA1c
Measured: Baseline to 24 weeks
Change in triglycerides
Measured: Baseline to 24 weeks
Change in HDL cholesterol
Measured: Baseline to 24 weeks
Change in LDL-cholesterol
Measured: Baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start30 Oct 2023
- Primary completion2 Sep 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Liver Transplant; ComplicationsStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medanta, The Medicity, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Mohammad Shafi Kuchay, Medanta, The Medicity, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060392
- Sponsor's protocol ID
- MMENDO02
- Acronym
- Sema-Lit
- Status last verified
- Jun 2025
- First submitted
- 23 Sep 2023
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Newsome PN, Buchholtz K, Cusi K, Linder M, Okanoue T, Ratziu V, Sanyal AJ, Sejling AS, Harrison SA; NN9931-4296 Investigators. A Placebo-Controlled Trial of Subcutaneous Semaglutide in Nonalcoholic Steatohepatitis. N Engl J Med. 2021 Mar 25;384(12):1113-1124. doi: 10.1056/NEJMoa2028395. Epub 2020 Nov 13.
PubMed 33185364Alkhouri N, Herring R, Kabler H, Kayali Z, Hassanein T, Kohli A, Huss RS, Zhu Y, Billin AN, Damgaard LH, Buchholtz K, Kjaer MS, Balendran C, Myers RP, Loomba R, Noureddin M. Safety and efficacy of combination therapy with semaglutide, cilofexor and firsocostat in patients with non-alcoholic steatohepatitis: A randomised, open-label phase II trial. J Hepatol. 2022 Sep;77(3):607-618. doi: 10.1016/j.jhep.2022.04.003. Epub 2022 Apr 16.
PubMed 35439567Malik SM, Devera ME, Fontes P, Shaikh O, Sasatomi E, Ahmad J. Recurrent disease following liver transplantation for nonalcoholic steatohepatitis cirrhosis. Liver Transpl. 2009 Dec;15(12):1843-51. doi: 10.1002/lt.21943.
PubMed 19938117Reeder SB, Cruite I, Hamilton G, Sirlin CB. Quantitative Assessment of Liver Fat with Magnetic Resonance Imaging and Spectroscopy. J Magn Reson Imaging. 2011 Oct;34(4):729-749. doi: 10.1002/jmri.22775. Epub 2011 Sep 16.
PubMed 22025886Permutt Z, Le TA, Peterson MR, Seki E, Brenner DA, Sirlin C, Loomba R. Correlation between liver histology and novel magnetic resonance imaging in adult patients with non-alcoholic fatty liver disease - MRI accurately quantifies hepatic steatosis in NAFLD. Aliment Pharmacol Ther. 2012 Jul;36(1):22-9. doi: 10.1111/j.1365-2036.2012.05121.x. Epub 2012 May 3.
PubMed 22554256Le TA, Chen J, Changchien C, Peterson MR, Kono Y, Patton H, Cohen BL, Brenner D, Sirlin C, Loomba R; San Diego Integrated NAFLD Research Consortium (SINC). Effect of colesevelam on liver fat quantified by magnetic resonance in nonalcoholic steatohepatitis: a randomized controlled trial. Hepatology. 2012 Sep;56(3):922-32. doi: 10.1002/hep.25731. Epub 2012 Jul 2.
PubMed 22431131Loomba R, Sirlin CB, Ang B, Bettencourt R, Jain R, Salotti J, Soaft L, Hooker J, Kono Y, Bhatt A, Hernandez L, Nguyen P, Noureddin M, Haufe W, Hooker C, Yin M, Ehman R, Lin GY, Valasek MA, Brenner DA, Richards L; San Diego Integrated NAFLD Research Consortium (SINC). Ezetimibe for the treatment of nonalcoholic steatohepatitis: assessment by novel magnetic resonance imaging and magnetic resonance elastography in a randomized trial (MOZART trial). Hepatology. 2015 Apr;61(4):1239-50. doi: 10.1002/hep.27647. Epub 2015 Feb 27.
PubMed 25482832
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Semaglutide on Liver Fat and Body Composition in Liver Transplant Recipients With Diabetes Mellitus: Sema-Lit
- ClinicalTrials.gov ID
- NCT06060392
- Acronym / sponsor ID
- Sema-Lit / MMENDO02
- Conditions
- Liver Transplant; Complications, Diabete Mellitus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medanta, The Medicity, IndiaUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 2 Sep 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 29 Sep 2023 (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.
Nonalcoholic fatty liver disease (NAFLD) is a spectrum of liver conditions ranging from liver steatosis (NAFL), steatohepatitis (NASH), advanced liver fibrosis and ultimately leads to cirrhosis in a significant proportion of individuals. NAFLD is intimately associated with insulin resistance and associated disorders, such as obesity, type 2 diabetes, metabolic syndrome, and dyslipidemia.
It has been noted that several individuals with liver transplantation develop nonalcoholic fatty liver disease in the transplanted liver. This is because of the presence of various risk factors of obesity and NAFLD, such as decreased physical activity, that persist following liver transplantation. Post-liver transplant patients are particularly at risk for developing NAFLD, as these patients are on oral steroids and immunosuppressants for a significant period of time.
There is no medication approved for the prevention or treatment of NAFLD. Semaglutide is an GLP-1 receptor agonist that have been approved for the treatment of type 2 diabetes and obesity. Semaglutide has also been demonstrated to have beneficial effects on NAFLD. However, there is no data on the effect of semaglutide on liver fat accumulation or changes in body composition in patients following liver transplantation. Therefore, the current pilot study is planned to evaluate the effect of oral semaglutide on the liver fat, liver enzymes and body composition in patients undergoing liver transplantation
Detailed description
This trial is an investigator initiated, open label, case-control study to examine the effect of oral semaglutide (3mg for 4 weeks; then 7 mg for 20 weeks) once a day for 24 weeks on liver and pancreatic fat content and body composition. Age- and BMI-matched controls will be recruited, who will receive standard care, except for oral semaglutide. Hepatic and pancreatic steatosis will be measured by MRI-proton-density fat fraction (PDFF), a validated quantitative biomarker for liver fat. Body composition parameters will be quantified by DEXA, the gold standard for body composition analysis. The study will be conducted according to the CONSORT guidelines. The patient population for the trial will be derived from Medanta-The Medicity Hospital endocrine and hepatology out-patient clinic, who would primarily visit for management of post-liver transplantation care and diabetes mellitus. The study will be conducted in Medanta-The Medicity Hospital, Gurugram, Haryana, which is a tertiary care center in North India. Patients deemed eligible will be screened for the trial
Study visits
After careful assessment at the baseline visit, participants meeting all inclusion and exclusion criteria will receive oral semaglutide 3 mg once daily empty stomach for 4 weeks, then 7 mg for 20 weeks. Age- and BMI-matched controls will receive standard of care, except for oral semaglutide. Participants will be advised to return to the out-patient endocrine and hepatology/liver transplant clinics for follow-up visits at weeks 12 and 24.
MRI-PDFF protocols
MRI-PDFF for fat quantification
MRI-PDFF is a non-invasive, objective, and quantitative MR imaging-based biomarker that can accurately estimate liver fat. MRI-PDFF has been demonstrated to be a robust technique for assessing treatment response in NASH clinical trials. In this study, the time interval from obtaining the baseline MRI-PDFF to initiating the study drug will be less than one week.
MRI-PDFF for detailed fat mapping of the entire liver
All MR examinations will be done by an experienced MR technologist in the Medanta Radiology department under the direction of the radiologist investigator (SK). The radiologist investigator, blinded to the patients' treatment group allocation, clinical and biochemical data, and order of scans (baseline and follow-up), will perform the image analyses.
ROI colocalization before and after treatment To assess longitudinal changes in liver fat content, one colocalized ROI will be placed in each of the nine liver segments (nine separate ROIs) on the baseline and follow-up MRI examinations.
Sample size calculation We assumed that a 5.0% change in absolute liver fat content between baseline and 24 weeks would be the minimally appreciable and clinically relevant difference. We will recruit 30 patients on a pilot study basis. We will also recruit 20 age- and BMI-matched controls.
Patient confidentiality Precautions will be taken to ensure confidentiality. Data collection forms will not reveal the name of patients included in study. All the participants will be covered by insurance to cover the cost of any untoward effect directly resulting from enrolment in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Semaglutide | Experimental | Drug: Semaglutide PillPatient will receive oral semaglutide |
| Standard of care | No intervention | –Patient will receive standard of care |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A man or woman, 30 years of age or above with liver transplantation of at least 3 months duration who meets all the following two criteria:
- Subjects must be medically stable based on medical history, physical examination, and laboratory investigations.
- Subjects must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
- Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of the study and are willing to participate in the study.
Key exclusion criteria (20 listed)
- History of diabetic ketoacidosis, type 1 diabetes, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy.
- History of brittle or labile glycemic control, with widely varying glucose measurements by FPG or SMBG such that stable glucose control over the treatment period would be unlikely.
- History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 3 years before Screening, or an Alcohol Use Disorders Identification Test (AUDIT) with a score >=8, or alcohol consumption of more than 20 g per day in the case of women and more than 30 g per day in the case of men for at least three consecutive months during the previous 5 years.
- Thyroid stimulating hormone (TSH) value that is either < 0.45 mIU/L or >10 mIU/L at Screening.
- Note: Subjects on thyroid hormone replacement therapy must be on a stable dose and dosing regimen for at least 4 weeks prior to enrollment.
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 |
|---|---|---|
| Semaglutide PillPatient will receive oral semaglutide | Drug | Oral Semaglutide |
Primary outcome
Change in liver fat content
Time frame: Baseline to 24 weeks
Quantified by MRI-PDFF
16 secondary outcomes
Change in pancreatic fat content
Time frame: Baseline to 24 weeks
Change in body weight
Time frame: Baseline to 24 weeks
Change in body mass index
Time frame: Baseline to 24 weeks
Change in total fat percentage
Time frame: Baseline to 24 weeks
Change in lean muscle mass
Time frame: Baseline to 24 weeks
Change in bone mineral content
Time frame: Baseline to 24 weeks
Change in controlled attenuation parameter
Time frame: Baseline to 24 weeks
Change in liver stiffness measurement
Time frame: Baseline to 24 weeks
Change in aspartate aminotransferase
Time frame: Baseline to 24 weeks
Change in alanine aminotransferase
Time frame: Baseline to 24 weeks
Change in gamma-glutamyl transpeptidase
Time frame: Baseline to 24 weeks
Change in serum creatinine concentrations
Time frame: Baseline to 24 weeks
Change in HbA1c
Time frame: Baseline to 24 weeks
Change in triglycerides
Time frame: Baseline to 24 weeks
Change in HDL cholesterol
Time frame: Baseline to 24 weeks
Change in LDL-cholesterol
Time frame: Baseline to 24 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 13 Jun 2025.
- Results publication: PubMed 33185364Newsome PN, Buchholtz K, Cusi K, Linder M, Okanoue T, Ratziu V, Sanyal AJ, Sejling AS, Harrison SA; NN9931-4296 Investigators. A Placebo-Controlled Trial of Subcutaneous Semaglutide in Nonalcoholic Steatohepatitis. N Engl J Med. 2021 Mar 25;384(12):1113-1124. doi: 10.1056/NEJMoa2028395. Epub 2020 Nov 13.
- Results publication: PubMed 35439567Alkhouri N, Herring R, Kabler H, Kayali Z, Hassanein T, Kohli A, Huss RS, Zhu Y, Billin AN, Damgaard LH, Buchholtz K, Kjaer MS, Balendran C, Myers RP, Loomba R, Noureddin M. Safety and efficacy of combination therapy with semaglutide, cilofexor and firsocostat in patients with non-alcoholic steatohepatitis: A randomised, open-label phase II trial. J Hepatol. 2022 Sep;77(3):607-618. doi: 10.1016/j.jhep.2022.04.003. Epub 2022 Apr 16.
- Results publication: PubMed 19938117Malik SM, Devera ME, Fontes P, Shaikh O, Sasatomi E, Ahmad J. Recurrent disease following liver transplantation for nonalcoholic steatohepatitis cirrhosis. Liver Transpl. 2009 Dec;15(12):1843-51. doi: 10.1002/lt.21943.
- Results publication: PubMed 22025886Reeder SB, Cruite I, Hamilton G, Sirlin CB. Quantitative Assessment of Liver Fat with Magnetic Resonance Imaging and Spectroscopy. J Magn Reson Imaging. 2011 Oct;34(4):729-749. doi: 10.1002/jmri.22775. Epub 2011 Sep 16.
- Results publication: PubMed 22554256Permutt Z, Le TA, Peterson MR, Seki E, Brenner DA, Sirlin C, Loomba R. Correlation between liver histology and novel magnetic resonance imaging in adult patients with non-alcoholic fatty liver disease - MRI accurately quantifies hepatic steatosis in NAFLD. Aliment Pharmacol Ther. 2012 Jul;36(1):22-9. doi: 10.1111/j.1365-2036.2012.05121.x. Epub 2012 May 3.
- Results publication: PubMed 22431131Le TA, Chen J, Changchien C, Peterson MR, Kono Y, Patton H, Cohen BL, Brenner D, Sirlin C, Loomba R; San Diego Integrated NAFLD Research Consortium (SINC). Effect of colesevelam on liver fat quantified by magnetic resonance in nonalcoholic steatohepatitis: a randomized controlled trial. Hepatology. 2012 Sep;56(3):922-32. doi: 10.1002/hep.25731. Epub 2012 Jul 2.
- Results publication: PubMed 25482832Loomba R, Sirlin CB, Ang B, Bettencourt R, Jain R, Salotti J, Soaft L, Hooker J, Kono Y, Bhatt A, Hernandez L, Nguyen P, Noureddin M, Haufe W, Hooker C, Yin M, Ehman R, Lin GY, Valasek MA, Brenner DA, Richards L; San Diego Integrated NAFLD Research Consortium (SINC). Ezetimibe for the treatment of nonalcoholic steatohepatitis: assessment by novel magnetic resonance imaging and magnetic resonance elastography in a randomized trial (MOZART trial). Hepatology. 2015 Apr;61(4):1239-50. doi: 10.1002/hep.27647. Epub 2015 Feb 27.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semaglutide Pill in people with Liver Transplant; Complications and Diabete Mellitus, run by Medanta, The Medicity, India 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 6 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 13 Jun 2025. 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. 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?
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?
Contact Mr Surender, PhD (01244141414 ext. 6596, yadavsurender89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in liver fat content (time frame: Baseline to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06060392, which also lists 7 linked publications.
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 13 Jun 2025.