Actively Recruiting

Phase Not Applicable
Age: 30Years +
All Genders
ID06060392

Effect of Oral Semaglutide on Liver Fat and Body Composition in Liver Transplant Recipients With Diabetes Mellitus: Sema-Lit

Led by Medanta, The Medicity, India · Updated on 2025-06-13

50

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Nonalcoholic fatty liver disease (NAFLD) includes a range of liver problems from fat buildup to severe scarring and cirrhosis. It is closely linked to insulin resistance and conditions like obesity, type 2 diabetes, metabolic syndrome, and abnormal cholesterol levels. Some people who have had a liver transplant develop NAFLD in their new liver, partly due to ongoing risk factors such as reduced physical activity and the use of steroids and immunosuppressants after transplantation. Currently, no medication is approved specifically for preventing or treating NAFLD in this group. This study is an open-label case-control trial investigating the effects of oral semaglutide, a drug approved for diabetes and obesity, on liver fat, liver enzymes, and body composition in liver transplant recipients with diabetes. Participants will take semaglutide daily, starting with 3 mg for 4 weeks, then 7 mg for 20 weeks. A control group matched by age and body mass index will receive standard care without semaglutide. Liver and pancreatic fat will be measured using MRI-proton-density fat fraction (PDFF), and body composition will be assessed by DEXA scans. Participants will be evaluated at the start and then at 12 and 24 weeks. The study will monitor changes in liver fat, pancreatic fat, body weight, body mass index, fat percentage, muscle mass, bone mineral content, liver stiffness, and various blood markers including liver enzymes and cholesterol. MRI scans will be analyzed by blinded radiologists to ensure accuracy. The total study duration for each participant is 24 weeks, with careful data protection and insurance coverage for any adverse effects during the trial.

CONDITIONS

Brief Title

Effect of Oral Semaglutide on Liver Fat and Body Composition in Liver Transplant Recipients With Diabetes Mellitus

Who Can Participate

Age: 30Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 30 years or above
  • Liver transplantation performed at least 3 months prior
  • Diagnosed with diabetes mellitus managed with metformin and/or insulin with HbA1c ≤9% at screening
  • Body mass index (BMI) greater than 25 kg/m2
  • Medically stable based on medical history, physical exam, and lab tests
  • Willing and able to follow study restrictions
  • Able to provide informed consent indicating understanding and willingness to participate
Not Eligible

You will not qualify if you...

  • History of diabetic ketoacidosis, type 1 diabetes, pancreas or beta-cell transplantation, or diabetes due to pancreatitis or pancreatectomy
  • Unstable or widely varying blood sugar control making stable treatment unlikely
  • Drug or alcohol abuse within past 3 years or high alcohol consumption (over 20 g/day for women, 30 g/day for men) for at least 3 months in last 5 years
  • Abnormal thyroid stimulating hormone (TSH) levels outside 0.45 to 10 mIU/L unless stable on hormone replacement
  • Use of PPAR-γ agonists, SGLT2 inhibitors, or GLP-1 receptor agonists within 12 weeks before enrollment
  • Current eating disorder or significant weight change (±5%) within 12 weeks before screening
  • Recent serious heart or vascular events or severe heart disease
  • Use of vitamin E within 4 weeks before screening
  • Prior major upper gastrointestinal surgery including bariatric procedures
  • History of diabetic gastroparesis or serious gastrointestinal disorders
  • Poor kidney function with eGFR <45 mL/min/1.73 m2
  • Presence of metallic materials or contraindication for MRI
  • Claustrophobia or anxiety preventing MRI participation
  • Significant blood disorders at screening
  • Positive HIV antibody test
  • Contraindications to oral semaglutide
  • Pregnancy, breastfeeding, or planning pregnancy during study
  • Significant cardiac, vascular, pulmonary, renal, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or psychiatric conditions
  • History or signs of muscle disease or myopathies

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 24 weeks

Participants receive oral semaglutide once daily, starting with 3 mg for 4 weeks followed by 7 mg for 20 weeks, to assess effects on liver fat and body composition.

1 baseline visit and 2 follow-up visits at weeks 12 and 24

Trial Site Locations

Total: 1 location

1

Division Of Endocrinology & Diabetes, Medanta The Medicity

Gurgaon, Haryana, India, 122001

Actively Recruiting

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Research Team

M

Mr Surender, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Safety and efficacy of combination therapy with semaglutide, cilofexor and firsocostat in patients with non-alcoholic steatohepatitis: A randomised, open-label phase II trial.

Naim Alkhouri, Robert Herring, Heidi Kabler...

https://pubmed.ncbi.nlm.nih.gov/35439567

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.

Z Permutt, T-A Le, M R Peterson...

https://pubmed.ncbi.nlm.nih.gov/22554256

Effect of colesevelam on liver fat quantified by magnetic resonance in nonalcoholic steatohepatitis: a randomized controlled trial.

Thuy-Anh Le, Joshua Chen, Christopher Changchien...

https://pubmed.ncbi.nlm.nih.gov/22431131

Ezetimibe for the treatment of nonalcoholic steatohepatitis: assessment by novel magnetic resonance imaging and magnetic resonance elastography in a randomized trial (MOZART trial).

Rohit Loomba, Claude B Sirlin, Brandon Ang...

https://pubmed.ncbi.nlm.nih.gov/25482832