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

What Was Tested

This registered not phased trial tested Semaglutide.

It has been noted that several individuals with liver transplantation develop nonalcoholic fatty liver disease in the transplanted liver.

It had two arms (groups): Oral Semaglutide (experimental) and Standard of care (no intervention).

Patient will receive oral semaglutide.

Patient will receive standard of care.

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

The registry lists 50 planned participants were the target.

It was open to people of any sex aged from 30 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could 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:. 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.

The full record lists 6 inclusion and 19 exclusion criteria; among the exclusions: history of diabetic ketoacidosis, type 1 diabetes, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy; thyroid stimulating hormone (tsh) value that is either \< 0.45 miu/l or \>10 miu/l at screening; use of vitamin e within 4 weeks before screening.

How the Study Was Run

Design: non-randomized, single-group and open-label.

Nothing was hidden in this open-label Semaglutide study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2023-10-30 with completion listed for 2025-09-02.

It ran at 1 site in India.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in liver fat content (time frame: Baseline to 24 weeks).

It also tracked 16 secondary outcomes, for example Change in pancreatic fat content, Change in body weight, Change in body mass index, Change in total fat percentage, Change in lean muscle mass and Change in bone mineral content.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Semaglutide in 50 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.