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Semaglutide for Preventing Weight Gain After Liver Transplant

Phase 2

Recruiting

Led By Mohammad S Siddiqui, MD

Research Sponsored by Virginia Commonwealth University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female age 18-75 years who received LT for any indication (i.e. NASH, hepatitis C, alcohol-induced cirrhosis, autoimmune hepatitis, etc.)

Stable immunosuppression according the VCU (Virginia Commonwealth University) post-LT protocols ** (i.e. calcineurin inhibitors + mycophenolate)

Must not have

Acute cellular rejection

Active treatment with GLP (glucagon-like peptide)-1RA (receptor agonist) or SGLT (sodium-glucose cotransporter)-2 inhibitors at time of screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 72

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Summary

This trial will compare semaglutide to placebo to see if it prevents weight gain and the development of Non-Alcoholic Fatty Liver Disease (NAFLD) after liver transplantation.

Who is the study for?

This trial is for adults aged 18-75 who've had a liver transplant within the last 8-24 weeks. Participants may have diabetes or pre-diabetes, must be able to eat normally, and women must not be pregnant or breastfeeding. Exclusions include those with certain medical conditions like gastroparesis, pancreatitis, specific cancers, severe kidney issues, or uncontrolled diabetic eye problems.

What is being tested?

Researchers are testing if Semaglutide can prevent weight gain and the return of Non-Alcoholic Fatty Liver Disease after liver transplantation by comparing it to a placebo. The study involves monitoring through MRI scans and lab tests to assess effectiveness.

What are the potential side effects?

Semaglutide might cause side effects such as digestive issues (nausea, vomiting), potential risk of thyroid cancer (rare), inflammation of the pancreas (pancreatitis), allergic reactions due to its ingredients, and changes in blood sugar levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 75 years old and have had a liver transplant.

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My immunosuppression medication has been stable following VCU's post-transplant guidelines.

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I have diabetes or pre-diabetes based on my HbA1c levels or medication use.

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I have been discharged from the hospital after liver transplant surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am experiencing acute cellular rejection.

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I am currently taking medication for diabetes that includes GLP-1RA or SGLT-2 inhibitors.

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I have type 1 diabetes confirmed by anti-GAD or a history of ketoacidosis.

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I have a blood clot in the artery to my liver.

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I have stable diabetic eye conditions.

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I have a history of slow stomach emptying.

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I have had pancreatitis before.

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My kidney function is very low.

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I have a history of medullary thyroid cancer or MEN 2 in my family or myself.

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I am not pregnant, nursing, or planning to become pregnant and I use birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 72

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 72

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 72 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in weight

Secondary study objectives

Change in adiposity

Change in inflammation - C-reactive protein (CRP)

Change in inflammation - adiponectin

+4 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SemaglutideExperimental Treatment1 Intervention

Semaglutide administered subcutaneously (under the skin) once weekly. There will be a 20 week lead in period of dose escalation before reaching the target dose of 2.4mg weekly. Semaglutide will then be administered at the maximum tolerated dose for 52 weeks.

Group II: PlaceboPlacebo Group1 Intervention

Placebo administered subcutaneously (under the skin) once weekly.

0 / 14Eligibility criteria met