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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 72

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in weight

Secondary outcome measures

Change in adiposity

Change in inflammation - C-reactive protein (CRP)

Change in inflammation - adiponectin

+4 more

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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor

698 Previous Clinical Trials

22,884,945 Total Patients Enrolled

7 Trials studying Non-alcoholic Fatty Liver Disease

7,776 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Novo Nordisk A/SIndustry Sponsor

1,514 Previous Clinical Trials

2,415,018 Total Patients Enrolled

18 Trials studying Non-alcoholic Fatty Liver Disease

4,345 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Mohammad S Siddiqui, MDPrincipal InvestigatorVirginia Commonwealth University

2 Previous Clinical Trials

271 Total Patients Enrolled

2 Trials studying Non-alcoholic Fatty Liver Disease

271 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05424003 — Phase 2

Non-alcoholic Fatty Liver Disease Research Study Groups: Semaglutide, Placebo

Non-alcoholic Fatty Liver Disease Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05424003 — Phase 2

Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05424003 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still capacity vacancies in this experimental program?

"As relayed on clinicaltrials.gov, this medical trial is not currently recruiting patients; the listing was initially posted in December 2022 and last modified 18th October of that same year. That said, there are 110 other trials actively enrolling participants at present."

Answered by AI

Are participants older than twenty eligible for this experiment?

"According to the study's selection criteria, applicants must be between 18 and 75 years of age. Simultaneously, 24 studies are available for minors while elderly patients have access to 62 different clinical trials."

Answered by AI

Is this clinical trial open to new participants?

"This clinical trial is searching for 50 individuals that have experienced weight gain between 18 and 75 years of age. To qualify, candidates must be male or female, exhibit normal graft function as determined by their hepatologist/surgeon along with a HbA1c ≥6.5%, agree to provide informed consent, follow VCU protocols for stable immunosuppression post-LT surgery, no longer be hospitalised after LT surgery and tolerate dieting. Additionally, all eligible females must prove non-pregnancy through urine tests and either be surgically sterile or use birth control during the study period if not post-menopausal."

Answered by AI

To what extent can the Semaglutide Pen Injector be hazardous to patients?

"Our team at Power has rated semaglutide pen injector a 2 on the safety scale, as there is evidence confirming its security but not yet any data demonstrating its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Randomized Double Blinded Placebo-Controlled w/Semaglutide to Prevent Weight Gain After Liver Transplant

2024. "Randomized Double Blinded Placebo-Controlled w/Semaglutide to Prevent Weight Gain After Liver Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05424003.

All > Weight Gain