Semaglutide Pen Injector for Weight Gain

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Virginia Commonwealth University, Richmond, VA
Weight Gain+1 More
Semaglutide Pen Injector - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

In this study, semaglutide will be compared to placebo (a look-alike inactive substance, a "sugar pill") to determine if its use will prevent weight gain after liver transplantation (LT). In addition, researchers will be testing to determine if semaglutide prevents the development of Non-Alcoholic Fatty Liver Disease (NAFLD) after transplant through Magnetic Resonance Imaging (MRI) and laboratory results.

Eligible Conditions

  • Weight Gain
  • (NAFLD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Week 72

Baseline to week 72
Change in adiposity
Change in inflammation - C-reactive protein (CRP)
Change in inflammation - adiponectin
Change in insulin resistance
Change in liver fibrosis markers
Change in serum lipid profile
Change in weight
Week 72
Development of NAFLD

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Semaglutide
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

50 Total Participants · 2 Treatment Groups

Primary Treatment: Semaglutide Pen Injector · Has Placebo Group · Phase 2

Semaglutide
Drug
Experimental Group · 1 Intervention: Semaglutide Pen Injector · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 72
Closest Location: Virginia Commonwealth University · Richmond, VA
Photo of virginia commonwealth university 1Photo of virginia commonwealth university 2Photo of virginia commonwealth university 3
2019First Recorded Clinical Trial
2 TrialsResearching Weight Gain
526 CompletedClinical Trials

Who is running the clinical trial?

Novo Nordisk A/SIndustry Sponsor
1,380 Previous Clinical Trials
2,289,916 Total Patients Enrolled
Virginia Commonwealth UniversityLead Sponsor
609 Previous Clinical Trials
342,335 Total Patients Enrolled
1 Trials studying Weight Gain
37 Patients Enrolled for Weight Gain
Mohammad S Siddiqui, MDPrincipal InvestigatorVirginia Commonwealth University
1 Previous Clinical Trials
31 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are male or female, aged 18-75 years, and you received liver transplantation for any indication.
You have diabetes or pre-diabetes.
You are able to provide informed consent.
You are on a calcineurin inhibitor-based immunosuppressive regimen and have had no previous acute rejection episodes.
You are female and not pregnant, not lactating, and surgically sterile or post-menopausal.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.