Semaglutide for Nonalcoholic Steatohepatitis

Phase-Based Estimates
2
Effectiveness
3
Safety
Novo Nordisk Investigational Site, Bern, Switzerland
Nonalcoholic Steatohepatitis+2 More
Semaglutide - Drug
Eligibility
18+
All Sexes
Eligible conditions
Nonalcoholic Steatohepatitis

Study Summary

Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH)

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Eligible Conditions

  • Nonalcoholic Steatohepatitis
  • Non-alcoholic Fatty Liver Disease
  • Fatty Liver
  • Non-alcoholic Steatohepatitis

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Compared to trials

Study Objectives

This trial is evaluating whether Semaglutide will improve 3 primary outcomes and 27 secondary outcomes in patients with Nonalcoholic Steatohepatitis. Measurement will happen over the course of From randomisation (week 0) to week 72.

Week 240
Change in body weight
Improvement in liver fibrosis and no worsening of steatohepatitis (Yes/No)
Part 2: Time to first liver-related clinical event (composite endpoint)
Resolution of steatohepatitis and no worsening of liver fibrosis (Yes/No)
Time to first MACE(Major Adverse Cardiovascular event ) (composite endpoint)
Time to first major cardio-hepatic event (composite endpoint)
Week 72
Change in ALT (alanine aminotransferase)
Change in AST (aspartate aminotransferase)
Change in ELF (Enhanced Liver Fibrosis) score
Change in HDL (High density lipoprotein ) cholesterol
Change in HbA1c (glycated haemoglobin)
Change in LDL (low-density lipoprotein) cholesterol
Change in SF-36 (Short Form 36) Bodily Pain
Change in free fatty acids
Change in histology-assessed liver collagen proportionate area
Change in inflammation assessed by hsCRP (High Sensitive C-Reactive Protein)
Change in liver stiffness assessed by FibroScan®
Change in triglyceride
Changes in NASH-CHECK Pain
Changes in SF-36 (Short Form 36 v2.0 acute ) Physical Component Summary
Changes in SF-36 Mental Component Summary
Improvement in histology-assessed ballooning (Yes/No)
Improvement in histology-assessed inflammation (Yes/No)
Improvement in histology-assessed steatosis (Yes/No)
Improvement in steatohepatitis with at least a 2-point reduction in NAS and no worsening of fibrosis (Yes/No)
Part 1: Improvement in liver fibrosis and no worsening of steatohepatitis (Yes/No)
Part 1: Resolution of steatohepatitis and no worsening of liver fibrosis (Yes/No)
Progression of liver fibrosis (Yes/No)
Resolution of steatohepatitis and improvement in liver fibrosis (Yes/No)
Worsening in steatohepatitis (Yes/No)

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Compared to trials

Side Effects for

Overall Study
Nausea
21%
Decreased Appetite
12%
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT04189848) in the Overall Study ARM group. Side effects include: Nausea with 21%, Decreased Appetite with 12%.

Trial Design

2 Treatment Groups

Placebo
Semaglutide OW (once weekly )
Placebo group

This trial requires 1200 total participants across 2 different treatment groups

This trial involves 2 different treatments. Semaglutide is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Semaglutide OW (once weekly )
Drug
Semaglutide administrated subcutaneously once weekly
Placebo
Drug
Placebo administrated subcutaneously once weekly
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from randomisation (week 0) to week 240
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from randomisation (week 0) to week 240 for reporting.

Closest Location

Novo Nordisk Investigational Site - Pittsburgh, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You have histological evidence of non-alcoholic steatohepatitis based on a central pathologist evaluation of the baseline liver biopsy. show original
Age above or equal to 18 years at the time of signing informed consent.
A histological NAS (Non-alcoholic fatty liver disease Activity Score) above or equal to 4 with a score of 1 or more in steatosis, lobular inflammation and hepatocyte ballooning based on a central pathologist evaluation of the baseline liver biopsy.
You have a histological evidence of fibrosis stage 2 or stage 3 according to the NASH CRN (Clinical Research Network) classification based on a central pathologist evaluation of the baseline liver biopsy. show original

Patient Q&A Section

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

What are the signs of nonalcoholic steatohepatitis?

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In NAFLD, an abnormal blood lipid profile is a strong predictor for NASH. In particular, triglycerides are an important marker of NASH among patients with NAFLD. Metabolic syndrome and other factors are also associated with NASH. The combination of abnormal blood lipids and metabolic syndrome is associated with an increased risk of cirrhosis in men and NAFLD in women.

Unverified Answer

How many people get nonalcoholic steatohepatitis a year in the United States?

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Nonalcoholic steatohepatitis affects approximately 2.4% of the U.S. population. The average rate in the United States is about 1.7% of the population. Men and women are affected equally. The highest incidence of disease is found in the 50 to 60-year-old age group in the United States and in Caucasians.

Unverified Answer

What causes nonalcoholic steatohepatitis?

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Obesity may be the most important cause of steatosis and NASH. steatosis often precedes NASH, but NASH may cause steatosis. Steatosis is more important than insulin resistance as the cause of NASH; insulin resistance does not explain why only 10% of people with normal cholesterolesters develop NASH.

Unverified Answer

What is nonalcoholic steatohepatitis?

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To summarize, NASH often progresses towards cirrhosis; individuals with NASH may also develop liver cancer due to prolonged and severe inflammation, which can result in severe liver damage. Furthermore, patients with NASH have an increased risk for developing cirrhosis, hepatocellular carcinoma, and type 2 diabetes compared to the general population. To identify individuals at risk of NASH, clinicians need to be aware of the following factors: duration and severity of alcohol use; BMI; presence of metabolic syndrome abnormalities; triglyceride levels; fasting free fatty acid levels; liver damage on imaging studies; and markers of insulin resistance.

Unverified Answer

What are common treatments for nonalcoholic steatohepatitis?

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While treatment may be less common, several studies that are in aggregate indicate that nonalcoholic steatohepatitis responds well to weight loss with or without medication and that the effects are usually sustained over many months or years.

Unverified Answer

Can nonalcoholic steatohepatitis be cured?

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Findings from a recent study provides data that suggest the presence of a subgroup of patients with NASH in whom long-term disease remission can be achieved. In some cases, it is possible for patients to achieve a great improvement, even a clinical and histological remission of the NASH pattern. Prospective studies involving larger samples and longer follow-up are needed to confirm these preliminary results.

Unverified Answer

Have there been other clinical trials involving semaglutide?

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We expect that semaglutide is an effective and safe treatment in NAFLD patients with a body mass index level ≥30 kg/m(2), as proven by previous studies.

Unverified Answer

What are the latest developments in semaglutide for therapeutic use?

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Semaglutide is being studied in several Phase I and II clinical trials in patients with various types of diabetes, as well as patients with chronic kidney disease and advanced non-alcoholic steatohepatitis. These studies will be critical to define the role of semaglutide in patients with end organ disease, including renal and liver, and in patients with diabetes with and without comorbidities.

Unverified Answer

Is semaglutide typically used in combination with any other treatments?

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Clinicians might find using semaglutide in combination with other agents used in the treatment of diabetes a useful strategy to reduce the risk of hepatic failure. It is unclear whether this interaction is statistically significant.

Unverified Answer

How does semaglutide work?

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semaglutide is effective in the treatment of obesity in both short-acting and long-acting forms. With semaglutide, significant and durable weight loss was observed after 20 weeks of treatment. In addition to weight loss, decreased serum triglycerides, improved lipid profiles, and increase in HOMA-IR are also observed. The increased adiponectin may also result in improvement in glycemic control.

Unverified Answer

Have there been any new discoveries for treating nonalcoholic steatohepatitis?

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In order to develop effective therapy for NASH, more large trials will be needed in the near future. One of the important obstacles to developing a therapy is that NASH can be developed in different ways. The definition of the disease will also become clearer. Because most of the treatments have been used for other diseases, one needs to further investigate more targeted therapies to treat NASH.

Unverified Answer

What is the primary cause of nonalcoholic steatohepatitis?

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[Among people with nonalcoholic steatohepatitis, fat is not the driving factor in the development of nonalcoholic steatohepatitis. A significant percentage of patients meet the criteria for metabolic syndrome, underscoring the significant contribution that metabolic syndrome has to the development of nonalcoholic steatohepatitis] Liver cancer accounts for about 5% of new cases during the second year after the diagnosis of nonalcoholic steatohepatitis. However, the cause of nonalcoholic steatohepatitis-associated hepatic cancer is not known, even among patients with the known risk factors.

Unverified Answer
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