Semaglutide 3 mg/mL for Nonalcoholic Steatohepatitis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Novo Nordisk Investigational Site, Glendale, AZ
Nonalcoholic Steatohepatitis+2 More
Semaglutide 3 mg/mL - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a combination of 2 medicines can reduce liver damage in people with NASH.

See full description

Eligible Conditions

  • Nonalcoholic Steatohepatitis
  • Non-alcoholic Steatohepatitis

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Semaglutide 3 mg/mL will improve 1 primary outcome and 24 secondary outcomes in patients with Nonalcoholic Steatohepatitis. Measurement will happen over the course of From baseline (week 0) to week 52.

Week 52
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. For subjects with type 2 diabetes
Change in LDL (low density lipoprotein) cholesterol
Change in NASH-CHECK (patient-reported outcome measure for non-alcoholic steatohepatitis)pain
Change in PROMIS (Patient-Reported Outcomes Measurement Information System) Fatigue score
Change in SF-36 (36-item Short Form Survey) bodily pain
Change in free fatty acids
Change in histology-assessed liver collagen proportionate area
Change in inflammation assessed by HsCRP (high sensitivity C-reactive protein)
Change in triglycerides
Improvement in ballooning (Yes/No)
Improvement in inflammation (Yes/No)
Improvement in liver fibrosis (Yes/No)
Improvement in liver fibrosis and no worsening of NASH (Yes/No)
Improvement in steatohepatitis with at least a 2-point reduction in NAS and no worsening of fibrosis (Yes/No)
Improvement in steatosis (Yes/No)
Progression of liver fibrosis (Yes/No)
Relative change in body weight
Resolution of steatohepatitis and improvement in liver fibrosis (Yes/No)
Resolution of steatohepatitis and no worsening of liver fibrosis (Yes/No)
Worsening in steatohepatitis (Yes/No)
Week 59
Number of treatment emergent adverse events (TEAEs)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

10 Treatment Groups

Placebo (NNC0194-0499) 30 mg + semaglutide 2.4 mg
1 of 10
NNC0194-0499 7.5 mg + semaglutide 2.4 mg
1 of 10
NNC0194-0499 30 mg + semaglutide placebo 2.4 mg
1 of 10
NNC0194-0499 15 mg + semaglutide 2.4 mg
1 of 10
NNC0194-0499 30 mg + semaglutide 2.4 mg
1 of 10
NNC0174-0833 2.4 mg + semaglutide 2.4 mg
1 of 10
Placebo (NNC0194-0499) 7.5 mg + semaglutide placebo 2.4 mg
1 of 10
Placebo (NNC0194-0499) 15 mg + semaglutide placebo 2.4 mg
1 of 10
Placebo (NNC0194-0499) 30 mg + semaglutide placebo 2.4 mg
1 of 10
Placebo (NNC0174-0833) 2.4 mg + semaglutide placebo 2.4 mg
1 of 10
Active Control
Experimental Treatment
Non-Treatment Group

This trial requires 672 total participants across 10 different treatment groups

This trial involves 10 different treatments. Semaglutide 3 Mg/mL is the primary treatment being studied. Participants will be divided into 5 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

NNC0194-0499 7.5 mg + semaglutide 2.4 mgEach subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.
NNC0194-0499 30 mg + semaglutide placebo 2.4 mgEach subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.
NNC0194-0499 15 mg + semaglutide 2.4 mgEach subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.
NNC0194-0499 30 mg + semaglutide 2.4 mg
Drug
Each subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.
NNC0174-0833 2.4 mg + semaglutide 2.4 mgEach subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.
Placebo (NNC0194-0499) 30 mg + semaglutide 2.4 mgEach subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.
Placebo (NNC0194-0499) 7.5 mg + semaglutide placebo 2.4 mgEach subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.
Placebo (NNC0194-0499) 15 mg + semaglutide placebo 2.4 mgEach subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.
Placebo (NNC0194-0499) 30 mg + semaglutide placebo 2.4 mgEach subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.
Placebo (NNC0174-0833) 2.4 mg + semaglutide placebo 2.4 mgEach subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline (week 0) to week 59
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from baseline (week 0) to week 59 for reporting.

Closest Location

Novo Nordisk Investigational Site - Glendale, AZ

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:
There is evidence of fibrosis stage 2, 3, or 4 on the liver according to the NASH CRN classification show original
The patient has evidence of liver damage based on a pathologist's evaluation of a liver biopsy show original
Subjects with fatty liver disease (NAFLD) based on a central pathologist evaluation of the baseline liver biopsy must have a score of 4 or more in steatosis, lobular inflammation and hepatocyte ballooning to be eligible. show original
Aged greater than or equal to 18 years at the time of signing informed consent. In Republic of Korea, subjects must be aged greater than or equal to 19 years. In Japan, subjects must be aged greater than or equal to 20 years. In Singapore, subjects must be aged greater than or equal to 21 years.

Patient Q&A Section

What are the signs of nonalcoholic steatohepatitis?

"Some signs of NASH include weight loss, swelling of the abdomen, feeling of fullness after eating meals, and a metallic taste in the mouth or throat and diarrhea. Patients who have signs of steatosis, but have no signs of NASH require further evaluation for the condition." - Anonymous Online Contributor

Unverified Answer

What causes nonalcoholic steatohepatitis?

"In most patients with histological criteria of histologically proven NASH, the cause is most probably dietary, especially fat accumulation within the liver due to obesity of childhood or adolescence." - Anonymous Online Contributor

Unverified Answer

What is nonalcoholic steatohepatitis?

"nonalcoholic steatohepatitis is a condition characterized by both insulin resistance and fatty liver disease. NASH is typically diagnosed in middle-aged women with [type 2 diabetes](https://www.withpower.com/clinical-trials/type-2-diabetes) or diabetes associated with metabolic syndrome." - Anonymous Online Contributor

Unverified Answer

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

"2.6% of people are affected with NAFLD. In the United States, 10 million people will have NAFLD by 2030, a 5% increase relative to the present. This is an increase of 7 million new cases, or a 25% increase in the prevalence over the next 20 years." - Anonymous Online Contributor

Unverified Answer

Can nonalcoholic steatohepatitis be cured?

"Although patients with NASH might in some cases have symptom resolution to diet and activity levels, others never fully recover and most still have disabling comorbidities. Future work is needed to determine whether pharmacologic therapies can modify histologic features and improve outcomes." - Anonymous Online Contributor

Unverified Answer

What are common treatments for nonalcoholic steatohepatitis?

"NASH is commonly diagnosed using imaging and laboratory testing. Treatment is often tailored according to the underlying cause, which may include medications, lifestyle modifications, liver transplantation, and various medical procedures. The American Association for the Study of Liver Disease guidelines have recently changed from a focus on the diagnosis criteria in patients with diabetes to a multidisciplinary approach focused on disease severity, fibrosis progression, and the risk of severe complications." - Anonymous Online Contributor

Unverified Answer

How does semaglutide 3 mg/ml work?

"Semaglutide provided statistically significant improvements on key efficacy parameters in subgroup analysis for improvement in hepatic steatosis and the presence of NASH in patients treated with a dose of semaglutide 3 and 20 mg/ml in both sexes. Recent findings support the safety and efficacy of semaglutide in patients with type II diabetes and hepatic steatosis/ NASH." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating nonalcoholic steatohepatitis?

"Hepatocellular carcinoma continues to be a great problem in patients with NASH. There are no new treatment options in NASH that are widely accepted as standard of care, but some agents may be potential candidates for clinical trials." - Anonymous Online Contributor

Unverified Answer

What does semaglutide 3 mg/ml usually treat?

"For NAFLD patients under the age of 50 years, the current study confirms the superiority of semaglutide 3 mg/ml versus placebo over 8 weeks of treatment, regardless of concurrent metabolic treatment or pre-treatment BMI. While BMI and BMI change independently predicted the response to treatment with semaglutide, baseline LDL in children, and baseline ALT in both sexes may serve as indicators of response that are independent of BMI or BMI change." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of semaglutide 3 mg/ml?

"At least one-quarter of patients receiving semaglutide experienced AEs in this study, and a higher proportion of patients experienced AEs while taking the drug in the longer-term. The most common AEs were (non-serious, excluding those reported with drug use and those that were in the placebo group in this study): constipation (12.6%), abdominal pain (11.3%), hypoglycaemia (10.7%), headache (10.3%), diarrhoea (9.4%) and nausea (8.6%). Patients receiving semaglutide had a more than 2-fold increased risk of diarrhoea compared to matched controls on placebo (1.67; 95% CI 1." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets nonalcoholic steatohepatitis?

"About one in every 11 adults in the United States have nonalcoholic steatohepatitis. Nonalcoholic steatohepatitis is usually diagnosed when someone has symptoms such as steatosis, elevated aminotransferase levels, and normal to slightly elevated serum bilirubin. The average age at which a person with nonalcoholic steatohepatitis gets diagnosed is around 40 years old. Women are diagnosed a little earlier than men." - Anonymous Online Contributor

Unverified Answer

Does nonalcoholic steatohepatitis run in families?

"Genetic factors play an important role in the development of the metabolic syndrome and its components, particularly lipid disorders. Findings from a recent study herein suggest that this entity may be under a genetic control (or in the first rank and with probable major epistatic effect) and suggest the use of the family study methodology in the assessment of their contribution." - Anonymous Online Contributor

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