Semaglutide 3 mg/mL for Nonalcoholic Steatohepatitis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Nonalcoholic Steatohepatitis+2 More
Semaglutide 3 mg/mL - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing if a new drug, NNC0194-0499, in combination with semaglutide, can reduce liver damage in patients with non-alcoholic steatohepatitis (NASH).

Video Summary

Eligible Conditions
  • Nonalcoholic Steatohepatitis
  • Steatohepatitis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Nonalcoholic Steatohepatitis

Study Objectives

1 Primary · 24 Secondary · Reporting Duration: From baseline (week 0) to week 59

Week 52
Change in ALT (alanine aminotransferase)
Change in AST (aspartate aminotransferase)
Change in ELF (Enhanced Liver Fibrosis) score
Body Weight Changes
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)
Fibrosis
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 Progress

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

Other trials for Nonalcoholic Steatohepatitis

Trial Design

10 Treatment Groups

Placebo (NNC0194-0499) 30 mg + semaglutide 2.4 mg
1 of 10
NNC0194-0499 15 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 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

672 Total Participants · 10 Treatment Groups

Primary Treatment: Semaglutide 3 mg/mL · Has Placebo Group · Phase 2

NNC0194-0499 15 mg + semaglutide 2.4 mgExperimental Group · 2 Interventions: Semaglutide 3 mg/mL, NNC0194 0499 50 mg/mL · Intervention Types: Drug, Drug
NNC0194-0499 7.5 mg + semaglutide 2.4 mgExperimental Group · 2 Interventions: Semaglutide 3 mg/mL, NNC0194 0499 50 mg/mL · Intervention Types: Drug, Drug
NNC0194-0499 30 mg + semaglutide placebo 2.4 mgExperimental Group · 2 Interventions: Semaglutide placebo, NNC0194 0499 50 mg/mL · Intervention Types: Drug, Drug
NNC0194-0499 30 mg + semaglutide 2.4 mg
Drug
Experimental Group · 1 Intervention: NNC0194 0499 50 mg/mL · Intervention Types: Drug
NNC0174-0833 2.4 mg + semaglutide 2.4 mgExperimental Group · 2 Interventions: Semaglutide 3 mg/mL, NNC0174 0833 10 mg/mL · Intervention Types: Drug, Drug
Placebo (NNC0194-0499) 30 mg + semaglutide 2.4 mgActiveComparator Group · 2 Interventions: Semaglutide 3 mg/mL, Placebo (NNC0194-0499) · Intervention Types: Drug, Drug
Placebo (NNC0194-0499) 7.5 mg + semaglutide placebo 2.4 mgPlaceboComparator Group · 2 Interventions: Semaglutide placebo, Placebo (NNC0194-0499) · Intervention Types: Drug, Drug
Placebo (NNC0194-0499) 15 mg + semaglutide placebo 2.4 mgPlaceboComparator Group · 2 Interventions: Semaglutide placebo, Placebo (NNC0194-0499) · Intervention Types: Drug, Drug
Placebo (NNC0194-0499) 30 mg + semaglutide placebo 2.4 mgPlaceboComparator Group · 2 Interventions: Semaglutide placebo, Placebo (NNC0194-0499) · Intervention Types: Drug, Drug
Placebo (NNC0174-0833) 2.4 mg + semaglutide placebo 2.4 mgPlaceboComparator Group · 2 Interventions: Semaglutide placebo, NNC0174 0833 placebo · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline (week 0) to week 59

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,390 Previous Clinical Trials
2,292,931 Total Patients Enrolled
Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S
56 Previous Clinical Trials
53,195 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 4 Total Inclusion Criteria

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
The patient has evidence of liver damage based on a pathologist's evaluation of a liver biopsy
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.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 30th, 2021

Last Reviewed: October 31st, 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.

Who else is applying?

What state do they live in?
Texas50.0%
Arizona50.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Novo Nordisk Investigational Site100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%