Semaglutide 3 mg/mL for Nonalcoholic Steatohepatitis

Phase-Based Progress Estimates

Effectiveness

Safety

Nonalcoholic Steatohepatitis+2 More

Semaglutide 3 mg/mL - Drug

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Eligibility

Any Age

All Sexes

What conditions do you have?

Select

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

Miricorilant Dose Escalation

15 mg CBL-514 per injection

TERN-501

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

Miricorilant Dose Escalation

15 mg CBL-514 per injection

TERN-501

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 - 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.