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NNC0194-0499 + Semaglutide for Fatty Liver Disease

Phase 2
Waitlist Available
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histological evidence of fibrosis stage 2, 3 or 4 according to the NASH CRN classification based on a central pathologist evaluation of the baseline liver biopsy.
Histological non-alcoholic fatty liver disease (NAFLD) activity score (NAS) greater than or equal to 4 for subjects with F2/F3 or greater than or equal to 3 for subjects with F4 based on a central pathologist evaluation of the baseline liver biopsy. All subjects must have a score of 1 or more in steatosis, lobular inflammation and hepatocyte ballooning.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (week 0) to week 59
Awards & highlights

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).

Who is the study for?
Adults with a certain liver condition called NASH and evidence of liver scarring (fibrosis stages 2-4) can join this study. They must have had a recent biopsy confirming the disease. Pregnant women or those planning pregnancy, heavy drinkers, and people on unstable doses of certain medications are excluded.Check my eligibility
What is being tested?
The trial is testing if two drugs, NNC0194-0499 and semaglutide, can help reduce liver damage in NASH patients when used together or separately compared to placebo injections. Participants will receive weekly injections for about 19 months with regular clinic visits and calls.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, gastrointestinal issues like nausea or diarrhea, potential low blood sugar levels especially in those taking other diabetes medicines, and increased heart rate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver fibrosis is at stage 2, 3, or 4.
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My liver disease score is high enough to meet the trial's requirements.
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I am of legal age in my country to consent to participate in a clinical trial.
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My liver biopsy confirms I have NASH.
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My liver fibrosis is at stage 2, 3, or 4.
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My liver disease score is high enough to meet the trial's requirements.
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My liver fibrosis is at stage 2, 3, or 4.
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My liver disease score is high enough to meet the trial's requirements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (week 0) to week 59
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0) to week 59 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Improvement in liver fibrosis and no worsening of NASH (Yes/No)
Secondary outcome measures
Change in ALT (alanine aminotransferase)
Change in AST (aspartate aminotransferase)
Change in ELF (Enhanced Liver Fibrosis) score
+21 more

Trial Design

10Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: NNC0194-0499 7.5 mg + semaglutide 2.4 mgExperimental Treatment2 Interventions
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.
Group II: NNC0194-0499 30 mg + semaglutide placebo 2.4 mgExperimental Treatment2 Interventions
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.
Group III: NNC0194-0499 30 mg + semaglutide 2.4 mgExperimental Treatment1 Intervention
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.
Group IV: NNC0194-0499 15 mg + semaglutide 2.4 mgExperimental Treatment2 Interventions
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.
Group V: NNC0174-0833 2.4 mg + semaglutide 2.4 mgExperimental Treatment2 Interventions
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.
Group VI: Placebo (NNC0194-0499) 30 mg + semaglutide 2.4 mgActive Control2 Interventions
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.
Group VII: Placebo (NNC0194-0499) 7.5 mg + semaglutide placebo 2.4 mgPlacebo Group2 Interventions
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.
Group VIII: Placebo (NNC0194-0499) 15 mg + semaglutide placebo 2.4 mgPlacebo Group2 Interventions
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.
Group IX: Placebo (NNC0194-0499) 30 mg + semaglutide placebo 2.4 mgPlacebo Group2 Interventions
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.
Group X: Placebo (NNC0174-0833) 2.4 mg + semaglutide placebo 2.4 mgPlacebo Group2 Interventions
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.

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,503 Previous Clinical Trials
2,385,142 Total Patients Enrolled
17 Trials studying Non-alcoholic Fatty Liver Disease
3,673 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S
56 Previous Clinical Trials
44,448 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
1,242 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

NNC0194 0499 50 mg/mL (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05016882 — Phase 2

Frequently Asked Questions

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

In what quantity are medical facilities in this jurisdiction engaging with the trial?

"Currently, 59 healthcare facilities are enrolling participants in this experiment. These medical clinics span from Hershey to Waco and Seattle with many other locations in between. It is advisable that prospective patients select the closest clinic to avoid unnecessary travel if they decide to join the trial."

Answered by AI

What is the highest possible enrollment capacity for this investigation?

"Absolutely. It is clear from the information found on clinicaltrials.gov that this medical trial, which started being advertised on August 31st 2021, is still open for enrollment. 672 individuals must be recruited across 59 sites to complete the study."

Answered by AI

Are investigators accepting new participants into this research project?

"According to the details hosted on clinicaltrials.gov, this medical trial is actively searching for participants. The study was first listed on August 31st 2021 and has recently been updated as of November 10th 2022."

Answered by AI

What medical benefits does Semaglutide 3 mg/mL provide?

"Semaglutide 3 mg/mL is a popular remedy for chronic weight management. It can also work to alleviate the symptoms of patients with comorbidities related to their bodyweight when combined with exercise and calorie-restriction diets."

Answered by AI

What prior experiments have been performed involving Semaglutide 3 mg/mL?

"At present, 58 operational studies are being conducted on Semaglutide 3 mg/mL with 27 of those trials in Phase 3. Predominantly located in Loma Linda, California, there is an abundance of research sites currently running tests for this drug at 3907 different clinics around the world."

Answered by AI

Has the Food and Drug Administration granted its stamp of approval to Semaglutide 3 mg/mL?

"There is some evidence to suggest Semaglutide 3mg/mL's safety, indicating a score of 2. Efficacy data has not been collected as this is currently a Phase 2 trial."

Answered by AI

How does this investigation compare to previous experiments in its field?

"As of now, 58 clinical studies for Semaglutide 3 mg/mL are operating in 772 cities and 55 countries. The initial trial was sponsored by Novo Nordisk A/S in 2018 with 1387 participants taking part until Phase 4 Drug Approval was completed. Since then, 123 trials have concluded their experiments."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Arizona
Texas
Other
How old are they?
18 - 65
What site did they apply to?
Novo Nordisk Investigational Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
1
0

Why did patients apply to this trial?

I am a believer in new science and want my liver in the best shape it can be.
PatientReceived no prior treatments
Have tried meds in past and still have swelling and pain on upper right side.
PatientReceived no prior treatments
I have lost weight and increased my exercise. I would like to try the drug that you are testing.
PatientReceived 1 prior treatment
I would like to contribute to curing fatty liver disease since my family has be ravished by liver cancer.
PatientReceived 1 prior treatment
I want to help advance new medication through research to help the individual such as myself with better and safer treatment.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

What is the pay? How long with the screening visit take?
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Novo Nordisk Investigational Site: < 48 hours
Average response time
  • < 2 Days
~21 spots leftby May 2024