NNC4005-0001 for Fatty Liver Disease

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Novo Nordisk A/S

Must not be taking: GLP-1 agonists, Pioglitazone

Disqualifiers: MASH therapies, High AST/ALT, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, NNC4005-0001, to determine its safety and tolerance in people with fatty liver disease, particularly those with increased body weight and liver fat. Participants will receive either the treatment or a placebo (a treatment without active medicine) over 7 to 8 months. It suits individuals with a BMI (a measure of body weight) between 27 and 40 and significant liver fat, but no history of certain liver conditions. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Will I have to stop taking my current medications?

The trial requires that you stop using certain medications, such as high-dose vitamin E, GLP-1 agonists, GIP/GLP-1 agonists, or pioglitazone, at least 6 months before joining. If you're on these, you'll need to stop them to participate.

Is there any evidence suggesting that NNC4005-0001 is likely to be safe for humans?

Research is investigating whether NNC4005-0001 is safe for individuals with higher body weight and liver fat. As the study is just beginning, detailed safety information is not yet available. Early studies primarily focus on assessing the safety of a treatment, closely monitoring for any side effects or reactions. If any serious issues arise, the study will halt. This indicates that some initial safety checks have likely been met, but further information is needed for confirmation. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for fatty liver disease, which often focus on lifestyle changes and medications like vitamin E or pioglitazone, NNC4005-0001 is unique because it is administered as a single subcutaneous injection. Researchers are excited about this treatment because it potentially offers a more convenient and less frequent dosing regimen compared to oral medications that need to be taken daily. Additionally, it involves a novel mechanism of action that could target the disease more effectively than current therapies. This innovative approach could lead to improved outcomes for patients with fatty liver disease.

What evidence suggests that NNC4005-0001 might be an effective treatment for fatty liver disease?

Research shows that NNC4005-0001, which participants in this trial may receive, might be a promising treatment for fatty liver disease. This treatment targets individuals with excess body weight and liver fat. Although limited human data exists on NNC4005-0001, it aims to improve liver health. This is crucial because untreated fatty liver disease can lead to more serious liver issues. Early findings suggest that reducing liver fat might enhance overall liver function. As NNC4005-0001 remains under study, further research will help confirm its effectiveness. ^{1 5 6 7 8}

Who Is on the Research Team?

Clinical Transparency' (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

This trial is for adults with a higher body weight and liver fat, indicative of conditions like Nonalcoholic Steatohepatitis or Hepatic Steatosis. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not be on conflicting medications.

Inclusion Criteria

Body Mass Index (BMI) of 27.0-40.0 kg/m^2 at screening process

I am between 18 and 69 years old.

My liver fat level is 8% or higher, confirmed by a recent MRI.

Exclusion Criteria

I have used treatments for liver conditions or fibrosis.

Any condition that might jeopardize participant's safety or compliance with the protocol

AST or ALT levels ≥ 1.5× Upper Limit of Normal at screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single ascending dose of NNC4005-0001 or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• NNC4005-0001
• Placebo

Trial Overview The study tests the safety and tolerability of NNC4005-0001 compared to a placebo in individuals with increased body weight and liver fat. The trial will span approximately 7 to 8 months, where participants randomly receive either the new medicine or an inactive substance.

How Is the Trial Designed?

Group I: NNC4005-0001 Experimental Treatment 1 Intervention

Participants will receive a single dose of NNC4005-0001 injected subcutaneously. Trial will include up to 6 ascending single-dose cohorts.

Group II: Placebo Placebo Group 1 Intervention

Participants in each cohort will receive placebo matched to NNC4005-0001 injected subcutaneously.

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials

1,578

Recruited

3,813,000+

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07214870

A Research Study of a Potential New Medicine (NNC4005 ... The purpose of this clinical study is to find out if NNC4005-0001 is well-tolerated and safe for people who have increased body weight and increased liver fat.

2. tipranks.com tipranks.com/news/company-announcements/novo-nordisks-new-clinical-study-a-potential-breakthrough-in-liver-disease-treatment

Novo Nordisk's New Clinical Study: A Potential ... ' The study aims to assess the safety and tolerability of NNC4005-0001, a potential new treatment for adults with increased body weight and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8919523/

Non-alcoholic fatty liver disease (NAFLD) - PubMed Central Weight loss, dietary modification, and the treatment of underlying metabolic syndrome remain the mainstays of therapy once the diagnosis is established.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10651384/

Nonalcoholic Fatty Liver Disease as a Systemic ... Liver fibrosis, but no other histologic features, is associated with long-term outcomes of patients with nonalcoholic fatty liver disease. Gastroenterology ...

5. mdpi.com mdpi.com/1422-0067/17/5/774

The Natural Course of Non-Alcoholic Fatty Liver Disease In contrast, estimates of progression to cirrhosis in NASH patients varies with 10% developing decompensated liver disease over 13 years [11] and 25% developing ...

6. mayoclinic.org mayoclinic.org/diseases-conditions/nonalcoholic-fatty-liver-disease/symptoms-causes/syc-20354567

Nonalcoholic fatty liver disease - Symptoms and causes Tissue samples show extra fat in nonalcoholic fatty liver disease, while inflammation and advanced scarring are seen in nonalcoholic ...

7. liverfoundation.org liverfoundation.org/liver-diseases/fatty-liver-disease/nonalcoholic-fatty-liver-disease-nafld/

Nonalcoholic Fatty Liver Disease (NAFLD) Nonalcoholic Fatty Liver Disease is the build-up of extra fat in liver cells not caused by alcohol. The severe form is called nonalcoholic ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6334080/

Non-alcoholic fatty liver disease - PMC - PubMed Central - NIH Non-alcoholic fatty liver disease (NAFLD) has a global prevalence of about 25%. Incidence is increasing with rising levels of obesity, type 2 diabetes and ...