Actively Recruiting
A Research Study of a Potential New Medicine (NNC4005-0001) for Liver Disease in Adult Participants With Increased Body Weight and Liver Fat
Led by Novo Nordisk A/S · Updated on 2026-02-11
60
Participants Needed
1
Research Sites
83 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. Participants will receive either NNC4005-0001, which is the treatment being tested, or a placebo, which is a treatment that contains no active medicine. The study will last for about for about 7 to 8 months.
CONDITIONS
Official Title
A Research Study of a Potential New Medicine (NNC4005-0001) for Liver Disease in Adult Participants With Increased Body Weight and Liver Fat
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18-69 years at the time of signing informed consent
- Body Mass Index (BMI) of 27.0-40.0 kg/m² at screening
- Hepatic fat fraction of 8% or higher by MRI-PDFF within 17 days prior to dosing
- No prior or current diagnosis of metabolic dysfunction-associated steatohepatitis (MASH)
You will not qualify if you...
- Any condition that might risk participant safety or protocol compliance
- Previous or current use of therapies for MASH or antifibrotic treatments
- Use of high-dose vitamin E (>800 IU/day), GLP-1 agonists, GIP/GLP-1 agonists, or pioglitazone within 6 months prior to screening
- AST or ALT levels ≥ 1.5 times the upper limit of normal at screening
- Total bilirubin levels > 1.5 times upper limit of normal if direct bilirubin is normal at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Altasciences Clinical Company, Inc
Montreal, Quebec, Canada, H3P 3P1
Actively Recruiting
Research Team
N
Novo Nordisk
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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