Actively Recruiting
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NNC4005-0001 in Adults
Led by Novo Nordisk A/S · Updated on 2026-02-11
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of a new medicine called NNC4005-0001 in adults who have increased body weight and liver fat, specifically those with fatty liver disease. This early phase 1 clinical trial aims to understand how the medicine behaves in the body and whether it causes any side effects. The study is sponsored by Novo Nordisk A/S and is designed as a randomized, double-blind, placebo-controlled trial to ensure reliable results. Participants will receive a single injection of either NNC4005-0001 or a matching placebo under the skin. The trial includes up to six groups with increasing doses of the medicine to assess its effects at different levels. Each participant will only receive one dose, and the study will monitor them closely for about 7 to 8 months. During the study, participants will have various assessments to track safety and how the medicine is processed in the body. Researchers will record any side effects from the day of dosing until the end of the study visit on day 169. Blood samples will be taken to measure the concentration of the medicine over time, including the highest level reached and how quickly it is cleared from the body. The study involves regular visits and evaluations to ensure participant safety and gather important information about the treatment.
CONDITIONS
Brief 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 (both inclusive) at the time of signing the informed consent.
- Body Mass Index (BMI) of 27.0-40.0 kilogram per square meter (kg/m²) at screening.
- Hepatic fat fraction greater than or equal to 8% 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 jeopardize participant's safety or compliance with the protocol.
- Previous or current use of therapies for MASH or antifibrotic therapies.
- Use of high-dose vitamin E (>800 IU/day), GLP-1 agonists, GIP/GLP-1 agonists, or pioglitazone within 6 months prior to screening.
- Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) levels ≥ 1.5× Upper Limit of Normal (ULN) at screening.
- Total bilirubin levels > 1.5 times ULN if direct bilirubin is within Normal Limits at screening.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single day
Participants receive a single subcutaneous dose of the study drug or placebo in ascending dose cohorts.
1 dosing visit and several follow-up visits up to Day 169
Trial Site Locations
Total: 1 location
1
Altasciences Clinical Company, Inc
Montreal, Quebec, Canada, H3P 3P1
Actively Recruiting
Research Team
N
Novo Nordisk
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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