A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NNC4005-0001 in Adults

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 69
Healthy Volunteers: f
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• 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/m\^2) (both inclusive) at screening process.

• Hepatic fat fraction greater than or equal to (≥) 8% by magnetic resonance imaging proton density fat fraction (MRI-PDFF) within 17 days prior to dosing.

• No prior or present clinical history of metabolic dysfunction-associated steatohepatitis (MASH) diagnosis.

Locations
Other Locations
Canada
Altasciences
RECRUITING
Montreal
Contact Information
Primary
Novo Nordisk
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Time Frame
Start Date: 2025-10-08
Estimated Completion Date: 2027-05-14
Participants
Target number of participants: 60
Treatments
Experimental: NNC4005-0001
Participants will receive a single dose of NNC4005-0001 injected subcutaneously. Trial will include up to 6 ascending single-dose cohorts.
Placebo_comparator: Placebo
Participants in each cohort will receive placebo matched to NNC4005-0001 injected subcutaneously.
Related Therapeutic Areas
Sponsors
Leads: Novo Nordisk A/S

This content was sourced from clinicaltrials.gov