Novo Nordisk A/S
This study will assess the safety, tolerability, the pharmacokinetics from single injection (under the skin) of NNC0581-0001 and explores the pharmacodynamics in healthy participants and participants with hepatic steatosis (increased liver fat). Participants will either get NNC0581-001 or Placebo (dummy treatment). Which treatment participants get is decided by chance.NNC0581-0001 is a new medicine which cannot be prescribed by doctors. The study will last about 58 weeks.
Healthy Volunteers
Hepatic Steatosis
NNC0581-0001
Placebo (NNC0581-0001)
PHASE1
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 48 participants |
Masking : | QUADRUPLE |
Masking Description : | Sponsor staff involved in the clinical trial is masked according to company standard procedures. |
Primary Purpose : | TREATMENT |
Official Title : | A First Human Dose Study Investigating Safety, Tolerability, and Pharmacokinetics of Single Subcutaneous Injections of NNC0581-0001 in Healthy Adults and in Participants With Hepatic Steatosis |
Actual Study Start Date : | 2022-11-23 |
Estimated Primary Completion Date : | 2025-01-22 |
Estimated Study Completion Date : | 2025-08-28 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years to 55 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: | 1 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Parexel CPRU, Level 7
Harrow, Middlesex, United Kingdom, HA1 3UJ