A First in Human Dose Study Investigating the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of NNC0113-5840 in Participants With Overweight or Obesity
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 NNC0113-5840 is safe for treating people with excess body weight. There are 2 study treatments in this study, participants will get either NNC0113-5840 (the product being tested) or Placebo (treatment that has no active medicine in it), Which treatment participants get is decided by chance.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:
• Male or female
• Age 18-55 years (both inclusive) at the time of signing the informed consent.
• Body mass index (BMI) between 25.0 and 34.9 kilogram per meter square (kg/m2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
• Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit and visit 2, day -1, as judged by the investigator.
Locations
United States
California
PAREXEL Glendale/LA EPCU
RECRUITING
Glendale
Contact Information
Primary
Novo Nordisk
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Time Frame
Start Date:2026-05-01
Estimated Completion Date:2026-11-26
Participants
Target number of participants:48
Treatments
Experimental: Cohort 1 NNC0113-5840
Participants will be randomized to receive NNC0113-5840 single dose level 1 subcutaneously.
Experimental: Cohort 2 NNC0113-5840
Participants will be randomized to receive NNC0113-5840 single dose level 2 subcutaneously.
Experimental: Cohort 3 NNC0113-5840
Participants will be randomized to receive NNC0113-5840 single dose level 3 subcutaneously.
Experimental: Cohort 4 NNC0113-5840
Participants will be randomized to receive NNC0113-5840 single dose level 4 subcutaneously.
Experimental: Cohort 5 NNC0113-5840
Participants will be randomized to receive NNC0113-5840 single dose level 5 subcutaneously.
Experimental: Cohort 6 NNC0113-5840
Participants will be randomized to receive NNC0113-5840 single dose level 6 subcutaneously.
Placebo_comparator: Placebo matching NNC0113-5840
Participants will receive placebo matched to NNC0113-5840 subcutaneously.