Actively Recruiting
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
Led by Novo Nordisk A/S · Updated on 2026-06-04
48
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of a new medicine called NNC0113-5840 in adults with overweight or obesity. This early phase 1 clinical trial aims to understand how the medicine is tolerated and how it behaves in the body when given in increasing single doses. The study compares NNC0113-5840 to a placebo, which is a treatment without active medicine, to gather clear information on safety. Participants will be randomly assigned to one of several groups receiving different single dose levels of NNC0113-5840 or a matching placebo. The medicine and placebo are given as injections under the skin in the abdominal area using a needle and syringe. There are six dose levels of NNC0113-5840 being tested, each given once during the study. During the trial, participants will be monitored from the day they receive the injection up to 43 days to record any side effects or adverse events. Researchers will also measure how much of the medicine is present in the blood over time and the highest concentration reached. Participants will have medical history reviews, physical exams, vital signs, blood tests, and heart monitoring to ensure safety throughout the study.
CONDITIONS
Brief Title
A Research Study Investigating How a New Medicine NNC0113-5840 Works in People With Overweight or Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female
- Age 18-55 years (inclusive) at the time of informed consent
- Body mass index (BMI) between 25.0 and 34.9 kg/m2 due to excess adipose tissue
- Eligible based on medical history, physical exam, vital signs, ECG, and lab tests at screening and visit 2 (day -1) as judged by investigator
You will not qualify if you...
- Known or suspected allergy to study treatments or related products
- Any medical condition that might risk participant safety or compliance with the study
- Glycosylated hemoglobin (HbA1c) of 6.5% or higher 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.
1 visit (in-person)
Duration - Up to 43 days from dosing
Participants receive a single subcutaneous dose of the study drug or placebo and are monitored for safety and pharmacokinetics.
Multiple visits up to Day 43 for assessments and monitoring
Trial Site Locations
Total: 1 location
1
PAREXEL Glendale/LA EPCU
Glendale, California, United States, 91206
Actively Recruiting
Research Team
N
Novo Nordisk
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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