A Research Study Investigating How a New Medicine NNC0113-5840 Works in People With Overweight or Obesity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NNC0113-5840, Placebo.
- Who it may be relevant to
- Registry conditions: Obesity, Overweight. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug NNC0113-5840
NNC0113-5840 will be administered subcutaneously using needle and syringe in a lifted fold of the abdominal skin. - Drug Placebo
Placebo matched to NNC0113-5840 will be administered subcutaneously using needle and syringe in a lifted fold of the abdominal skin.
Primary outcome measures
- Number of treatment emergent adverse events (TEAEs) [Time frame: From time of dosing (day 1) up to day 43]
Secondary outcome measures (2)
- AUC: Area under the NNC0113-5840 plasma concentration time-curve [Time frame: From pre-dose (day 1) up to day 43]
- Cmax: Maximum observed NNC0113-5840 plasma concentration [Time frame: From pre-dose (day 1) up to day 43]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Glycosylated haemoglobin (HbA1c) more than or equal to (≥) 6.5 percent (%) \[48 millimole per mole (mmol/mol)\] at screening.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- PAREXEL Glendale/LA EPCU — Glendale
- PAREXEL Intl - EPCU-Baltimore — Baltimore
Identifiers
NCT: NCT07566390 · NN9695-8150 · U1111-1328-9401