A First-in-human Research Study on How NNC0721-8060 Works in People Living With Overweight or Obesity
A Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0721-8060 in Healthy Adult Participants Living With Overweight or Obesity
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 55 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether NNC0721-8060 is safe and how it works. It is the first study of this drug in humans and is for adults ages 18–55 living with overweight or obesity.
The purpose of the study is to find out if NNC0721-8060 is safe and how it works in people living with overweight or obesity.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Male or female, based on sex at birth.
- Age 18–55 when signing the form to agree to join.
- BMI of 27.0–34.9 at screening. BMI is a measure based on height and weight. The study doctor must judge that extra weight is due to extra body fat.
- The study doctor must decide you can join based on your health history, exam, vital signs, heart electrical test, and lab tests.
Who can't join
- Known or suspected allergy to the study drug or related products.
- Previously assigned to a treatment group in this study.
- Past allergies other than seasonal allergies, or any past severe allergic reaction called anaphylaxis.
- Pregnant, breastfeeding, planning to become pregnant, or able to become pregnant but not using adequate birth control.
- Currently signed up for another study that tests a treatment or other health intervention.
- Received an experimental drug too recently before screening: within 30 days or five half-lives, whichever is longer. A half-life is the time it takes for the amount of a drug in the body to drop by half.
- Any condition, unwillingness, or inability that the study doctor thinks could make joining unsafe or keep you from following study rules.
- HbA1c of 6.5% or higher at screening. This blood test measures average blood sugar over time.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Male or female (sex at birth). * Age 18-55 years (both inclusive) at the time of signing informed consent. * Body Mass Index (BMI) 27.0-34.9 kilograms per square metre (kg/m\^2) (both inclusive) at screening, with overweight due to excess adipose tissue as judged by the investigator. * Considered eligible based on medical history, physical examination, vital signs, electrocardiogram and clinical laboratory tests at screening, as judged by the investigator. Exclusion Criteria: * Known or suspected hypersensitivity to study intervention(s) or related products. * Previous randomisation in this study. * History of allergies (with the exception of seasonal allergies) or history of anaphylactic reactions. * Female who is pregnant, breastfeeding, intends to become pregnant, or is of childbearing potential and not using adequate contraception. * Current participation (signed informed consent) in any other interventional clinical study. * Exposure to an investigational medicinal product within 30 days or five half-lives of that product (whichever is longer) before screening. * Any disorder, unwillingness or inability which, in the investigator's opinion, might jeopardise participant safety or compliance with the protocol. * Glycated haemoglobin (HbA1c) greater than or equal to (≥) 6.5 percentage (%) (48 millimoles per mole \[mmol/mol\]) at screening.
Study sites (2)
KS
- ICON Early Phase Services, LLC · Lenexa, KS 66219More trials in Lenexa
TX
- ICON · San Antonio, TX 78209More trials in San Antonio