A Research Study to See How NNC0487-0111 Affects the Body's Energy Use After a Weight Loss in Adults Living With Obesity, Compared to a Low-calorie Diet or Placebo
Recruiting · NCT07757087 · Interventional (participants receive a specific treatment) · Lead sponsor: Novo Nordisk A/S
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The purpose of this clinical study is to evaluate how NNC0487-0111 affects the amount of energy the body uses in people living with obesity following weight loss. This will be compared with the amount of energy used by participants who achieve weight loss through a low-calorie diet and by participants receiving placebo (without weight loss).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Male or female (sex assigned at birth, inclusive of all gender identities).
- Age 18 years or older at the time of signing the informed consent.
Exclusion criteria
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
- Exposure to an investigational medicinal product before screening.
- Any condition, or disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Anticipated change in lifestyle (e.g., eating, exercise or sleeping pattern) during the study, for example, an imminent job change to/from a physically demanding occupation.
- Claustrophobia or severe discomfort of being confined in small rooms.
- History of type 1 or type 2 diabetes mellitus.
- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal (GI), or endocrinological conditions.
- Unusual meal habits (including, but not limited to, eating disorders) and special diet requirements or unwillingness to eat the food provided in the study.
- Use of any weight lowering pharmacotherapy or pharmacotherapy that may cause weight gain, including systemic corticosteroids (except for a short course of treatment, i.e., 7-10 days), tri-cyclic antidepressants, atypical antipsychotic and mood stabilisers prior to screening.
- Use of incretin or amylin-based therapies prior to screening or previous discontinuation of long-term incretin and/or amylin-based therapy due to tolerability issue.
- Physical activity of moderate to vigorous intensity for greater than (\>) 4 hours/week within the past 6 months before screening.
Where it is running
2 locations listed.
- Aarhus Universitetshospital, Steno Diabetes Center Aarhus - Aarhus N, Denmark
- Maastricht University-NUTRIM-Dep Human Biology-Obesity - Maastricht, Netherlands