Overweight, Obesity
Conditions
Brief summary
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).
Interventions
DRUGNNC0487-0111
NNC0487-0111 will be administered subcutaneously.
DRUGPlacebo
Placebo matched to NNC0487-0111 will be administered subcutaneously.
BEHAVIORALLED
A meal plan and meal replacements will be provided by the investigators.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in sleeping metabolic rate (SMR) | Baseline (week 0) to week 12-26 | Measured in kilojoules per day (kJ/day) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 24-hour energy expenditure (EE) | Baseline (week 0) to week 12-26 | Measured in kJ/day. |
| Change in basal metabolic rate (BMR) | Baseline (week 0) to week 12-26 | Measured in kJ/day. |
| Change in resting metabolic rate (RMR) | Baseline (week 0) to week 12-26 | Measured in kJ/day. |
| Change in diet-induced thermogenesis (DIT) | Baseline (week 0) to week 12-26 | Measured in kJ/day. |
Countries
Denmark, Netherlands
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency dept. 2834
Novo Nordisk A/S
Outcome results
None listed