Obesity
Conditions
Brief summary
The purpose of this clinical study is to look at if/how much NNC0487-0111 affects food intake, appetite and metabolism in participants with obesity when compared to placebo. There are 2 study treatments in this study. Participants will inject the study treatment under the skin of your stomach once a week. Participants will get either NNC0487-0111 (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants will get is decided by chance.
Interventions
DRUGNNC0487-0111
NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors into a skin fold on the abdomen.
Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors into a skin fold on the abdomen.
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 64 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Male or female (sex at birth). * Age 18-64 years (both inclusive) at the time of signing the informed consent. * 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, as judged by the investigator. * Overweight should be due to excess adipose tissue, as judged by the investigator. Key
Exclusion criteria
* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method. * History of type 1 or type 2 diabetes mellitus. * Glycated hemoglobin (HbA1c) ≥ 6.5 percent (%) (48 millimole per mole \[mmol/mol\]) at 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 issues. * Any clinically significant body weight change (≥5 % self-reported change) or dieting attempts (e.g., participation in a weight reduction program) within 90 days before screening. * Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 126 | From Baseline to Day 126 | Measured as percentage change of energy. |
| Relative change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 182 | From Baseline to Day 182 | Measured as percentage change of energy. |
| Relative change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 238 | From Baseline to Day 238 | Measured as percentage change of energy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 126 | From Baseline to Day 126 | Measured as kilojoules (kJ). |
| Change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 182 | From Baseline to Day 182 | Measured as kJ. |
| Change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 238 | From Baseline to Day 238 | Measured as kJ. |
| Change from baseline in total amount of food consumed across ad libitum breakfast, lunch, evening meal and snack box to Day 126 | From Baseline to Day 126 | Measured as grams. |
| Change from baseline in total amount of food consumed across ad libitum breakfast, lunch, evening meal and snack box to Day 182 | From Baseline to Day 182 | Measured as grams. |
| Change from baseline in total amount of food consumed across ad libitum breakfast, lunch, evening meal and snack box to Day 238 | From Baseline to Day 238 | Measured as grams. |
| Relative change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 378 | From Baseline to Day 378 | Measured as percentage change of energy. |
| Change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box at Day 378 | From Baseline to Day 378 | Measured as kJ. |
| Change from baseline in total amount of food consumed during ad libitum breakfast, lunch, evening meal and snack box to Day 378 | From Baseline to Day 378 | Measured as grams. |
| Change from baseline in energy intake of high fat, sweet food during ad libitum energy intake in the evening snack box to Day 126 | From Baseline to Day 126 | Measured as kJ. |
| Change from baseline in energy intake of high fat, sweet food during ad libitum energy intake in the evening snack box to Day 182 | From Baseline to Day 182 | Measured as kJ. |
| Change from baseline in energy intake of high fat, sweet food during ad libitum energy intake in the evening snack box to Day 238 | From Baseline to Day 238 | Measured as kJ. |
| Change from baseline in energy intake of high fat, sweet food during ad libitum energy intake in the evening snack box to Day 378 | From Baseline to Day 378 | Measured as kJ. |
| Relative change from Day 19 in body weight to Day 131 | From Day 19 to Day 131 | Measured as percentage change of body weight. |
| Relative change from Day 19 in body weight to Day 187 | From Day 19 to Day 187 | Measured as percentage change of body weight. |
| Relative change from Day 19 in body weight to Day 243 | From Day 19 to Day 243 | Measured as percentage change of body weight. |
| Relative change from Day 19 in body weight to Day 383 | From Day 19 to Day 383 | Measured as percentage change of body weight. |
Countries
Germany
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed