Overweight, Obesity
Conditions
Brief summary
The study is testing cagrilintide, a study medicine, to understand how it affects food intake and appetite in people with overweight or obesity. Participants will receive either cagrilintide or placebo, and which treatment participants get is decided by chance. Cagrilintide is the treatment being tested, while placebo looks like the study medicine but does not contain any active medicine. The study will last for about 30 weeks.
Interventions
DRUGCagrilintide
Cagrilintide is administered subcutaneously .
Placebo Cagrilintide is administered subcutaneously.
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
* Male or female (sex at birth). * Age 18-64 years (both inclusive) at the time of signing the informed consent. * Body mass index (BMI) is greater than or equal to (≥) 27.0 kg/m\^2 at screening. Over-weight should be due to excess adipose tissue, as judged by the investigator. * Considered to be generally healthy, except for overweight or obesity, 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.
Exclusion criteria
* Known or suspected hypersensitivity to study intervention(s) or related products. * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method. * Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions. * Glycated haemoglobin (HbA1c) ≥ 6.5% (48 millimoles per mole (mmol/mol)) at screening. * History of type 1 or type 2 diabetes mellitus * Any clinically significant body weight change (≥ 5% self-reported change) or dieting at-tempts (e.g., participation in a weight reduction program) within 90 days before screening. * Use of incretin therapies within the last 6 months prior to screening or previous discontinuation of incretin therapy due to tolerability issues. * 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 6 months prior to screening. * Previous dosing of marketed or non-marketed amylin-based compounds.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative change in total energy intake across ad libitum breakfast, lunch, evening meal and snack box | From baseline (Day 2) to end of treatment (Day 127) | Measured in percentage (%). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in total energy intake across ad libitum breakfast, lunch, evening meal and snack box | From baseline (Day 2) to end of treatment (Day 127) | Measured in kilojoule (kJ). |
| Change in total amount of food consumed across ad libitum breakfast, lunch, evening meal and snack box | From baseline (Day 2) to end of treatment (Day 127) | Measured in grams (g). |
| Absolute change in energy intake of high fat + sweet, high fat + non-sweet, low fat + sweet, low fat + non sweet in the evening snack box | From baseline (Day 2) to end of treatment (Day 127) | Measured in kJ. |
| Change in mean postprandial appetite score (AS) based on Visual Analogue Scale (VAS) | From baseline (Day 1) to end of treatment (Day 126) | Measured in millimetre(mm). VAS appetite questions record the participants' sensations within Hunger, Satiety, Fullness and Prospective food consumption by the participants on a paper printed scale line from 0 to 100 mm. The appetite score will be calculated as \[hunger + (100 - satiety) + (100 - fullness) + prospective food consumption\]/4. Scores of 0 mm are worst and scores of 100 mm are best. |
| Change in mean postprandial VAS ratings of: hunger, fullness, satiety and prospective food consumption | From baseline (Day 1) to end of treatment (Day 126) | Measured in mm. VAS appetite questions record the participants' sensations within Hunger, Satiety, Fullness and Prospective food consumption by the participants on a paper printed scale line from 0 to 100 mm. The appetite score will be calculated as \[hunger + (100 - satiety) + (100 - fullness) + prospective food consumption\]/4. Scores of 0 mm are worst and scores of 100 mm are best. |
| Change in mean postprandial VAS ratings of: visual appearance, taste and overall pleasantness | From baseline (Day 1) to end of treatment (Day 126) | Measured in mm. VAS appeal questions record the participant's sensations within taste, visual appearance and overall pleasantness by the participants on a paper printed scale line from 0 to 100 mm. Scores of 0 mm are worst and scores of 100 mm are best. |
| Change in fasting VAS appetite ratings of: Hunger, fullness, satiety, prospective food consumption and AS | From baseline (Day 1) to end of treatment (Day 126) | Measured in mm. VAS appetite questions record the participant's sensations within Hunger, Satiety, Fullness and Prospective food consumption by the participants on a paper printed scale line from 0 to 100 mm. The appetite score will be calculated as \[hunger + (100 - satiety) + (100 - fullness) + prospective food consumption\]/4. Scores of 0 mm are worst and scores of 100 mm are best. |
| • Change in mean Control of Eating questionnaire (CoEQ), domain: Craving Control score, positive mood score, craving for sweets score, craving for Savory food score | From baseline (Day -1) to end of treatment (Day 125) | Measured in score points. The COEQ is a self-reported measure assessing various aspects of eating behaviour and related psychological factors. The COEQ has 19 different questions designed to assess the intensity and type of food cravings, as well as subjective sensations of appetite and mood. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control (0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); Higher score represents a greater level of Craving Control. |
| Change in mean Power of Food questionnaire for: food available score, food present score, food tasted score, composite score | From baseline (Day -1) to end of treatment (Day 125) | Measured in score points. The power of food questionnaire measures three factors that correspond to different levels of food proximity and reflect responsiveness to food-abundant environments: food available (food that is available, but not physically present), food present (food that is present, but not tasted), and food tasted (food that is tasted, but not consumed). Moreover, an aggregate score is calculated as the mean of the three subdomains. The questionnaire consists of 15 questions, and the participants will be asked to rate their agreement or disagreement with each statement on a 5-point scale (ranging from "strongly disagree" to "strongly agree"). |
Countries
Germany
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency' (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed