Clinical trial NCT06207877: A Research Study to Look at How CagriSema Influences Food Intake, Appetite and Emptying of the Stomach in People With Excess Body Weight
Official title: An Investigation of the Effect of Cagrilintide and Semaglutide Combination Treatment(CagriSema) on Energy Intake, Appetite and Gastric Emptying in People With Overweight or Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-01-17
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research study tests if CagriSema influences food intake, appetite and emptying of the stomach in people with excess body weight. Participant will either get CagriSema (active medicine) or placebo (a dummy medicine), which has no effect on the body. The treatment participants get is decided by chance. The study will last for about 32 weeks.


Eligibility criteria: Inclusion Criteria:

* Male or female.
* Aged 18-65 years (both inclusive) at the time of signing 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.
* Body mass index (BMI) equal to or above 27.0 kilograms per meter square (kg/m\^2) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.

Exclusion Criteria:

* Glycated haemoglobin (HbA1C) greater than or equal to (≥) 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 attempts (e.g., participation in a weight reduction program) within 90 days before screening.
* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
* Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions.

Primary outcomes:
measure: Relative change in energy intake during ad libitum lunch, evening meal and snackbox
timeFrame: Baseline to Day 156
Secondary outcomes:
measure: Change in energy intake during ad libitum lunch, evening meal and snackbox
timeFrame: Baseline to Day 156
measure: Change in amount of food consumed during ad libitum lunch, evening meal and snackbox
timeFrame: Baseline to Day 156
measure: AUC0-5h,para, area under the paracetamol concentration-time curve from 0 to 5 hours after start of standardised meal
timeFrame: Day 1 and Day 155: 0-5 hour after standardised meal
measure: AUC0-1h,para, area under the paracetamol concentration-time curve from 0 to 1 hour after start of standardised meal
timeFrame: Day 1 and Day 155: 0-1 hour after standardised meal
measure: Cmax,para, maximum observed paracetamol concentration
timeFrame: Day 1 and Day 155: 0-5 hour after standardised meal
measure: tmax,para, time to maximum observed paracetamol concentration after start of standardised meal
timeFrame: Day 1 and Day 155: 0-5 hour after standardised meal
measure: Change in percent energy intake of high fat, sweet food in total ad libitum energy intake in the evening snack box
timeFrame: Baseline to Day 156
measure: Change in Control of Eating questionnaire (COEQ): Craving Control score
timeFrame: Baseline to Day 154
measure: Change in COEQ: Positive Mood score
timeFrame: Baseline to Day 154
measure: Change in COEQ: Craving for Sweets score
timeFrame: Baseline to Day 154
measure: Change in COEQ: Craving for Savoury food score
timeFrame: Baseline to Day 154
measure: Change in mean postprandial Visual Analogue Scale (VAS) ratings of Hunger
timeFrame: Baseline to Day 156
measure: Change in mean postprandial VAS ratings of Fullness
timeFrame: Baseline to Day 156
measure: Change in mean postprandial VAS ratings of Satiety
timeFrame: Baseline to Day 156
measure: Change in mean postprandial VAS ratings of Prospective food consumption
timeFrame: Baseline to Day 156
measure: Change in mean postprandial VAS ratings of Appetite Score
timeFrame: Baseline to Day 156
measure: Change in Power of Food questionnaire for Food available score
timeFrame: Baseline to Day 155
measure: Change in Power of Food questionnaire for Food present score
timeFrame: Baseline to Day 155
measure: Change in Power of Food questionnaire for Food tasted score
timeFrame: Baseline to Day 155
measure: Change in Power of Food questionnaire for Composite score
timeFrame: Baseline to Day 155
measure: Change in mean score from the Monetary Choice Questionnaire
timeFrame: Baseline to Day 157
measure: Change in body weight
timeFrame: Baseline to Day 155
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Parexel International GmbH
Study officials:
affiliation: Novo Nordisk A/S'
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: