NCT06207877CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Relative change in energy intake during ad libitum lunch, evening meal and snackbox
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
CagriSema
Experimental
Participants will receive dose 1 cagrilintide and dose 2 semaglutide subcutaneously once-weekly (dose escalation period of 16 weeks) during the maintenance period of 5 weeks.
Intervention: Semaglutide (Drug)
Placebo
Active Comparator
Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously once-weekly for 21 weeks.
Intervention: Placebo (Drug)
CagriSema
Experimental
Participants will receive dose 1 cagrilintide and dose 2 semaglutide subcutaneously once-weekly (dose escalation period of 16 weeks) during the maintenance period of 5 weeks.
Intervention: Cagrilintide (Drug)
Outcomes
Primary Outcomes
Relative change in energy intake during ad libitum lunch, evening meal and snackbox
Time Frame: Baseline to Day 156
Measured in percentage (%).
Secondary Outcomes
- Cmax,para, maximum observed paracetamol concentration(Day 1 and Day 155: 0-5 hour after standardised meal)
- Change in energy intake during ad libitum lunch, evening meal and snackbox(Baseline to Day 156)
- Change in amount of food consumed during ad libitum lunch, evening meal and snackbox(Baseline to Day 156)
- AUC0-1h,para, area under the paracetamol concentration-time curve from 0 to 1 hour after start of standardised meal(Day 1 and Day 155: 0-1 hour after standardised meal)
- AUC0-5h,para, area under the paracetamol concentration-time curve from 0 to 5 hours after start of standardised meal(Day 1 and Day 155: 0-5 hour after standardised meal)
- tmax,para, time to maximum observed paracetamol concentration after start of standardised meal(Day 1 and Day 155: 0-5 hour after standardised meal)
- Change in percent energy intake of high fat, sweet food in total ad libitum energy intake in the evening snack box(Baseline to Day 156)
- Change in Control of Eating questionnaire (COEQ): Craving Control score(Baseline to Day 154)
- Change in COEQ: Positive Mood score(Baseline to Day 154)
- Change in COEQ: Craving for Sweets score(Baseline to Day 154)
- Change in COEQ: Craving for Savoury food score(Baseline to Day 154)
- Change in mean postprandial Visual Analogue Scale (VAS) ratings of Hunger(Baseline to Day 156)
- Change in mean postprandial VAS ratings of Fullness(Baseline to Day 156)
- Change in mean postprandial VAS ratings of Satiety(Baseline to Day 156)
- Change in mean postprandial VAS ratings of Prospective food consumption(Baseline to Day 156)
- Change in mean postprandial VAS ratings of Appetite Score(Baseline to Day 156)
- Change in Power of Food questionnaire for Food available score(Baseline to Day 155)
- Change in Power of Food questionnaire for Food present score(Baseline to Day 155)
- Change in Power of Food questionnaire for Food tasted score(Baseline to Day 155)
- Change in Power of Food questionnaire for Composite score(Baseline to Day 155)
- Change in mean score from the Monetary Choice Questionnaire(Baseline to Day 157)
- Change in body weight(Baseline to Day 155)
Investigators
Study Sites (1)
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