DRUG
Cagrilintide
Cagrilintide will be administered subcutaneously.
A Research Study to Look at How CagriSema Influences Food Intake, Appetite and Emptying of the Stomach in People With Excess Body Weight
Status
Completed
Phase
Phase 1
Enrollment
62
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
Semaglutide
Semaglutide will be administered subcutaneously.
DRUG
Placebo
Placebo will be administered subcutaneously.
Timeline
From registration to results.
First posted
Jan 17, 2024
Study start
Feb 23, 2024
Primary completion
Oct 16, 2024
Study completion
Nov 22, 2024
Results posted
Not reported
Registry updated
Jan 8, 2026
Outcomes
What the study measures.
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
Change in energy intake during ad libitum lunch, evening meal and snackbox
Time frame · Baseline to Day 156
Measured in kilojoule (KJ).
Change in amount of food consumed during ad libitum lunch, evening meal and snackbox
Time frame · Baseline to Day 156
Measured in grams (g).
AUC0-5h,para, area under the paracetamol concentration-time curve from 0 to 5 hours after start of standardised meal
Time frame · Day 1 and Day 155: 0-5 hour after standardised meal
Measured in hour\*milligram per milliliter ( h\*mg/mL).
AUC0-1h,para, area under the paracetamol concentration-time curve from 0 to 1 hour after start of standardised meal
Time frame · Day 1 and Day 155: 0-1 hour after standardised meal
Measured in h\*mg/mL.
Cmax,para, maximum observed paracetamol concentration
Time frame · Day 1 and Day 155: 0-5 hour after standardised meal
Measured in microgram per milliliter (µcg/mL).
tmax,para, time to maximum observed paracetamol concentration after start of standardised meal
Time frame · Day 1 and Day 155: 0-5 hour after standardised meal
Measured in hours (h).
Change in percent energy intake of high fat, sweet food in total ad libitum energy intake in the evening snack box
Time frame · Baseline to Day 156
Measured in %-point.
Change in Control of Eating questionnaire (COEQ): Craving Control score
Time frame · Baseline to Day 154
The Control of Eating Questionnaire (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 COEQ: Positive Mood score
Time frame · Baseline to Day 154
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 COEQ: Craving for Sweets score
Time frame · Baseline to Day 154
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.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Sex
- ALL
- 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.
Study locations
1 registered sites.
Germany. Showing up to 24 locations stored in the fast local snapshot.
Parexel International GmbH
Berlin, Germany
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Cagrilintide.
NCT IDStudyPhase / statusEnrollmentUpdated
A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight
Novo Nordisk · Obesity · Type 2 Diabetes
Phase 3
Recruiting
2,500
2026-07
A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term
Novo Nordisk · Obesity
Phase 3
Active, not recruiting
609
2026-07
A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight
Novo Nordisk · Obesity
Phase 3
Active, not recruiting
3,400
2026-07
REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels
Novo Nordisk · Cardiovascular Disease
Phase 3
Active, not recruiting
7,101
2026-07
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both
Novo Nordisk · Diabetes Mellitus, Type 2
Phase 3
Completed
1,023
2026-07
A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight
Novo Nordisk · Overweight · Obesity
Phase 3
Recruiting
460
2026-07
A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes
Novo Nordisk · Diabetes Mellitus, Type 2
Phase 2
Withdrawn
0
2026-07
A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight
Novo Nordisk · Overweight · Obesity
Phase 3
Withdrawn
0
2026-07
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.