A Research Study to Look at How CagriSema Influences Food Intake, Appetite and Emptying of the Stomach in People With Excess Body Weight

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

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 Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: Cagrilintide; Drug: Placebo; Drug: Semaglutide

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14050
    • Parexel International GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CagriSema; 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.	Drug: Cagrilintide; Cagrilintide will be administered subcutaneously.; Drug: Semaglutide; Semaglutide will be administered subcutaneously.
Active Comparator: Placebo; Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously once-weekly for 21 weeks.	Drug: Placebo; Placebo will be administered subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative change in energy intake during ad libitum lunch, evening meal and snackbox	Measured in percentage (%).	Baseline to Day 156

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in energy intake during ad libitum lunch, evening meal and snackbox	Measured in kilojoule (KJ).	Baseline to Day 156
Change in amount of food consumed during ad libitum lunch, evening meal and snackbox	Measured in grams (g).	Baseline to Day 156
AUC0-5h,para, area under the paracetamol concentration-time curve from 0 to 5 hours after start of standardised meal	Measured in hour*milligram per milliliter ( h*mg/mL).	Day 1 and Day 155: 0-5 hour after standardised meal
AUC0-1h,para, area under the paracetamol concentration-time curve from 0 to 1 hour after start of standardised meal	Measured in h*mg/mL.	Day 1 and Day 155: 0-1 hour after standardised meal
Cmax,para, maximum observed paracetamol concentration	Measured in microgram per milliliter (µcg/mL).	Day 1 and Day 155: 0-5 hour after standardised meal
tmax,para, time to maximum observed paracetamol concentration after start of standardised meal	Measured in hours (h).	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	Measured in %-point.	Baseline to Day 156
Change in Control of Eating questionnaire (COEQ): Craving Control score	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.	Baseline to Day 154
Change in COEQ: Positive Mood score	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.	Baseline to Day 154
Change in COEQ: Craving for Sweets score	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.	Baseline to Day 154
Change in COEQ: Craving for Savoury food score	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.	Baseline to Day 154
Change in mean postprandial Visual Analogue Scale (VAS) ratings of Hunger	Measured in millimeter (mm). VAS appetite questions record the participants' sensations within Hunger, Satiety, Fullness, 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.	Baseline to Day 156
Change in mean postprandial VAS ratings of Fullness	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.	Baseline to Day 156
Change in mean postprandial VAS ratings of Satiety	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.	Baseline to Day 156
Change in mean postprandial VAS ratings of Prospective food consumption	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.	Baseline to Day 156
Change in mean postprandial VAS ratings of Appetite Score	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.	Baseline to Day 156
Change in Power of Food questionnaire for Food available score	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").	Baseline to Day 155
Change in Power of Food questionnaire for Food present score	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").	Baseline to Day 155
Change in Power of Food questionnaire for Food tasted score	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").	Baseline to Day 155
Change in Power of Food questionnaire for Composite score	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").	Baseline to Day 155
Change in mean score from the Monetary Choice Questionnaire	The 27-item version of the Monetary Choice Questionnaire63 is used to assess participants' individual preference for immediate versus delayed monetary rewards. The questions comprise hypothetical choices between smaller immediate rewards or larger delayed rewards. The specific amounts and delays of the rewards vary across questions. For each question, the participant is asked to choose which option they would prefer. The responses are used to calculate a measure of participants' willingness to delay gratification and their discount rate (k) for delayed rewards.	Baseline to Day 157
Change in body weight	Measured in %.	Baseline to Day 155

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S'

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2024
• Primary Completion (Actual): October 16, 2024
• Study Completion (Actual): November 22, 2024

Study Registration Dates

• First Submitted: January 5, 2024
• First Submitted That Met QC Criteria: January 5, 2024
• First Posted (Actual): January 17, 2024

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Glucagon-Like Peptide-1 Receptor Agonists; Physiological Effects of Drugs; Hypoglycemic Agents; semaglutide; cagrilintide
• Other Study ID Numbers: NN9838-4695; U1111-1286-0585 (Other Identifier: World Health Organization (WHO)); 2023-504792-24-00 (Other Identifier: European Medical Agency (EMA))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No