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Completed

NCT Number: NCT06267092

A Study of How CagriSema Works on Appetite in People With Excess Body Weight

Part A: The study will look at participants appetite and energy intake and also look at the mechanisms of brain associated with appetite and food intake. Participants will not get any medicine and will be in a group that will be compared to another group receiving a weight-loss medicine. The study will last for about 6 months.

Part B: The study will look at how CagriSema works on participants appetite and energy intake and will be compared with a ''dummy'' medicine. The study will also look at how participants brain works when participants take the medicine. Participants will either get CagriSema or ''dummy'' medicine.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Charité - Campus Charité Mitte - Charité Research Organisation GmbH

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female
  • Aged 18-65 years (both inclusive) at the time of signing informed consent
  • Right-handed as evaluated by the Edinburgh Handedness Inventory
  • Body weight less than or equal to 180 kilogram at screening

For Part A:

  • A score of 7 or less on the 16-item Disinhibition subscale of the Three Factor Eating Questionnaire
  • Body mass index between 18.5 and 24.9 kilogram per meter square (both inclusive) at screening

For Part B:

  • A score of 8 or more on the 16-item Disinhibition subscale of the Three Factor Eating Questionnaire
  • Body mass index equal to or above 27.0 kilogram per meter square. Overweight should be due to excess adipose tissue, as judged by the investigator

Exclusion criteria

  • Contraindication for magnetic resonance scanning

For Part B:

  • Glycated haemoglobin greater than or equal to 6.5 % (48 millimoles per mole) at screening
  • History of type 1 or type 2 diabetes mellitus

Treatment and study plan

No treatment given

Other

Participants will not get any medicine during this study.

Cagrilintide and semaglutide

Drug

Participants will receive subcutaneous (s.c.) injections of Cagrilintide and Semaglutide.

Placebo

Drug

Participants will receive subcutaneous (s.c.) injections of placebo matched to Cagrilintide and Semaglutide.

Primary outcomes

  1. Change in mean postprandial appetite score based on visual analogue scale (VAS)

    Time frame: Baseline to week 24

    Measured in millimeter. 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.

Secondary outcomes

  1. Change in mean postprandial VAS ratings of: hunger, fullness, satiety and prospective food consumption

    Time frame: Baseline to week 24

    Measured in millimeter

  2. Change in average DAILY EATS questionnaire scores over one week for: average hunger, worst hunger, appetite, cravings, satiety and eating drivers index composite score

    Time frame: Baseline pre-treatment ((Day 4 - Day 10) to treatment (Day 156 - Day 162))

    Measured in score points. The DAILY EATS is a 5-item, self-reported measure assessing key eating-related factors (Worst and Average Hunger, Appetite, Cravings, and Satiety). Additionally, an eating drivers index (EDI), comprising the related items Worst Hunger, Appetite, and Cravings can be calculated using this questionnaire. An 11-point numerical rating scale (0-10) is used for each item, with a higher value indicating more hunger, bigger appetite, stronger cravings, or greater satiety.

  3. Change in control of eating questionnaire (COEQ), 4 domains: craving control score, positive mood score, craving for sweets score and craving for savoury food score

    Time frame: Baseline to week 24

    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.

  4. Change in power of food questionnaire for: food available score, food present score, food tasted score and composite score

    Time frame: Baseline to week 24

    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").

  5. Change in blood oxygen level dependant (BOLD) response to food cues in the brain reward areas

    Time frame: Baseline to week 24

    Measured in percentage

  6. Relative change in total energy intake during ad libitum lunch, evening meal and snackbox

    Time frame: Baseline to week 24

    Measured in percentage

  7. 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 week 24

    Measured in percentage point

  8. Change in total energy intake during ad libitum lunch, evening meal and snackbox

    Time frame: Baseline to week 24

    Measured in kilojoules

  9. Change in total amount of food consumed during ad libitum lunch, evening meal and snackbox

    Time frame: Baseline to week 24

    Measured in grams

  10. Change in body weight

    Time frame: Baseline to week 24

    Measured in percentage

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

An Investigation of the Effect of Cagrilintide and Semaglutide Combination Treatment (CagriSema) on Appetite and Functional Brain Activity in People With Overweight or Obesity

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 20, 2024
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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