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OverweightPhase 1NCT06267092

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

A Phase 1 study testing No treatment given and Cagrilintide and Semaglutide in people with Overweight and Obesity, run by Novo Nordisk A/S at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Overweight, Obesity
What is being tested?
No treatment given and Cagrilintide and Semaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
164 participants
Where
1 siteGermany
Study dates
15 Feb 2024to 8 Dec 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Charité - Campus Charité Mitte - Charité Research Organisation GmbH

    Berlin, 10117

Other trials in Germany

About this study

Official 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

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.

Conditions
Overweight, Obesity
Being tested
No treatment given, Cagrilintide and Semaglutide, Placebo
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No treatment givenOther

    Participants will not get any medicine during this study.

  • Cagrilintide and SemaglutideDrug

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

  • PlaceboDrug

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

Study groups in NCT06267092
Study groupRoleWhat they receive
Part AOtherParticipants will not get any medicine during this study.
Receives: Other: No treatment given
Part BExperimentalParticipants will receive CagriSema or placebo (Dose 1,2,3,4) for 16-weeks dose-escalation period followed by 37-weeks intervention period on CagriSema or placebo (Dose 5) that includes a 12-day standardised energy intake period.
Receives: Drug: Cagrilintide and Semaglutide; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Baseline to week 24

Secondary outcomes (10)

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

    Measured in millimeter

    Measured: Baseline to week 24

  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

    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.

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

  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

    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.

    Measured: Baseline to week 24

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

    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").

    Measured: Baseline to week 24

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

    Measured in percentage

    Measured: Baseline to week 24

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

    Measured in percentage

    Measured: Baseline to week 24

  7. Change in percent energy intake of high fat, sweet food in total ad libitum energy intake in the evening snack box

    Measured in percentage point

    Measured: Baseline to week 24

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

    Measured in kilojoules

    Measured: Baseline to week 24

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

    Measured in grams

    Measured: Baseline to week 24

  10. Change in body weight

    Measured in percentage

    Measured: Baseline to week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2024
  2. Study start15 Feb 2024
  3. Primary completion7 Apr 2025
  4. Study completion8 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
164 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06267092
Sponsor's protocol ID
NN9838-4944
Status last verified
Jan 2026
First submitted
12 Feb 2024
Last updated
8 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing No treatment given and Cagrilintide and Semaglutide in people with Overweight and Obesity, run by Novo Nordisk A/S at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in mean postprandial appetite score based on visual analogue scale (VAS) (time frame: Baseline to week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06267092.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.

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