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CompletedPhase 1

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

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

Lead sponsor

Novo Nordisk A/S

Assets

CagriSema / cagrilintide / Semaglutide

Listed sites

1

Recruiting sites

Enrollment

164

actual

Study population

Healthy volunteers, Obesity / overweight

Key I/E criterion

BMI 18.5-24.9

Primary endpoint

Mean postprandial appetite score

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06267092
Org study IDNN9838-4944

Timeline

Milestones

Study start2024-02-15actual
Study first posted2024-02-20actual
Primary completion2025-04-07actual
Study completion2025-12-08actual
Last update posted2026-01-08actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (11)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Patient-reported / QoL
5
Other clinical outcomes
4
Weight & body composition
1
Other (unclassified)
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change in body weight

Time frame:Baseline to week 24

Body weight, % change

percent change from baseline, improvement

Patient-reported / QoL

5 endpoints
Primary/protocol endpoint

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

Time frame:Baseline to week 24

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline to week 24

change from baseline, improvement

Secondary/protocol endpoint

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))

change from baseline, improvement

componentsaverage hunger, worst hunger, appetite, cravings, satiety, eating drivers index (EDI) composite score

Secondary/protocol endpoint

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

change from baseline, improvement

Secondary/protocol endpoint

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

change from baseline, improvement

Other clinical outcomes

4 endpoints
Secondary/protocol endpoint

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

Time frame:Baseline to week 24

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

Time frame:Baseline to week 24

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline to week 24

change from baseline, improvement

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

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

Time frame:Baseline to week 24

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.