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CompletedPhase 1

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

Lead sponsor

Novo Nordisk A/S

Assets

CagriSema / cagrilintide / Semaglutide

Listed sites

1

Recruiting sites

Enrollment

62

actual

Study population

Obesity / overweight

Key I/E criterion

BMI ≥27

Primary endpoint

Energy intake during ad libitum lunch, evening meal and snackbox

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 IDNCT06207877
Org study IDNN9838-4695
Secondary ID2023-504792-24-00European Medical Agency (EMA)
Secondary IDU1111-1286-0585World Health Organization (WHO)

Timeline

Milestones

Study first posted2024-01-17actual
Study start2024-02-23actual
Primary completion2024-10-16actual
Study completion2024-11-22actual
Last update posted2026-01-08actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / 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.
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.

Endpoints (23)

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
12
Safety / tolerability / PK
4
Other clinical outcomes
4
Other (unclassified)
2
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change in body weight

Time frame:Baseline to Day 155

Body weight, % change

percent change from baseline, improvement

Patient-reported / QoL

12 endpoints
Secondary/protocol endpoint

Change in Control of Eating questionnaire (COEQ): Craving Control score

Time frame:Baseline to Day 154

change from baseline, improvement

Secondary/protocol endpoint

Change in COEQ: Positive Mood score

Time frame:Baseline to Day 154

change from baseline, improvement

Secondary/protocol endpoint

Change in COEQ: Craving for Sweets score

Time frame:Baseline to Day 154

change from baseline, improvement

Secondary/protocol endpoint

Change in COEQ: Craving for Savoury food score

Time frame:Baseline to Day 154

change from baseline, improvement

Secondary/protocol endpoint

Change in mean postprandial VAS ratings of Fullness

Time frame:Baseline to Day 156

change from baseline, improvement

Secondary/protocol endpoint

Change in mean postprandial VAS ratings of Satiety

Time frame:Baseline to Day 156

change from baseline, improvement

Secondary/protocol endpoint

Change in mean postprandial VAS ratings of Prospective food consumption

Time frame:Baseline to Day 156

change from baseline, improvement

Secondary/protocol endpoint

Change in mean postprandial VAS ratings of Appetite Score

Time frame:Baseline to Day 156

change from baseline, improvement

Secondary/protocol endpoint

Change in Power of Food questionnaire for Food available score

Time frame:Baseline to Day 155

change from baseline, improvement

Secondary/protocol endpoint

Change in Power of Food questionnaire for Food present score

Time frame:Baseline to Day 155

change from baseline, improvement

Secondary/protocol endpoint

Change in Power of Food questionnaire for Food tasted score

Time frame:Baseline to Day 155

change from baseline, improvement

Secondary/protocol endpoint

Change in Power of Food questionnaire for Composite score

Time frame:Baseline to Day 155

change from baseline, improvement

Safety / tolerability / PK

4 endpoints
Secondary/protocol endpoint

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

concentration, descriptive

Secondary/protocol endpoint

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

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,para, maximum observed paracetamol concentration

Time frame:Day 1 and Day 155: 0-5 hour after standardised meal

Cmax

concentration, descriptive

Secondary/protocol endpoint

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

Tmax

descriptive

Other clinical outcomes

4 endpoints
Secondary/protocol endpoint

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

Time frame:Baseline to Day 156

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 Day 156

change from baseline, improvement

Secondary/protocol endpoint

Change in mean postprandial Visual Analogue Scale (VAS) ratings of Hunger

Time frame:Baseline to Day 156

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in mean score from the Monetary Choice Questionnaire

Time frame:Baseline to Day 157

change from baseline, improvement

Other (unclassified)

2 endpoints
Primary/protocol endpoint/low confidence

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

Time frame:Baseline to Day 156

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

Time frame:Baseline to Day 156

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.