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RecruitingPhase 1

A Research Study Looking Into How Cagrilintide Influences Food Intake and Appetite in People With Overweight or Obesity

A Study Investigating the Effect of Cagrilintide on Energy Intake and Appetite in People With Overweight or Obesity

Lead sponsor

Novo Nordisk A/S

Asset

CagriSema / cagrilintide

Subcutaneous · GLP-1 / amylin

Listed sites

1

Recruiting sites

1

Enrollment

120

estimated

Study population

Obesity / overweight

Key I/E criterion

Primary endpoint

Total energy intake across ad libitum breakfast, lunch, evening meal

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 IDNCT07557953
Org study IDNN9833-8421
Secondary ID2025-524206-15European Medical Agency (EMA)
Secondary IDU1111-1325-8810World Health Organization (WHO)

Timeline

Milestones

Study first posted2026-04-30actual
Study start2026-04-30actual
Last update posted2026-05-15actual
Primary completion2027-04-13estimated
Study completion2027-04-13estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age64 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Male or female (sex at birth).
Age 18-64 years (both inclusive) at the time of signing the informed consent.
Body mass index (BMI) is greater than or equal to (≥) 27.0 kg/m^2 at screening. Over-weight should be due to excess adipose tissue, as judged by the investigator.
Considered to be generally healthy, except for overweight or obesity, 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.

Exclusion criteria

Known or suspected hypersensitivity to study intervention(s) or related products.
Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
Glycated haemoglobin (HbA1c) ≥ 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 at-tempts (e.g., participation in a weight reduction program) within 90 days before screening.
Use of incretin therapies within the last 6 months prior to screening or previous discontinuation of incretin therapy due to tolerability issues.
Use of any weight lowering pharmacotherapy or pharmacotherapy that may cause weight gain, including systemic corticosteroids (except for a short course of treatment, i.e., 7-10 days), tri-cyclic antidepressants, atypical antipsychotic and mood stabilisers 6 months prior to screening.
Previous dosing of marketed or non-marketed amylin-based compounds.

Endpoints (10)

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
6
Other clinical outcomes
2
Other (unclassified)
2

Patient-reported / QoL

6 endpoints
Secondary/protocol endpoint

Change in mean postprandial appetite score (AS) based on Visual Analogue Scale (VAS)

Time frame:From baseline (Day 1) to end of treatment (Day 126)

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:From baseline (Day 1) to end of treatment (Day 126)

change from baseline, improvement

Secondary/protocol endpoint

Change in mean postprandial VAS ratings of: visual appearance, taste and overall pleasantness

Time frame:From baseline (Day 1) to end of treatment (Day 126)

change from baseline, improvement

Secondary/protocol endpoint

Change in fasting VAS appetite ratings of: Hunger, fullness, satiety, prospective food consumption and AS

Time frame:From baseline (Day 1) to end of treatment (Day 126)

change from baseline, improvement

Secondary/protocol endpoint

• Change in mean Control of Eating questionnaire (CoEQ), domain: Craving Control score, positive mood score, craving for sweets score, craving for Savory food score

Time frame:From baseline (Day -1) to end of treatment (Day 125)

change from baseline, improvement

Secondary/protocol endpoint

Change in mean Power of Food questionnaire for: food available score, food present score, food tasted score, composite score

Time frame:From baseline (Day -1) to end of treatment (Day 125)

change from baseline, improvement

Other clinical outcomes

2 endpoints
Secondary/protocol endpoint

Change in total amount of food consumed across ad libitum breakfast, lunch, evening meal and snack box

Time frame:From baseline (Day 2) to end of treatment (Day 127)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Absolute change in energy intake of high fat + sweet, high fat + non-sweet, low fat + sweet, low fat + non sweet in the evening snack box

Time frame:From baseline (Day 2) to end of treatment (Day 127)

change from baseline, improvement

Other (unclassified)

2 endpoints
Primary/protocol endpoint/low confidence

Relative change in total energy intake across ad libitum breakfast, lunch, evening meal and snack box

Time frame:From baseline (Day 2) to end of treatment (Day 127)

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in total energy intake across ad libitum breakfast, lunch, evening meal and snack box

Time frame:From baseline (Day 2) to end of treatment (Day 127)

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.