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Not yet recruitingPhase 3

A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight

A Placebo-controlled Comparability Study to Compare Two Presentations of CagriSema in Participants With Overweight or Obesity

Lead sponsor

Novo Nordisk A/S

Assets

CagriSema / cagrilintide / Semaglutide

Listed sites

116

Recruiting sites

Enrollment

1,400

estimated

Study population

Obesity / overweight

Key I/E criterion

Primary endpoint

Body weight, % change

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 IDNCT07357766
Org study IDNN9838-8166
Secondary ID2024-520448-41European Medical Agency (EMA)
Secondary IDU1111-1317-0133World Health Organization

Timeline

Milestones

Study first posted2026-01-22actual
Last update posted2026-02-25actual
Study start2026-06-22estimated
Primary completion2027-11-29estimated
Study completion2028-01-17estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Male or female (sex at birth)
Age 18 years or above at the time of signing the informing consent.
Body Mass Index (BMI) is greater than or equal to (>= ) 30.0 kilograms per square metre (kg/m^2) or BMI >= 27.0 kg/m^2 with the presence of at least one obesity-related complication including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.

Exclusion criteria

Glycosylated haemoglobin (HbA1c) >= 6.5 % (48 millimoles per mole [mmol/mol]) as measured by the central laboratory at screening.
History of type 1 or type 2 diabetes.
Previous exposure to CagriSema in a clinical study.

Endpoints (3)

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

Safety / tolerability / PK
2
Weight & body composition
1

Weight & body composition

1 endpoint
Primary/protocol endpoint

Relative change in body weight

Time frame:From baseline (week 0) to end of treatment (week 44)

Body weight, % change

percent change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

Number of TEAEs (treatment emergent adverse events)

Time frame:From baseline (week 0) to end of study (week 51)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of TESAEs (Treatment emergent serious adverse events)

Time frame:From baseline (week 0) to end of study (week 51)

Serious AEs (any)

event count, event

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.