GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3

A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight

Efficacy and Safety of Cagrilintide 2.4 mg s.c. in Combination With Semaglutide 2.4 mg s.c. (CagriSema s.c. 2.4 mg/2.4 mg) Once-weekly Compared to Tirzepatide 15 mg s.c. Once-weekly in Participants With Obesity

Lead sponsor

Novo Nordisk A/S

Assets

CagriSema / cagrilintide / Semaglutide / Tirzepatide

Listed sites

Recruiting sites

—

Enrollment

809

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥30

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 IDNCT06131437

Org study IDNN9838-7832

Secondary IDU1111-1292-4835World Health Organization (WHO)

Timeline

Milestones

Study first posted2023-11-14actual

Study start2023-11-27actual

Primary completion2025-12-08actual

Study completion2026-01-09actual

Last update posted2026-02-06actual

Assets

Investigational agents

CagriSema / cagrilintide Semaglutide Tirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female

•Age 18 years or above at the time of signing the informed consent

•Body mass index (BMI) of ≥ 30.0 kilogram per square meter (kg/m^2)

Exclusion criteria

•Glycated 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 mellitus

Endpoints (15)

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

Cardiometabolic biomarkers

Weight & body composition

Safety / tolerability / PK

Weight & body composition

5 endpoints

Primary/protocol endpoint

To confirm non-inferiority of CagriSema versus tirzepatide: Relative change in body weight

Time frame:From baseline (week 0) to end of treatment (week 84)

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

To confirm superiority of CagriSema versus tirzepatide: Relative change in body weight

Time frame:From baseline (week 0) to end of treatment (week 84)

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Achievement of greater than or equal to (≥) 25% weight reduction

Time frame:From baseline (week 0) to end of treatment (week 84)

≥25% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Achievement of ≥ 30% weight reduction

Time frame:From baseline (week 0) to end of treatment (week 84)

threshold achievement, improvement

Secondary/protocol endpoint

Change in waist circumference

Time frame:From baseline (week 0) to end of treatment (week 84)

Waist circumference, change

change from baseline, improvement

Cardiometabolic biomarkers

8 endpoints

Secondary/protocol endpoint

Change in systolic blood pressure (SBP)

Time frame:From baseline (week 0) to end of treatment (week 84)

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in diastolic blood pressure (DBP)

Time frame:From baseline (week 0) to end of treatment (week 84)

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Relative change in lipids: Total cholesterol

Time frame:From baseline (week 0) to end of treatment (week 84)

Total cholesterol, change

percent change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Relative change in lipids: High-density lipoprotein (HDL) cholesterol

Time frame:From baseline (week 0) to end of treatment (week 84)

HDL-C, change

percent change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Relative change in lipids: Non-HDL cholesterol

Time frame:From baseline (week 0) to end of treatment (week 84)

Non-HDL cholesterol, change

percent change from baseline, improvement

Secondary/protocol endpoint

Relative change in lipids: Low-density lipoprotein (LDL) cholesterol

Time frame:From baseline (week 0) to end of treatment (week 84)

LDL-C, change

percent change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Relative change in lipids: Very low-density lipoprotein (VLDL) cholesterol

Time frame:From baseline (week 0) to end of treatment (week 84)

VLDL, change

percent change from baseline, improvement

Secondary/protocol endpoint

Relative change in lipids: Triglycerides

Time frame:From baseline (week 0) to end of treatment (week 84)

Triglycerides, change

percent change from baseline, improvement

LOINC 2571-8

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Number of Treatment-emergent Adverse Events (TEAEs)

Time frame:From baseline (week 0) to end of study (week 90)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Treatment Emergent Serious adverse events (TESAEs)

Time frame:From baseline (week 0) to end of study (week 90)

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.